Hub van den Boomen, Kim Stoltz, Wouter Akkerman, Esther Mik en Tim Dries
'An effectiveness study into orthopedic devices'
Freedom of movement now truly proven
Amsterdam 2023
freedom of movement now truly proven
©2023 Livit Orthopedie All rights reserved. No part of this publication may be reproduced, stored in an automated data file, or made public, in any form or by any means, whether electronic, mechanical, photocopying or recording, or in any other way, without the prior written consent of Livit Orthopedics. Insofar as the making of copies of this publication is permitted on the basis of Article 16b of the Copyright Act, Decree of 20 June 1974m Stb. 351, as amended by the Decree of 23 August 1985, Stb. 471 and Article 17 of the Copyright Act, the statutory fees must be paid to the Reprorecht Foundation (P.O. Box 3060,2130 KB Hoofddorp). To copy (a) part(s) of this edition in anthologies, readers, and other compilation works (Article 16 of the Copyright Act), livit Orthopedics should be contacted. Editor(s) and publisher are fully aware of their task to provide a reliable publication. Nevertheless, they cannot accept any liability for printing errors and other inaccuracies that may occur in this publication. ISBN 978 940 219 876 8 NUR 801
2 - INLEIDING
Editor in Chief: Jan Willem van der Windt Contact: 088 - 245 2000 / redactie@livit.nl The contents of this booklet have been compiled with utmost care by Livit’s editorial team in collaboration with clients, referrers and reputable medical information sources. Privacy rules have been fully respected in this process. Livit is not responsible for any inaccuracies in this publication. No part of this publication may be duplicated or published without the prior written consent of Livit Orthopedie, Kabelweg 40, 1014 BB, Amsterdam.
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Study design and integrated approach effectiveness study into orthopedic devices
orteam® afo, Users of the ORTEAM AFO experience 50% more improvement in walking possibilities than users of a conventional plastic AFO!
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ADAPT-IT, Adjust the pressure distribution of the 3D Printed socket for trans-tibial prosthesis with one “click” based on stump volume changes.
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orthopedic corset, Improved mobility and reduced pain when wearing a corset for patients with chronic low back pain
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prologue; The patient and their data as partners in care
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silversplints, Patient reported outcome of silversplints used for osteoarthritis of the hand.
knee brace, Improved mobility and reduced pain when wearing a (semi-)rigid knee brace for individuals with knee osteoarthritis.
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silicone who, Reduced pain and improved daily activities for individuals with Hand osteoarthritis using a silicone wrist hand orthosis
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From the Editor
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elastic stockings, Efficacy and therapy compliance of compression therapy with the use of therapeutic elastic stockings
With this book, Livit Orthopedie wants to contribute to the promotion of transparency in orthopedic care and support physicians, specialists, and patients in creating the best care plan for the patient. We do this by sharing the outcomes of our effectiveness studies in this book, across various (custom-made) provisions. This book is available to download from zorgprofessionals.livit.nl, and hardcopies will be available in waiting rooms at Livit locations and a number of outpatient clinics at hospitals, institutions, and rehabilitation centers. It is also available to order from bol.com. All proceeds will go to the Liliane Fonds, a Dutch foundation for children with a handicap in Africa, Asia and Latin-America.
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introduction, outcome information about illness and treatment increasingly important to patients
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About this book
The (co-)Authors: Bram Hentenaar, Orthopaedic Surgeon at Diakonessenhuis, Utrecht Ina Sissingh, Scholing - en adviesbureau compressietherapie Jeroen Groot, Medical Doctor at 'Reade revalidatie en reumatologie', Amsterdam Martijn Pas, Medical Doctor at Bravis Ziekenhuis Roosendaal Bergen op Zoom Marloes Hofstra, MSc in Occupational Therapy, Xpert Handtherapie, Rotterdam, Nienke Roux, Medical Doctor, Basalt, Vrederustlaan 180, 2543 SW, Den Haag, The Netherlands. Rob P.A. Janssen, Medical Doctor (MD PhD); Departmentof Orthopaedic Surgery & Trauma, Máxima Medical Center, Eindhoven-Veldhoven, (2) Orthopaedic Biomechanics, Department of Biomedical Engineering, Eindhoven University of Technology, The Netherlands; (3) Value-Based Health Care, Department of Paramedical Sciences, Fontys University of Applied Sciences, Eindhoven, The Netherlands Bart de Kiefte, CTO at Livit Orthopedie, Dordrecht Bas van den Brand, CPO and regional manager at Livit Orthopedie, Dordrecht Esther Mik, Directeur Zorg en Allianties at Livit Orthopedie, Amsterdam Frank Bosch, CPO at Livit Orthopedie, Den Haag Gerrit van Zuijlen, CPO at Livit Orthopedie, Den Bosch Hub van den Boomen, Managing Director Livit Orthopedie, Dordrecht Jan van de Werken, Technical advisor to management of Livit Orthopedie Jan Willem Van der Windt, MSc, Research Institute Livit Orthopedie, Amsterdam Kim Stoltz, Cluster Head Ottobock GNR, Dordrecht Leen Nugteren, CPO, Livit Orthopedie, Rotterdam, Netherlands Marcella van der Ent, Technical Engineer at Livit Orthopedie Marco Toor, CPO and regional manager at Livit Mari Kluijtmans, CPO, Livit Orthopedie, Eindhoven Marjolijn Geerlofs BSc, Consulent Therapeutisch Elastische Kousen, Huidtherapeut, Livit Orthopedie, Breda Peter Meussen, CPO at Livit Orthopedie, Zwolle Pieter van der Snoek, CPO at Livit Orthopedie, Dordrecht Sabine Kuhne, CPO at Livit Orthopedie, Dordrecht Tim Dries, MSc, ProductManager Livit Orthopedie, Dordrecht, Netherlands Wouter Akkerman, CPO, Director Operational Management at Livit Orthopedie, Dordrecht Wouter de Vos, CPO and regional manager at Livit Orthopedie, Rotterdam
The patient as a fully-fledged discussion partner The patient as a fully-fledged discussion partner in the formulation and realization of their own care plan: that is where we are heading within the healthcare system. This is already what happens in an increasing number of cases. But why not everywhere just yet, I wondered recently. I arrived at the following, somewhat gloomy, thought: could it be because of our own soap box? The soap box called ‘the science’ or perhaps even ‘the specialist’, where the patient’s opinion or feelings are not real science? Could that be why for us, specialists, it is rather difficult to genuinely regard the patient as a fully-fledged discussion partner, and therefore as a co-determiner of their own care plan? Do we, every now and then, secretly long for the days when the doctor was still a specialist on a pedestal? Surely not? This thought is best forgotten, and quick. Besides, there is good news! Science serves us even in this instance. Thank goodness, I hear you think. Evidence Based Medicine is a way of working that is based on the best scientific evidence of the effect of a treatment method. But in a context-dependent healthcare system, clinical experience and patient wishes and values also play a major part in the provision of good care in the consulting room (Raad van Volksgezondheid en Sport [Public Health and Sports Council], 2017, red.). The rise in the amount of outcome information from Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experiences (PREMs) enables us to reliably demonstrate the effect of our treatments on our patients’ perceived health and daily functioning. Never mind subjective opinions: this is science too! That is why I am happy that Livit has been conducting large-scale PROMs and PREMs among its clients for a number of years. It means we now have a large amount of data at our disposal, about the effect of the use of orthopedic devices and aids on the patients’ perceived health and daily functioning. Valuable additional information that can help us deliver patient-centered care in the consulting room. A good example of how - together - we can improve care for people by sharing data we each have. As such, I would like to urge you to read this reference book by Livit, and to take into account the outcomes of the various studies as well as traditional hardcore scientific evidence when structuring treatment plans together with your patient. Please don’t forget the latter above all: to involve your patients in setting up their own treatment plan. From experience, I can tell you (and prove it) that not only will it make your work more fun and more interesting, the help you give your patients will be even better too. In short, by regarding patients as partners and (co-)owners of their own care process, our joint contribution to making sure the patient can participate again is enhanced. Annette van Kuijk Medical Director and Rehabilitation Physician at Tolbrug rehabilitation center / Jeroen Bosch Hospital Den Bosch, and Board member of the Association of Rehabilitation Physicians (VRA)
prologue The patient and their data as partners in care
Medical care is changing constantly, with the (rightfully) ever more assertive and empowered human being as one of the drivers. Right now, we are on the brink of a breakthrough in the way healthcare works, whereby the medical specialists no longer form the multidisciplinary team around the patient, but instead form a team with the patient and their closest relatives.
An understanding of one’s own health situation is important for the patient as well as the care provider.
1 - prologue
Transparency in care is essential to improve the quality of care across the board. Information about disorders and illnesses, treatments and their effectiveness play an increasingly important role in the quest of both patient and care professional to gain insight in and an understanding of the patient’s health situation. A need that is present in both groups, according to Nivel research [Netherlands Institute for Health Services Research][i]. By making the patient-reported outcome measures of various orthopedic devices available, Livit aims to fulfil this need for information and as such, facilitate transparency in care.
A poll of the Dutch population (2017, Nivel) found that people now frequently search for information about health complaints and conditions (60% of people) and treatments (37% of people) and less for information about care providers (17% of people). Nowadays, people mostly look for information that provides insight into what is wrong with them and what might help them. Increasingly, this involves information about the effects of different treatments. In addition, the role of such information has become increasingly important. For example, it is used more and more often in joint decision-making about the care path to be followed by healthcare provider and patient. (source: Nivel Transparency Monitor[ii]). Evidence-based Contemporary medicine prefers to base itself on science, or in other words the best treatment should be scientifically substantiated. In recent decades, evidence-based practice (EBP) has gained prominence in medicine and in healthcare. Unfortunately, orthopedic care is still a minor part of this in our country. By sharing the patient-reported outcome measures of various orthopedic devices, Livit aims to contribute to the improvement of orthopedic care in the Netherlands. Evidence-based working is often thought to only involve knowledge that provides scientific evidence or whether a method of intervention is effective. Scientific knowledge is an important source, but in evidence-based work it is also important to look at the experiences of experts, practitioners themselves, and users. It is essential to consult multiple sources as a basis for evidence-based working. As such, evidence-based working has evolved in recent years, from a purely biomedical model with ‘hard’ clinical parameters such as mortality and morbidity to a more bio-psychosocial model that prioritizes the psychosocial aspects, such as the clients’ perceived health and quality of life. It means healthcare is shifting from the no-frills provision of medical treatment to information on and support for participation in work, family, sports and leisure activities. Livit is confident that this shift means evidence-based working will become a major part of orthopedic care too. Livit uses the following practical definition here: Evidence-based working is action based on the best available information about the efficiency and effectiveness of a methodology or approach. It is about rationalizing our actions to ‘the best of our knowledge’.The emergence of PROM researchIn June 2018, Zorginstituut Nederland [Care Institute Netherlands] issued advice on the direction to take to have outcome information available for 50% of disease burden by 2022. This ambition means that by 2022, patient and healthcare provider will have access to outcome information, such as perceived pain reduction and level of functioning. With this, the interest in doing research based on so-called PROMs is growing: Patient-Reported Outcome Measure. PROM research is a method for measuring health outcomes and quality of life that offers insight into the (added) value of patient care, and as such, contributes to improving the quality of said care. This information is usable at two levels: at individual level to benefit individual patient care, and at aggregate (group) level to benefit quality improvement, transparency, and research. Livit has integrated PROMs into its care pathways for individual clients and also uses the outcomes for quality improvement at aggregate level. PREM AND PROM research by Livit Those who are healthy might not give it much thought, but general activities in daily life (ADL) such as household chores, grocery shopping, or cooking can be a recurring struggle for people with a disability. An impairment or disability can make simple activities so difficult that people sometimes just stop doing them altogether. The extent to which you are able to carry out your general activities of daily living independently is a healthcare parameter used to determine whether and which care or aids you need. Since 2016, Livit has been conducting ongoing research on the satisfaction and effect of orthopedic devices. At the time of publication of this issue, more than 125,000 clients have been contacted, and over 47,000 clients have provided input. The study is still ongoing. The design After the client takes receipt of their device, Livit asks questions about the wearing comfort, the ease of use, the esthetics, and the contact with the medical specialist and the Livit advisor during the fitting process of the orthotic device. In each case, the questioning refers back to the objectives of the client's provision. The outcomes offer insight into what the client thinks of the device and the service provision, also called PREM (Patient-Reported Experience Measure) research. Livit has also been asking its clients PROM (Patient-Reported Outcome Measure) questions since 2018, to study the effectiveness of the device, measured in ADL (activities of daily living) capabilities gained from the device. By sharing the outcomes of this large-scale PREM and PROM research on the effectiveness of orthopedic devices, Livit wants to contribute to better care for patients who rely on these devices for their general daily activities. And hopes that it will result in better understanding among policy makers, health insurers and physicians that the combination orthotic device use and therapy is a real option to sustainably improve the daily mobility of patients and that this combination could be an excellent alternative to surgery in some cases. What can you expect from this booklet? This book will offer an insight into both client satisfaction and the effectiveness of various orthopedic devices. Chapter 1 details the study design and the subsequent chapters share the outcomes for each product (group). The outcomes can be read separately, but we do advise you to read through the study design first. This will help you to interpret the study results correctly. * Sources: Nivel; Transparantiemonitor [Transparency Monitor] 2018: Broadened transparency in healthcare: from information about healthcare providers to information about effects of treatment,www.nivel.nl Auteurs: Wouter Akkerman (Directeur Operationeel Management Livit Orthopedie), Esther Mik (Directeur Zorg en Allianties), Hub van den Boomen (Managing Director Livit Adviesbedrijf) and Kim Stoltz (Cluster Head Ottobock)
introduction outcome information about illness and treatment increasingly important to patients
An understanding of one’s own health situation is important for the patient as well as the care provider
2 - INTRODUCTION
Patient organizations, healthcare providers, and policy makers are keen to know how patients perceive their health. This is measured with the help of patient-reported outcome measures (PROMs); questionnaires that measure the perceived health, quality of life, and functioning from the patient’s perspective. Zorginstituut Nederland has developed a useful toolbox for anyone who wants to get involved. This PROM toolbox guided the design of Livit’s effectiveness study, the results of which are presented in this book.
Approach The PROM toolbox describes the entire process of selecting and applying PROMs in eight steps. Each step in the toolbox refers to relevant tools and offers practical guidance with real-world examples. The toolbox was developed by IQ Healthcare in collaboration with the Patient-Reported Outcomes (PRO) expertise network on behalf of Zorginstituut Nederland and the Nederlandse Federatie van Universitair Medische Centra consortium Kwaliteit van Zorg [Quality of Care consortium of the Dutch Federation of University Medical Centres]. Establishing the Purpose The first phase of selecting and applying a PROM involves determining and establishing the purpose, the target group, and the setting. Time for demand-driven research (Scientific) research without active patient involvement is now almost unimaginable. Livit joins in the opinion that participation from its clients is an absolute necessity; the research is primarily intended for the clients, after all. We believe that the experiential expertise of those directly involved has been disregarded for too long. This growing realization was a great incentive for setting up research on the use of orthopedic devices within our organization. Research helps explain certain phenomena and demonstrates whether what was devised and deployed actually helps. Scientific research is of great importance for people with chronic conditions or disabilities. For example, the outcomes may ensure that treatments are modified to prevent their condition from getting worse. Which would lead directly to an improved quality of life and improved healthcare in general. Scientific research is conducted in the field of health for a variety of reasons. The aim of the Livit PROM study is to search for possibilities to prevent a condition from worsening, and to measure the effectiveness of the use of orthopedic devices. Livit uses the results obtained to further improve its services, and the quality of services and products. Livit also aims to validate the effectiveness of the use of orthopedic devices. For further clarification, see the table on the right. Target group The target group for this study consists of wearers of orthopedic devices from Livit Orthopedie for whom PROM questions have been devised per device type. The product groups studied include: therapeutic elastic stockings, silver orthoses, silicone wrist-hand orthoses, ankle-foot orthoses, orthotic insoles, back orthoses (corsets), knee braces, and orthopedic shoes (type A and B). The profile of Livit clients with an orthotic device is: two-thirds are 60+, eighty percent is 50+, and the majority are women (sixty percent). Mobility limitations in the elderly Mobility limitations rise sharply with age, especially in women. More than 40% of people over 75 experience limitations in their mobility (30% of men and 49% of women). Across the whole population aged 12 years and over, nearly 10% experience one or more mobility limitations. 5.8% of the Dutch population over the age of 12 experience limitations in daily activities (ADL). This involves limitations such as getting in and out of a chair or bed, or walking up and down the stairs. ADL limitations increase with age. Women are more likely than men to experience ADL limitations.* The setting; an online questionnaire sent via e-mail. The Netherlands is among the leading group of EU-28 countries when it comes to households with Internet access. In 2017, 98% of Dutch households had Internet at home; the European average was 87 percent. The Netherlands is also among the top in terms of fast broadband connections. Internet access for the over-65s group has grown substantially over the last two years, to almost 80%, and two-thirds of this group are also frequent Internet users, half even daily. What’s more, e-mail is a common means of communication for 60% of these users. as was shown by a CBS (Statistics Netherlands) analysis of Eurostat figures.* PRO selection To gain insight into what clients think of its services and products, Livit started a customer satisfaction study in 2016. Prior to this phase, we established what should be measured (PRO) and how it would be measured (PROM). This study asked questions about symptoms, functional status, and perceived health according to the PROM research guidelines from the Zorgvisie Nederland toolkit. PROMs are used to work with the patient to determine which problems in daily functioning are hindering the patient the most. As a result, PROMs can support the discussion of the patient's request for help and the identification of individual objectives in joint decision-making about a treatment plan to be established. Aspects of perceived health or functioning that patients indicate as important cannot always be measured by equipment. This is because it involves aspects of health that cannot be observed ‘objectively’ and are best measured by asking the patient themselves. These patient-reported ‘outcomes’ of perceived health are referred to by the acronym PRO (Patient-Reported Outcome). Examples of PROs are: pain, tiredness, and limitations to daily functioning in relation to work, sports, or household, for example. Such aspects of health are often grouped together under the heading of ‘quality of life’. The aspects of health can be measured at different levels. An illness or condition often leads to complaints and symptoms such as pain, which correlates to issues in daily functioning such as cycling or grocery shopping. Post-treatment measurements provide insight into the effect of treatment on patients' perceived health in terms of their physical and/or mental wellbeing and/or functioning. Selecting PRO, establishing what will be measured. Health is a broad concept and can be measured in many areas. There are plenty of models and classifications already to clarify this. More information is available in the ‘NFU guide to selecting PROs and PROMs'* Selecting PROMs, data interpretation and feedback Standards, outcome indicators, reference values, and context information are essential to interpret the PROM information. This section will explain how this was handled in this study. Outcome indicators An outcome indicator is a specification of the outcomes (effects) of healthcare that offer a clue (indication) about the quality of the care provided. As such, their interpretation is very important in making a judgment about the quality of healthcare providers. The NPS (Net Promoter Score) and the ADL factor were defined as outcome indicators in this study. ADL factor: General activities of daily living (ADL) are the actions people carry out daily in normal life. The term is used primarily in healthcare to determine the extent of a person’s self-reliance. A person that can carry out very few ADL activities independently will need a lot of help. By increasing the ADL with an orthotic device, it directly contributes to increasing a person’s self-reliance. The ADL factor is the outcome indicator for the ADL limitations in functioning with and without the use of an aid or device. Questions are asked on a gradation of mobility (expressed in meters), hindrance (much to no hindrance) and pain (very much worsened to very much improved). The factor is expressed on a scale of 1 to 10 to enable comparison of the different questions. The PROM questions in the study were prepared on the basis of the usual questionnaires familiar in orthopedics (surgery) to create adherence to scientifically accepted and validated PROM questions. Selection PRO, Establishing what will be measured. Net Promotor Score (NPS) The NPS (Net Promotor Score) is used for questions about the customer satisfaction (PREM). NPS is an indicator used to measure customer loyalty. It is an alternative way to measure customer satisfaction. Many companies now embrace this method; it is used by more than two-thirds of the Fortune 1000 companies.* The ‘Net Promoter Score’ was designed by (and a registered method of) Fred Reichheld, Bain & Company and Satmetrix Systems.* Customers are asked about satisfaction with the topic on a scale of 0 to 10. The score is the percentage of 'promotors' (9 or 10) minus the percentage of 'detractors‘ (0 up to and including 6). The 'passives' (7 and 8) are not counted. The score can vary between -100 and +100. An NPS above zero is considered good, a score above 50 is considered excellent. Interpretation Mirror information is needed for quality improvement. In this study, we compare our own scores over time and ‘benchmarks’ in the form of averages across the aggregated data at product level or organizational level (Livit total). Since there are no comparable studies available on the effectiveness of orthopedic devices, it is not possible to use externally oriented standard values or target values. For each study, the context data are clearly presented, including characteristics of the patient population. Minimal clinical difference When does ‘improvement’ really mean ‘improvement for the patient’? Within medical specialist care, the concept of ‘minimal clinical difference’ is often discussed in this context. This is why PROMs are often given an MID (Minimal Important Difference) or MCID (Minimal Clinical Important Difference), both of which indicate the minimum difference that must occur to actually speak of improved health or quality of life. If the score is expressed in mm on a visual analogue scale (VAS), then the mm difference needed to obtain a clinically relevant result is determined. If the score is numerical, the same interpretation applies. For example: the ADAS-Cog score (Alzheimer’s Disease Assessment Scale for the assessment of cognitive functions) varies from 0 to 70. It is generally assumed that a change of 7 points is clinically relevant. An MID of 10 points was used for the outcome indicator NPS, and an MCID of 1.0 points was used for the ADL factor. Quality requirements Livit believes that sharing outcome information helps in choosing a healthcare provider and a treatment/care pathway. The quality of the study is determined by several criteria. Transparency; the extent to which it is possible to verify that the study is reliable. Over the period from 2016 to 2019, Livit clients were asked for their experience feedback on the use of orthopedic devices. To gather the information, a partnership was established with an external research firm specializing in collecting customer data. The information is stored in a database and is constant over the study period. Internal validity; to what extent can the study actually make a judgment about the effectiveness of the orthopedic devices. The study involves clients and patients who all use orthopedic devices and can therefore be classified as experts by experience on the use and the effectiveness of these devices. External validity; to what extent can the study findings also apply to a larger group of people and within other settings. We serve clients throughout the country and in various institutions; from academic hospitals, rehabilitation centers to nursing homes. As such, we serve a broad group and this study can be considered representative of the users of orthopedic devices. Use of PREMs and PROMs Several factors were considered when creating the PREMs and PROMs for Livit. This not only concerned the necessary preconditions, such as the collection of contact data, but also the level of response, user-friendliness and length of the questionnaires and the usability of data and results. Length of questionnaires The length of a questionnaire is a co-determiner for the (time) burden and manageability for the target group. We all know how annoying long questionnaires are. This is often at the expense of the response. For this reason, Livit specifically ensured that the questionnaires were kept as short as possible. Response The response plays a major role in the expressiveness and usefulness of the data collected. The response determines the representativeness and reliability. There is a general trend of declining response rates to surveys and patient experience research. A big challenge for Livit then, to achieve the highest possible response rate. Livit made the client’s feedback part of the care process and included the feedback in the patient file. This makes the feedback available at a follow-up appointment or reason for calling for a follow-up appointment, should the desired mobility goal not be achieved or specific complaints arise. There is also an automated invitation process so that truly every patient also consistently receives an invitation to complete the questionnaire. The PREMs are used for the learning and improvement cycle. Livit periodically publishes the results to all stakeholders: patients, doctors and colleagues, and other stakeholders. In it, Livit specifically outlines what and how to learn from the PROM measurements. By now, 125,000 clients have been contacted, of which 47,000 have responded. After these clients took receipt of their device, they were asked questions about the wearing comfort, ease of use, esthetics, and the contact with the medical care specialist care during the orthotic device’s fitting process, each time referring back to the purposes of their device. Since 2018, Livit has also been asking its clients questions about the effectiveness of their device, measured in ADL (activities of daily living) gained with the help of their device, through PROMs: patient-reported outcome measures. The response was almost 38%. Livit PROMs are used in the care process. Livit has chosen to also use the PREMs and PROMs in individual patient care, making integration of the PREMs and PROMs in the care process essential. Particularly with regard to alignment with workflow and moments of care. To this end, Livit looked for alignment with its ICT system to link the feedback from the PREMs and PROMs to its client portal, allowing the feedback to be used directly in the care process. This has allowed Livit to respond to the evidence on the value of PREMs and PROMs at micro-level: the communication between patient and healthcare provider improves when the patient’s functioning is measured and then discussed collaboratively with the patient, and doctor, and care provider. Matters that would otherwise go undiscussed are addressed. And this is how PREMs and PROMs make a significant contribution to the patient-centeredness in Livit’s care provision. Sharing the outcome information We are now in 2019 and patients are increasingly partners in care. They also have an increasing role in the improvement of the quality of this care. Medical specialists and referrers also expect feedback on the effectiveness of the chosen solutions. In addition, transparency is a hot topic in healthcare provision. Patients’ opinions and experiences are increasingly used to improve healthcare. When patients rate their own health with a so-called PROM questionnaire, it can lead to better communication with their doctors and healthcare providers. This was shown by an international study by Nivel and the Federaal Kenniscentrum voor de gezondheidszorg (KCE, Healthcare Knowledge Center) in Belgium*. Livit has created a communication plan to share the results for each target group and each purpose. The diagram on the right shows which medium is used to inform each target group. * Bronnen: Nivel; Transparantiemonitor 2018: Transparantie in de zorg verbreed: van informatie over zorgaanbieders naar informatie over effecten van behandelingen, www.nivel.nl Transparantiemonitor van het Nivel, www.nivel.nl www.zorginzicht.nl/, https://www.zorginzicht.nl/kennisbank/ paginas/prom-toolbox.aspx CBS; gezondheidsenquête en https://www.volksgezondheidenzorg.info/ afkortingen Nivel; deelname aan de samenleving van mensen met een beperking, ouderen en de algemene bevolking CBS; https://www.cbs.nl, link naar artikel Zorginstituut Nederland en Nivel, Handreiking voor het meten van kwaliteit van zorg met Patient Reported Outcome Measures Jennifer Kaplan, The Inventor of Customer Satisfaction Surveys Is Sick of Them, Too. June 2016 NPS is door Fred Reichheld geïntroduceerd in 2003 in de Harvard Business Review met het artikel One Number You Need to Grow. Drempelwaarden voor een klinisch relevant verschil, http://www.minerva-ebm. artikel 1, artikel 2 https://www.nivel.nl/nl/publicatie/ het-gebruik-van-patientenuitkomsten- en-ervaringen) Authors: Wouter Akkerman (Director Operational Management Livit), Esther Mik (Director Care and Alliances), Hub van den Boomen (Managing Director Livit Patient Care) and Kim Stoltz (Cluster Director Livit
Since 2016, Livit started a customer satisfaction survey on orthopaedic devices: 265,000 customers have been approached and 100,000 customers have responded.
Scientific research with patient involvement is the new standard
Scope of the research
3 - STUDY DESIGN
Table 3.1: time for demand-led research
Users
Purpose
Patients
Livit believes that information about the effectiveness of care contributes to the choice of treatment or care provider. By sharing this information, we want to offer our (future) clients insight into public information about treatment options and their quality. Insight into health improvements - and mobility improvements in the case of orthopedic devices - and healthcare pathway outcomes is not common practice in this industry. We believe that sharing the results of treatments can help to create the right expectations and therefore contribute to making the right choice for our clients.
Patients and healthcare providers
Outcome information is also very important for use in the consulting room. Especially for a technically oriented field like orthopedic engineering, outcome information helps in conversation and can support and improve communication with the client, especially in creating the right expectations for how the treatment will work. By sharing experiences from other clients, it can help in ‘collaborative decision-making’ because treatment options can be considered jointly to arrive at a suitable choice of treatment. (Based on prognostic information about patients like me) Monitoring: evaluating health and treatment effects over time. Integrating the PROMs into the care process and linking them to the client file makes individual monitoring over time possible. Evaluation of the treatment ans care (and adjusting the treatment plan if needed). Aggregation enables the formulation of statements on the effectiveness of orthopedic devices.
Healthcare providers and insurers
We use the results obtained to further improve our services, and the quality of services and products through our insight into the outcomes. Accountability for performance and quality delivered to health insurers’ policy holders. Another aim is to validate the effectiveness of the use of orthopedic devices on the basis of the research outcomes.
Time for demand-DRIVEN research
Figure 3.1: PROM Toolbox, process steps for implementing PROM
prom cycle process steps
Levels
Examples of PROs
Symptoms
Pain and mobility
Functional status
Performing activities of daily living
Perceived health
Perceived satisfaction
Table 3.2: sharing the outcome information
Purpose of use and communication platform
The results are published on the website www.livit.nl and therefore accessible to both existing and new users. The results are published by topic in the Livit Client Magazine and explained using real-world stories. This magazine is available at livit.nl and the reading tables at Livit locations, as well as various care institutions. The highlights are communicated to followers and fans on social media (Facebook).
Publication of the results by way of white papers on the Livit knowledge and expertise platform for orthopedic care, www.zorgprofessionals.livit.nl, Annual Newsletter to healthcare professionals on the progress of the effectiveness programme for orthopedic devices. Publication of this booklet, which has been distributed among Livit relations, and which has also been made available online, at zorgprofessionals.livit.nl.
Sharing the outcome information
orthopedic corset Improved mobility and reduced pain when wearing a corset for patients with chronic low back pain
RESERACH Scope
Introduction Back problems (dorsopathies) are one of the most common locomotor system conditions. In 2019, almost 600,000 new cases were reported in the Netherlands: 246,400 men and 352,600 women. In addition, over the period of 2011 to 2019, the number of people with symptoms due to degeneration of the intervertebral discs (osteoarthritis / spondylosis of the spinal column) increased by approximately 40%1. This is a collection of conditions with diverse or unknown causes. Back problems are usually categorised as specific and non-specific back complaints. Specific back problems are complaints with an attributable physical cause. Examples of this are a spinal disc herniation, osteoporosis, a fracture or a tumour2. Specific causes for back problems are not identified in most cases. For example, of all cases of acute low back pain, approximately 95% are non-specific. Non-specific low back pain means no specific physical cause can be identified. A commonly used hypothesis is that non-specific low back pain is linked with overloading, for example, the intervertebral discs, joints, nerves, and muscles of the spinal column3. Most people with back problems have non-specific pain4. As yet, it is not possible to categorise non-specific back problems on the basis of the exact location of the pain and/or which type of tissue is affected, such as the muscles, tendons, or joints5. Although it is clear that back problems are often recurrent, international literature usually categorises the complaints by duration6,7: Acute back problems (duration less than 6 weeks) Subacute back problems (duration 6 to 12 weeks) Chronic back problems (duration more than 12 weeks) The ICD-10 (International Statistical Classification of Diseases and Related Health Problems) makes the following distinctions: ankylosing spondylitis (Bechterew’s disease) other inflammatory spondylopathies spondylosis (osteoarthritis of the spinal column) other spondylopathies conditions of the intervertebral discs (including spinal disc herniation) other dorsopathies, not classified elsewhere dorsalgia Back problems lead to pain and reduced functioning8. Important symptoms of non-specific back problems are diffuse, nagging pain and reduced physical functioning (e.g. due to stiffness) when carrying out daily activities. The Global Burden of Disease study shows that of the 359 conditions studied, low back pain is the condition that leads to the most years lived with disability9. The progress of non-specific back complaints seems favourable in many cases. Approximately 50-75% of patients recover (mostly) within 6 weeks. It is estimated that approximately 25–50% of patients develop chronic complaints to a greater or lesser extent (duration of complaints ≥ 12 weeks). The chances of recovery are lower in these patients. Back problems recur more often and more severely in people who have suffered frequent or long-term back problems3,10. IQ Healthcare, Radboud University Medical Centre was commissioned by the ministry of health (VWSS) to assess the quality of 16 guidelines for diagnosis and treatment of low back pain and lumbosacral radicular syndrome using the AGREE II tool, as well as to summarise and critically analyse these guidelines for commonalities and differences in recommendations11. The guidelines comprise 14 guidelines from the Netherlands, including the Dutch Society for Physiotherapy (KNGF) guidelines on low back pain (2013), the Dutch General Practitioners Association (NHG) standard for non-specific low back pain (2017), the Ketenzorgrichtlijn on low back problems (2010), the NVAB guideline on low back problems (2006), the Zorgstandaard Chronische Pijn (2017), the Behandelkader Pijnrevalidatie (2012), theDutch Society for Anesthesiology (NVA) guideline on spinal column-related low back pain (2011), and the Dutch Orthopedic Association(NOV) guideline on instrumented spinal column surgery (2017). Recommendations in first-line and multidisciplinary guidelines largely correspond in terms of diagnosis, risk assessment, and treatment policy. Many guidelines recommend diagnostic triage that distinguishes between non-specific low back pain, lumbosacral radicular syndrome, and specific low back pain. Bed rest is discouraged as a treatment. Recommended medication usually consists of analgesics. In contrast, reassurance, encouraging activity and resumption of work despite possible pain are recommended12. Many guidelines propose a step-by-step approach (KNGF 2013, NHG 2017, KZ 2010, NVAB 2006, ZS 2017, BP 2013, NICE 2016, KCE 2017) whereby more or different care is recommended if pain and limitations persist. If there is no improvement or recovery, remedial therapy supervised by a physiotherapist or remedial therapist is recommended. As the final recommended conservative treatment option, the guidelines recommend multidisciplinary treatment. Recommendations in the guidelines for second-line care are more diverse. In this, the perspective of the professional group using the guidelines plays a role, as well as the limited scientific substantiation for diagnostic and therapeutic actions. The NVA and NOV guidelines do emphasise that patients should have completed a conservative pathway prior to being eligible for second-line treatment. If conservative treatment and even intensive pain rehabilitation offers patients insufficient relief or comfort, these patients have a legitimate care need that could possibly see them turn to pain relief and support from an orthopaedic corset. Incidentally, both the NVA guideline (2011) and the NOV guideline (2017) do not indicate which criteria can be used to determine conservative treatment was unsuccessful. The recommendations of all 16 guidelines for treatment of low back pain in first-line and multidisciplinary guidelines were analysed, including on the use of corsets if conventional therapy did not yield the desired result. Not utilising corsets and lumbar support is not recommended in any of the Dutch guidelines. Recommendations for aftercare were absent in almost all of the analysed guidelines. As self-management, positive health and a multidisciplinary biopsychosocial model are important concepts at present, a focus on aftercare should not be lacking: the advice given to the patient to take home and/or to work? The health of the patient is not just the care provider’s responsibility but also that of the patient. This does mean tools should be offered to quantify treatment expectations. There is little scientific substantiation for the effect of corsets on the daily functioning of patients with low back pain. A Japanese study on the effect of wearing a corset over 6 months showed that the lower back pain was reduced, and no deterioration of muscle strength was found in the paravertebral back muscles13. The aim of this article is to discuss patient-reported outcomes on the use of a corset. This research shows that improvements in activities of daily living (ADL), pain reduction and mobility as perceived by patients are certainly positively stimulated by wearing a corset. Patients and patient organisations are increasingly engaged in improvements to the quality of care. In many cases, patients wish to play a larger part in their own care pathway and make decisions jointly with their care providers. In addition, patients are more often being considered as partners with respect to the care plan, and care professionals apply the customer experience as a starting point in their advice and actions. In order to arrive at reliable information on the quality and the outcomes of the care provided, it must be measured first. One method is to ask patients about the effect of the care/treatment by way of a patient-reported outcome measurement. Every party benefits from transparency in care: the patient, who receives better care, the care provider, who offers more efficient and effective care, and the healthcare insurer, who can validate the effectiveness of the care received. Livit Orthopedie, a Dutch provider of orthopaedic and prosthetic services and products,started a study in 2017 on the effectiveness of corsets with the intention of contributing to insight for patients and care providers into the use of corsets. Method In recent years, there has been an increased focus on placing patients at the centre of health care research and evaluating clinical care in order to improve their experience and ensure that research is both robust and of maximum value for the use of care professionals. Patient-reported outcomes (PROs) provide reports from patients about their own health, quality of life, or functional status associated with the health care or treatment they have received14. This study is limited to people with chronical lower back pain. Between October 2018 and December 2020, 1,782 patients who had been provided with corsets were asked about the effectiveness of the corset 3 weeks after receipt.In all cases, the corset was prescribed to the patients by a medical specialist (physician). To evaluate the short- and longer-term effects, this research was split into a group of first-time users (short-term effect) and a group of repeat users of a corset to assess the longer-term effects.Repeat users were patients who wore the corset over a period of 3 years. The use was validated by acertified prosthetist/orthotist (CPO).The questionnaires were sent by e-mail and were voluntary. All corsets braces were supplied by Livit Orthopedie. The questionnaire contained 10 questions, each with a qualitative ordinal scale in terms of pain perception and daily functioning (deteriorated a lot to improved a lot). Mobility was expressed in metres. Patients were required to indicate mobility with and without the corset. The primary outcome measure was mobility, assessed using an ordinal scale with and without the use of a corset. Secondary outcome measures were pain and general daily functioning. Age and gender were also recorded. Patients provided consent when submitting the questionnaire. The following PROs were defined for this study on the effectiveness of a corset: How has your general daily functioning changed since the use of your corset? How have your pain symptoms changed since the use of your corset? Indicate how mobile you are with/without the corset. The primary outcome measure was mobility, assessed using an ordinal scale with and without the use of a corset. Secondary outcome measures were pain and general daily functioning. With a population size of 8,000 patients per year who are given a corset, and a confidence level of 95%, an error margin of 4% was determined. This expresses the number of random sampling tests in the results of a questionnaire. The results are presented in bar charts, frequency tables and percentage distribution of responses in order to analyse the outcome measures15. Technical information An orthopaedic corset is a customised aid for parts of or the entire spinal column. A corset can have three different functions, defined by the choice of material and the structure of the corset. The corset can either stabilise, correct or immobilise. Within these function groups, there is a distinction in the stiffness of the corset in the way materials are used. Taking this into consideration, the table below describes a type of corset for the different medical conditions listed. The aim of the corset is to ensure general daily activities are less painful or easier to carry out, with the patient’s care need as the key focus. The orthopaedic corset can be supplied in various versions and materials. It may be that a standard corset is sufficient. If this is not the case, a corset can be made to measure. Stepped care The principle of stepped care is an important starting point in general, and certainly as part of specialist medical rehabilitation care too. This principle is referred to by the Healthcare Institute Netherlands (ZiNL) in the Algemene Beroepskader Revalidatiegeneeskunde van de Nederlandse Vereniging van Revalidatieartsen (VRA) (the General Professional Framework for Rehabilitation Medicine by the Dutch Association of Rehabilitation Physicians)16, the memorandum on Indicatiestelling Medisch Specialistische Revalidatie (Specialist Medical Rehabilitation Care Assessment) by the VRA17, and the VRA position paper 201518. Stepped care is a step-by-step plan of increasingly intensive types of care, whereby the aim is not to carry out every step but rather to achieve results with as few steps as possible. The stepped care principle means as gently as possible and as intensively as possible. As such, the medical specialist will recommend the most purposeful treatment possible in view of the nature and severity of the issues. The stepped care principle works on the premise that the treatment offered is always the most purposeful. This involves an effective treatment that is the least demanding and the cheapest and that suits the nature and severity of the issues. A more intensive intervention is sought only when less intensive intervention yields insufficient results17. It is not until treatment, by way of a less complex solution (for example a ready-made corset), has yielded insufficient results or will not yield sufficient results that will it be appropriate for the patient to receive treatment using a customised solution prescribed by a medical specialist. All corsets in this study complied with the requirements for stepped care. Results The response rate of this outcome study was 38%; 677 of the 1782 patients completed the questionnaire. All responses were suitable for use. The response rates of online questionnaires varied widely, depending on target group and the nature of the study. The average response rate for e-mail questionnaires fluctuated between 25% and 33%19. Table 1 shows the demographic data of the research population. Of the respondents, 39% were between 30 and 70 years of age, and 61% were 70 years of age or over. The majority of the respondents in this study (63%) were women. Patients have been diagnosed with chronic a-specific low back pain by a medical physician. Patients experienced hardly any improvement in the complaints and experienced increasingly functional limitations, frequent treatments have been without effect, avoidance behaviour occurred and social interaction becomes limited. The responses are presented below. How has your general functioning changed since the use of your corset? Of the respondents, 67% indicated that their general daily functioning improved with the use of an orthopaedic corset; 29% indicated it had much improved and 5% even indicated it had improved by a lot. There is a slight difference between the perceived improvement of patients with a ready-made corset and those with a customised corset; the difference occurred in those patients who indicated that the functioning improved a little and those who indicated it improved a lot. Of the patients with a customised corset, 33% indicated that with use, functioning improved a lot; the comparable percentage was 22% for the group with a ready-made corset. Of the group that indicated functioning had improved a little, 41% had ready-made corsets and 30% had customised corsets. For patients who started using a corset for the first time or those who were given a repeat aid, the perceived positive effect was virtually equal at 68%. However, the perceived effect in patients with a repeat aid was higher, as a larger number indicated that functioning improved by a lot (35% versus 23%) How have your pain symptoms changed since the use of your corset? The study shows that the pain was reduced and the strain on the back lessened. Figure 2 is a graphic representation showing that the group with a corset had a 59% improvement in pain symptoms. Within this group, virtually no difference in pain reduction was detected between patients who were new to wearing a corset and those who were using a repeat aid. There was an 8% difference between patients with a ready-made corset (55%) and those with a customised corset (63%) who indicated their pain was reduced. Indicate how mobile you are with and without your corset Mobility improved significantly: the group who were able to walk only at home was reduced by 67%, the group who were able to walk to the local shop increased by 72%, and the group who were once again able to go for a long walk actually doubled (Figure 3). With this, the mode shifted across three classes, from ‘I am only able to walk around my home’ (30%) to ‘I am able to walk to the local shop’ (31%). Tables 2 and 3 show the perceived mobility with and without a corset in patients with a ready-made or customised corset and for a first or repeat aid. The perceived mobility improvement for patients with a customised corset was higher than with a ready-made corset. In the higher mobility classes, the changes observed were actually twice as high for those with a customised corset (108%) as they were for those with a ready-made corset (43%). Patients with a repeat aid experience significantly improved mobility gains compared to patients who started wearing the corset for the first time. The mode in the patient group with a first aid improved by one mobility class when wearing a corset as opposed to three mobility classes for the patient group with a repeat aid. The change in the group of higher mobility classes was also twice as big (Table 3). Discussion: Analysis of guidelines for low back pain largely correspond in terms of recommendation to first-line and multidisciplinary guidelines on diagnosis, risk assessment, and treatment policy. Many guidelines recommend a diagnostic triage, and bed rest is discouraged as a treatment. Recommendations include encouraging activity and resumption of work despite possible pain20. Mobility is always more beneficial for recovery than trying to avoid movement that causes back stiffness and only serves to increase the pain. This study supports the use of a corset as an effective alternative treatment therapy for pain reduction when other therapy has not yielded the desired results. The effect on the reduced pain perception by patients was high at 59% and directly contributed to the regained daily functionality that was reported by 67% of patients. The study by IQ Healthcare recommends focusing future care policy on a strong first line and collaboration between the various disciplines11. It is recommended that the outcomes of the effectiveness of the various conservative treatment methods should be included in the new multidisciplinary guideline. Insights into the effectiveness of treatment methods of different disciplines should render the care process for patients more effective. Patients with a repeat aid experience had significantly improved mobility gains compared to patients who started wearing the corset for the first time. The mode in the patient group with a first aid improved one mobility class when wearing a corset as opposed to three mobility classes for the patient group with a repeat aid. This demonstrates that wearing a corset in the long term yields a perceived positive effect and as such, proves to be an effective therapy. Follow-up research into the duration of corset use could provide additional insight into these findings. Low back pain often has a degenerative course. As far as we are aware, very limited research has been done into the use of a corset in the long term. A difference was identified between the use of a customised corset and a ready-made corset. The perceived mobility improvement for patients with a customised corset was higher than with a ready-made corset. In the higher mobility classes, the changes observed were actually twice as high for those with a customised corset (+108%) as they were for those with a ready-made corset (+43%). This challenges care professionals to take a closer look at the stepped care principle and to realise that the aim of this principle is not to follow every step but rather to achieve results with as few steps as possible. The results of this study give rise to the hypothesis that care professionals often follow the entire step-by-step plan. The default prescription is more often a ready-made corset, followed by a customised corset if the intended goal has not been reached, and there is a reluctance to shorten the step-by-step plan and move to a customised corset straight away. It would be interesting to carry out follow-up research into patients with ready-made corsets who experience fewer effects to refine the diagnostic process and shorten the stepped care process. A limitation of this study is that no information was available on deformities of the lower back. These could have an impact on the effect of the corset. Unlike common opinion in practice, research shows that wearing a corset brace does not have a negative effect on muscle strength, muscle endurance, and muscle and tendon stiffness12,13. This study supports this finding and shows that the use of an orthopaedic corset can clearly yield improved mobility. The group who are able to walk only at home was reduced by 67%, the group who were able to walk to the local shop increased by 72%, and the group who were once again able to go for a long walk actually doubled. The improvement of mobility is the objective of all guidelines for low back pain11, and the use of an orthopaedic corset is a proven effective aid in this respect. Conclusion The results of this large-scale PROM study on the effectiveness of wearing an orthopaedic corset shows that its use contributes to the reduction of pain and therefore improvements in general daily functioning and mobility. Reduced complaints mean that patients can move more easily with less pain and improve their quality of life. This study shows that the use of an orthopaedic corset seems to serve as a suitable support, reducing complaints and offering freedom of movement. We hope this study contributes to the insight into the expected effect of an orthopaedic corset for low back pain that can be used by professionals in the management of patients’ expectations in daily practice. References Volksgezondheid en Zorg Info. Nek- en rugklachten.Published 2022. Accessed March 1, 2022. https://www.volksgezondheidenzorg.i nfo/onderwerp/nek-en-rugklachten /cijfers-context/ huidige-situatie#node-nieuwe- gevallen-nek-en-rugklachten- huisartsenpraktijk Pillastrini P,GardenghiI, Bonetti F, et al. An updated overview of clinical guidelines for chronic low back pain management in primary care.Joint Bone Spine. 2012;79(2):176-185. doi:10.1016/j.jbspin.2011.03.019 Bons S, Borg M, van den Donk M, et al.NHG-Standaard Aspecifieke Lagerugpijn (M54).; 2017. van Tulder M,KoesBW.Evidence-Based Handelen Bij Lage Rugpijn: Epidemiologie, Preventie, Diagnostiek, Behandeling En Richtlijnen.2nd ed. Bohn Stafleu van Loghum; 2013. Oliveira CB, Maher CG, Pinto RZ, et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview.European Spine Journal. 2018;27(11):2791-2803. doi:10.1007/s00586-018-5673-2 Koes BW, van Tulder M, Lin CWC, Macedo LG, McAuley J, Maher C. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care.Eur Spine J. 2010;19(12):2075-2094. doi:10.1007/s00586-010-1502-y Koes BW, vanTulderMW, Ostelo R, Kim Burton A, Waddell G. Clinical Guidelines for the Management of Low Back Pain in Primary Care.Spine (Phila Pa 1976). 2001;26(22):2504-2513. doi:10.1097/00007632-200111150-00022 Buchbinder R, van Tulder M, Öberg B, et al.Low back pain: a call for action.The Lancet. 2018;391(10137):2384-2388. doi:10.1016/S0140-6736(18)30488-4 Tichenor M, Sridhar D. Metric partnerships: global burden of disease estimates within the World Bank, the WorldHealthOrganisation and the Institute for Health Metrics and Evaluation.Wellcome Open Res. 2019;4:35. doi:10.12688/wellcomeopenres.15011.2 Downie A, Williams CM, Henschke N, et al. Red flags to screen for malignancy and fracture in patients with low back pain: systematic review.BMJ. 2013;347(dec11 1):f7095-f7095. doi:10.1136/bmj.f7095 Brouwers MC, Kho ME, Browman GP, et al.AGREE II: advancing guideline development, reporting and evaluation inhealthcare.Canadian Medical Association Journal. 2010;182(18):E839-E842. doi:10.1503/cmaj.090449 Foster NE, Anema JR, Cherkin D, et al.Prevention and treatment of low back pain: evidence, challenges, andpromisingdirections.The Lancet. 2018;391(10137):2368-2383. doi:10.1016/S0140-6736(18)30489-6 Sato N, Sekiguchi M, Kikuchi S, Shishido H, Sato K, Konno S. Effects of long-term corset wearing on chronic low back pain. Fukushima Journal of Medical Science. 2012;58(1):60-65. doi:10.5387/fms.58.60 14.Zorginstuut Nederland. PROM-toolbox: PROM-wijzer en PROM-cyclus.Published 2021. Accessed April 9, 2022. https://www.zorginzicht.nl/ ondersteuning/prom-toolbox-prom- wijzer-en-prom-cyclus Weldring T, Smith SMS. Article Commentary: Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs).Health Services Insights. 2013;6:HSI.S11093. doi:10.4137/HSI.S11093 NederlandseVerenigingvan Revalidatieartsen (VRA).Algemene Beroepskader Revalidatiegeneeskunde.; 2016. NederlandseVerenigingvan Revalidatieartsen (VRA).Indicatiestelling Medisch Specialistische Revalidatie.; 2016. Nederlandse Vereniging van Revalidatieartsen (VRA).Position Paper Revalidatiegeneeskunde.; 2015. QuestionPro. Good Survey Response Rate. Published December 21, 2021. Accessed April 9, 2022. https://www.questionpro.com/blog/ good-survey-response-rate/ de Oliveira Silva D, Pazzinatto MF, Crossley KM, Azevedo FM, Barton CJ. Novel Stepped Care Approach to Provide Education and Exercise Therapy for Patellofemoral Pain: Feasibility Study.Journal of Medical Internet Research. 2020;22(7):e18584. doi:10.2196/18584 Authors: Tim Dries,MSc, Product Manager Livit Orthopedie, Dordrecht, Netherlands Jan Willem Van der Windt, MSc, Livit Orthopedie, Amsterdam Wouter Akkerman,CPO, Director Livit Orthopedie, Amsterdam, Netherlands Leen Nugteren,CPO, Livit Orthoepdie, Rotterdam, Netherlands Marco Toor,CPO, Li vit Orthopedie, Den Haag, Netherlands Bram Hentenaar, Orthopaedic Surgeon at Diakonessenhuis, Utrecht, Netherlands
There is little scientific substantiation for the effect of corsets on the daily functioning of patients with low back pain. The aim of this manuscript is to discuss patient-reported outcomes on the use of a corset. This research shows that improvements in activities of daily living (ADL), pain reduction and mobility as perceived by patients are certainly positively stimulated by wearing a corset. Back problems lead to pain and reduced functioning. Important symptoms of non-specific back problems are diffuse, nagging pain and reduced physical functioning (e.g. due to stiffness) when carrying out daily activities. The Global Burden of Disease study shows that of the 359 conditions studied, low back pain is the condition that leads to the most years lived with disability.
This study is limited to people with chronical lower back pain. From 2018 till 2020, 1,782 patients were asked for feedback The response was 38% The corset was prescribed by a medical specialist (physician).
67% of respondents indicated that their general daily functioning improved with the use of an orthopaedic corset!
4 - ORTHOPEDIC CORSET
Total
Fem.
Male
N
677
428
249
63%
37%
Age
< 30
1%
0%
30-60
16%
13%
17%
60-70
23%
28%
20%
70-80
43%
34%
>80
24%
29%
Average age in years
72,1
71,7
71,0
New patiënts
67%
Repeatusers
33%
Confection
32%
Custommade
68%
Figure 4.1: Responses to the question ‘how has your general daily functioning changed since the use of your orthosis?’
Figure 4.2: Response to the question ‘how have your pain symptoms changed since the use of your orthosis/corset?’
Table 1. Demographic information of the research population
Table 2. Response to the questions ‘have you noticed an improvement’ specified into type of aid and medical indication
Figure 3. Response to the question ‘indicate how mobile you are without/with orthosis/corset?'
Mobilityclass
(a) walk in the house (0-10 mtrs)
(b) walk to the neighbors (10-50 meters)
(c) walk to the corner of the street (50-200)
Mobilitywithoutcorset
30%
15%
22%
Mobilitywithcorset
10%
12%
19%
18%
25%
11%
9%
35%
CustomMade
36%
14%
21%
7%
6%
Newpatient
Mobility withoutcorset
26%
Repeatuser
(d)I can go to the store etc. Walk nearby (200-1k)
(e) take a long walk at a stretch (1k-5k)
(f) no mobility restriction (>5km)
8%
31%
Table 3. Mobility improvement for low and high mobility classes (combined)
Low mobilityclasses
Mobility without corset
(a) 0-10 meter
(b) 10 – 50 meter
(a+b) Total
45%
50%
-54%
-38%
51%
-53%
Mobility with corset
Change
(c) 0-10 meter
(d) 10 - 50 meter
(c+d) Total
%
-51%
-47%
High mobility classes
(e) 0-10 meter
(f) 10 – 50 meter
(e+f) Total
27%
108%
47%
114%
(g) 0-10 meter
(h) 10 - 50 meter
(g+h) Total
87%
64% of the respondents indicated an improvement in daily functioning after starting using a knee brace.
Introduction Ostheoarthritis (OA) is one of the most common chronic conditions leading to disability among the elderly (60+ years old)(1–5). Knee OA has a significant impact on daily functioning. Pain, stiffness, reduced strength, changes in posture, and reduced knee stability may cause reduced mobility(6). Usually, a stepped care treatment plan is implemented, whereby more complex treatments, e.g. surgical interventions, are only considered when lesser complex treatments are found unsuitable. According to the Osteoarthritis Research Society International (OARSI) and National Institute for Health and Care Excellence (NICE) guidelines, conservative management comprises a combination of education for self-management, exercise therapy (aerobic and strength exercise), weight management, knee braces, and pain medication. According to the Dutch national FMS guidelines, avalgus knee brace is prescribed for patients with symptomatic medial tibiofemoral OA, where the effectiveness of other conservative management options has been proven to be insufficient.A valgus knee brace is aimed to postpone joint replacement surgery for as long as possible, especially in relatively young and active patients(6). Several systematic reviews have been published on quantifying the effectiveness of the unloader braces in improving clinical outcomes and mechanical leverage(6–8).However, to the best of our knowledge, there is a significant research gap in perception-based studies in understanding the short- and long-term consequences of these braces on the tissues in the knee joint, including the cartilage and ligaments.Currently performed perception-based studies are based on relatively small population sizes(9–11), and further research can advance the understanding of the effects of unloader braces experienced by patients with OA. The presented perception-based evaluation study aims to evaluate the short- and long-term effects of a (semi-)rigid knee brace in patients with knee OA. Methods Measurement of the perception-based outcome from patients is a method to measure health outcomes and quality of life and provide insight into the value of patient care(12,13). For this study, the Patient Reported Outcome Measurement (PROM) toolbox of the Netherlands Healthcare Institute and the Netherlands Federation of University Medical Centres (NFU) guidelines for the selection of PROs and PROMs were used(14–16).An illness or condition often causes complaints and symptoms, such as pain, that relate to problems with daily functioning. Retrospective measurements provide insight into the effect a treatment has on the patient’s perceived health in terms of their physical well-being and/or functioning.In this study, subjects were questioned about symptoms, functional status, and perceived health. The following PROs were defined to determine the effectiveness of the knee braces: How has your general daily functioning changed since using your knee brace? How have your pain symptoms changed since using your knee brace? Please indicate how mobile you are with/without the knee brace? Information about health prior to and after an intervention is needed to improve the effectiveness of a knee brace. This study compared feedback from patients about function gained with and without a (semi-)rigid knee brace. There are no standard or target values that could be used in the study, as there are no comparable studies regarding the effectiveness of these orthopedic aids. The PROM questions in the study were prepared based on the usual questionnaires familiar in orthopedics (surgery), thus, adhering to scientifically accepted and validated PROM questions(13,17). Between October 2018 and December 2020, 1.003 patients with OA that were provided with a knee brace (both new users and repeat users) were asked to complete a questionnaire about the effectiveness of the brace after wearing it for 3 weeks. Patients received their knee brace from a qualified certified prosthetist/orthotist (CPO) and were mostly referred to the CPO by medical doctors. The questionnaires were sent by e-mail, and it was mentioned that responding to this questionnaire was voluntary. Additionally, informed consent was given. The questionnaire contained questions related to pain perception and daily functioning, each with a qualitative ordinal scale (7-point scale ranging from ‘very deteriorated’ to ‘improved significantly’). Using these questions, patients were encouraged to compare their pain perception and daily functioning at the time of the survey with their perceived perception and functioning 3 weeks earlier. Mobility was expressed in meters. The primary outcome measure was mobility assessed with and without using the (semi-)rigid knee brace. Secondary outcome measures were pain symptoms and overall daily functioning assessed by the 7-point ordinal scale. Age and sex were also documented. Descriptive statistics was used as basic measures to describe the survey data. They consist of summary descriptions of frequency and percentage response distributions, and mode was used to measure the central tendency(18). With a population size of 4025 patients provided with a rigid-knee brace in the Netherlands in the study period and a confidence level of 95%, a margin of error of 5% was calculated. This expresses the amount of random sampling error in the results of this survey. OA diagnosis A was confirmed by a medical doctor (MD) for all patients. The diagnosis was mostly made based on X-rays and/or magnetic resonance imaging (MRI). Patients throughout the Netherlands in various institutions, ranging from university hospitals and rehabilitation centers to nursing homes, were qualified eligible for this study when the MD recommended the use of a knee brace. Provided braces from different manufacturers were all selected on their unloading capabilities and supplied to the patient by a qualified CPO. Technical information For this study, patients with OA were randomly allocated to treatment with a conventional rigid-knee brace (Agillium Reactive® from Ottobock and the Defiance® from DJO) (Fig. 1). Both braces were selected on their unloading capabilities and were supplied to the patient by a qualified CPO. Results The response rate of this outcome study was 38%: 381 out of 1003 patients completed the questionnaire. All responses were analyzed and included as acceptable data in this study. Online survey response rates vary greatly depending on the target audience and the nature of the research. The mean response rate for e-mail surveys fluctuates between 25% and 33%(19). Table 1 demonstrates the descriptive characteristics of the study population.In total, 63% of the respondents were aged 60 years or older, and 30% were aged 70 years or older.This age range also matches the greatest prevalence and incidence rates of OA, where the majority of people older than 55 years has radiological features of OA(20). The majority of the respondents (60%) in this study was women. The results are presented separately for each question asked in the questionnaire. Figure 2 shows the results regarding the mobility change for all respondents in this study.Mobility while using a knee brace improved considerably in different mobility groups. Mobility in the group limited to the home environment was reduced by 74%, mobility in the group being able to walk to a nearby shop was increased by 50%, and mobility in the group of respondents experiencing no mobility restrictions was increased from 3% to 13% while using a knee brace. A total of42% of the respondents using a knee brace indicated that they could take a long walk again (18%) or go to the shop in the area (24%). Together with the 13% of patients experiencing no mobility restrictions when using a knee brace, this indicates a total growth of 80% for these mobility classes. Only 9% of patients were limited to their own living environment. Figure 3 shows the results for the reduction of pain symptoms.The group wearing a knee brace showed an improvement (reduction) of pain symptoms of 54%. 29% of the respondents reported that their pain symptoms were reduced significantly or very significantly, in contrast to 36% of the respondents who experienced no change. A small change was noted between new users and repeat users, where new users showed more improvement and less deterioration (3% for new users and 16% for repeat users). Figure 4 shows the results for change in overall daily functioning while using a knee brace. Sixty-two percent of respondents indicated that their general daily functioning improved after they started using a knee brace, 29% of respondents indicated that it improved significantly, and 7% of respondents even stated it improved very significantly. There was a small difference between the improvement of patients that started using a knee brace and patients that continued the treatment with a knee brace. Nine percent of respondents stated that the functioning deteriorated after using the knee brace. Table 2 shows the mobility results for both new and repeat users with or without using a knee brace. In the low mobility class (class a), a difference of 60% was reported between repeat users (39% of the respondents could walk 0–10 meters) and new users (24% of the respondents could walk 0–10 meters). Furthermore, it was noted that the highest mobility class was 2.8 times bigger for repeat users (class f is 17%) than for new users (class f is 6%). It can be concluded that the distribution of results is more skewed towards the extreme mobility classes (low and high) for repeat users than for new users. Table 3 compares a combination of mobility classes with and without a knee brace. If the low mobility classes are combined, we noted the skewness of repeat users compared to new users (without a knee brace), as 45% of respondents of repeat users fall in the lowest mobility class compared to 30% for new users. Nonetheless, the decrease in these classes was approximately the same for both patient groups (repeat and new) after using a knee brace: -60% for new users and -64% for repeat users. However, for the high mobility classes, a different outcome was noticed as the change in the high mobility class was higher for new users (+192%) than for repeat users (+43%). Discussion In this study, the short- and long-term effects of a (semi-)rigid knee brace in patients with knee OA were measured using a perception-based evaluation. The results showed that 64% of the respondents indicated an improvement in daily functioning after starting using a knee brace. In a previous study comparing a braced patient group with a control group, where patients only received conservative management without knee bracing, the patient group reported an improvement of 50%, whereas the control group reported an improvement of 36%(21). The current study showed a 14% stronger effect based on a bigger population. Gained mobility The results of this study support the findings of the PROM study by Briggs et al. (2012)(7), which showeda significant improvement in quality of life (SF-12) (p < 0.05) and pain, stiffness, and function (WOMAC) (p < 0.05) while using a brace, based on a study on 39 patients. The bigger population size of this study strengthens these findings; braces, specifically designed to unload the degenerative compartment of the knee, can be an effective treatment to decrease pain and maintain activity level. This study builds on earlierperception-based studies in specifying the improved quality of life in gained mobility among mobility classes(22,23). Whilst using a knee brace, 60% of the respondents indicated that they could take a long walk again (19%) or go to the shop in the area (28%), and 13% of the respondents experienced no mobility restrictions anymore. The use of the knee brace increased mobility by 70%in these 3 groups combined. Furthermore, a 69% reduction was shown in patients limited to their own living environment when comparing the group using a knee brace (9% of the respondents) with the group without using a knee brace (29% of the respondents). In the scope of this study, no previous research on the effect of knee bracing in different mobility classes has been found, highlighting its novelty. Pain reduction As shown in this study, pain symptoms are reduced when using a knee brace. This finding is supported by previous studies, where Briggs et al. have reported a significant improvement in pain and function(7).They have also shown that most knee braces users (69%) found pain relief to be a very important reason to keep using the brace. This is supported by Kiel and Kaiser, showing that knee bracing resulted in a broader medial joint space when walking(24), while the medial joint space itself is presented as a major contributor to perceived pain symptoms. The results of this study particularize the relief in pain obtained by knee braces to animprovement in self-reported pain symptoms of 54% of the respondents after using a knee brace. Thirty percent of the respondents reported that their pain symptoms changed significantly to very significantly. Briggs et al. have also shown that it is expected that the reduced pain experience contributes to having confidence in the knee and consequently improving the ability to maintain general health(7). The course of limitations in mobility over time This study showed that the mobility level for patients with knee braces in the mobility range beyond 50 meters was high, with, on average, 85% of the respondents indicating a high level of mobility using the knee brace. When comparing new users (88%) with repeat users (84%), no significant difference was found. These results support the findings of Van Dijk et al. and Pisters et al., who have shown that limitations in activities seemed fairly stable during the first 3 years of follow-up(25,26). However, the self-reported limitation in mobility without using a knee brace was reported to be increased in the group of repeat users. Only 24% of the new users reported a highly limited mobility level (only being able to move within the living environment) compared to 39% in the repeat users group (an increase of 60%). Self-reported mobility gain with a knee brace in the mobility range beyond 50 meters was shown to improve in 26% of the new users and 53% of the repeat users. These results support the findings of Holla et al.(27), showing that activity limitations slightly decreased after 2 years of follow-up. Concerns to consider Perception-based methods assess pain, function, and quality of life, which are the qualitative markers of disease progression. The quality depends on the disease condition, mood, physical activities, and ultimately the score provided by patients. Although these methods are well accepted by clinicians, it is impossible to quantify the morphological and biomechanical changes in the soft tissue regions with these methods. Therefore, it is important to assume the predicting value for the long- and short-term effects on the overall physical activity of the subject with caution. Many patients compensate for the knee instability by more muscle activation (co-contraction) around the knee joint. This provides a stable feeling but also has a progressive effect on knee OA due to the increased pressure on the knee joint.Studies have shown that wearing a stabilizing rigid knee brace ensures a reduction of muscle co-contraction and pain(28). With a reported pain reduction of 54%, it isfeasible that users wearing knee braces in this study used less co-contraction; This might indicate a reduced the progression of knee OA. Further research is needed to confirm this finding. In this study, the use of pain medications was not assessed, while using analgesics could have influenced the presented results. Although it is expected that only a few patients use pain medication when using knee braces, further research can focus on this combination to investigate the overall pain reduction. Additionally, 9% of the patients did not experience any improvements when using a knee brace or even experienced deterioration. While several aspects, such as correct knee brace fitting, over-compensation of muscles, or additional injuries, could play a role in this, further research is required to understand these outcomes. Conclusion The results of this large-scale PROM study on the effectiveness of (semi-)rigid knee braces in OA patients show that the use of a knee brace contributes to general daily functioning, reduces pain, and increases the possibilities for daily activities. For OA patients, reduced pain eases moving out of their home environment, resulting in a more active life and an improvement in quality of life. This study shows that the use of a knee brace appears to serve as suitable joint support, offering pain relief and freedom of mobility. References: Gohal C, Shanmugaraj A, Tate P, Horner NS, Bedi A, Adili A, et al. Effectiveness of Valgus Offloading Knee Braces in the Treatment of Medial Compartment Knee Osteoarthritis: A Systematic Review. Sports Health: A Multidisciplinary Approach 2018;10:500–514. Fitzgerald GK, Piva SR, Irrgang JJ.Reports of joint instability in knee osteoarthritis: Its prevalence and relationship to physical function. Arthritis Care & Research 2004;51:941–946. Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis and Cartilage 2013;21:1145–1153. McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, et al.OARSI guidelines for thenon-surgical management of knee osteoarthritis. Osteoarthritis and Cartilage 2014;22:363–388. Jeong HS, Lee SC, Jee H, Song JB, Chang HS, Lee SY. Proprioceptive Training and Outcomes of Patients With Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Journal of Athletic Training 2019;54:418–428. Richtlijnendatabase - Federatie Medisch Specialisten. Conservatieve behandeling van artrose in heup of knie [Internet].[cited 2022 Mar 1];Available from: https://richtlijnendatabase.nl/richtlijn/ artrose_in_heup_of_knie/ Briggs K, Matheny L, Steadman J. Improvement in Quality of Life with Use of an Unloader Knee Brace in Active Patients with OA: A Prospective Cohort Study. Journal of Knee Surgery 2012;25:417–422. Thoumie P, Marty M, Avouac B, Pallez A, Vaumousse A, Pipet LPT, et al. Effect of unloading brace treatment on pain and function in patients with symptomatic knee osteoarthritis: the ROTOR randomized clinical trial. Scientific Reports 2018;8:10519. Duivenvoorden T, Brouwer RW, van Raaij TM, Verhagen AP, Verhaar JA, Bierma-Zeinstra SM.Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database of Systematic Reviews 2015; Ostrander R v, Leddon CE, Hackel JG, O’Grady CP, Roth CA. Efficacy of Unloader Bracing in Reducing Symptoms of Knee Osteoarthritis. Am J Orthop (Belle Mead NJ) 45:306–311. Richard Steadman J, BriggsKK, Pomeroy SM, Wijdicks CA. Current state of unloading braces for knee osteoarthritis. Knee Surgery, Sports Traumatology, Arthroscopy 2016;24:42–50. Smith AJ, Lloyd DG, Wood DJ. Pre-surgery knee joint loading patterns during walking predict the presence andseverity of anterior knee pain after total knee arthroplasty. Journal of Orthopaedic Research 2004;22:260–266. Weldring T, Smith SMS. Article Commentary: Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Services Insights 2013;6:HSI.S11093. Zorginstuut Nederland. PROM-toolbox: PROM-wijzer en PROM-cyclus [Internet].2021 [cited 2022 Apr 9];Available from: https://www.zorginzicht.nl/ondersteuning/ prom-toolbox-prom-wijzer-en-prom-cyclus Zorginzicht. PROM Toolbox (Summary in English) [Internet]. 2021 [cited 2022 Mar 15];Available from: https://www.zorginzicht.nl/ ondersteuning/prom-toolbox-summary Terwee CB, van der Wees PJ, Beurskens S. Handreiking voor de selectie van PROs en PROMs.2015. Parween R, Shriram D, Mohan RE, Lee YHD, Subburaj K. Methods for evaluating effects of unloader knee braces on joint health: a review. Biomed Eng Lett 2019;9:153–168. O’Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for Reporting Qualitative Research. Academic Medicine 2014;89:1245–1251. QuestionPro. Good SurveyResponse Rate [Internet]. 2021 [cited 2022 Apr 9];Available from: https://www.questionpro.com/blog/ good-survey-response-rate/ Nivel Zorgregistraties. Artrose - Prevalentie en aantal nieuwe gevallen van artrose -huisartsenpraktijk [Internet].[cited 2022 Mar 1];Available from: https://www.vzinfo.nl/artrose/ leeftijd-en-geslacht Nagai K, Yang S, Fu FH, Anderst W. Unloader knee brace increases medial compartment joint space during gait in knee osteoarthritis patients. Knee Surgery, Sports Traumatology, Arthroscopy 2019;27:2354–2360. Petersen W, Ellermann A, Zantop T, Rembitzki IV, Semsch H, Liebau C, et al.Biomechanical effect ofunloader braces for medial osteoarthritis of the knee: a systematic review (CRD 42015026136). Archives of Orthopaedic and Trauma Surgery 2016;136:649–656. Petersen W, Ellermann A, Henning J, Nehrer S, Rembitzki IV, Fritz J, et al. Non-operative treatment of unicompartmental osteoarthritis of the knee: a prospective randomized trial with two different braces—ankle–foot orthosis versus knee unloader brace. Archives of Orthopaedic and Trauma Surgery 2019;139:155–166. Kiel J, Kaiser K. Patellofemoral Arthritis. 2022. van Dijk GM, Veenhof C, Spreeuwenberg P, Coene N, Burger BJ, van Schaardenburg D, et al.Prognosis of Limitations in Activities in Osteoarthritis of the Hip or Knee: A 3-Year Cohort Study. Archives of Physical Medicine and Rehabilitation 2010;91:58–66. Pisters MF, Veenhof C, van Dijk GM, Heymans MW, Twisk JWR, Dekker J. The course of limitations in activities over 5 years in patients with knee and hip osteoarthritis with moderate functional limitations: risk factors for future functional decline. Osteoarthritis and Cartilage 2012;20:503–510. Holla JFM, Steultjens MPM, Roorda LD, Heymans MW, ten Wolde S, Dekker J. Prognostic factors for the two-year courseof activity limitations in early osteoarthritis of the hip and/or knee. Arthritis Care & Research 2010;62:1415–1425. Fantini Pagani CH, Willwacher S, Kleis B, Brüggemann GP.Influence of a valgus knee brace on muscleactivationand co-contraction in patients with medial knee osteoarthritis. Journal of Electromyography and Kinesiology 2013;23:490–500. Authors: Tim Dries, MSc, Product Manager Livit Orthopedie, Dordrecht, Netherlands Jan Willem Van der Windt, MSc, CEO Livit Orthopedie, Amsterdam, Netherlands Wouter Akkerman, CPO, Director Livit Orthopedie, Amsterdam, Netherlands Mari Kluijtmans, CPO, Livit Orthopedie, Eindhoven, Netherlands Rob P.A. Janssen, Medical Doctor (MD PhD);(1) Department of Orthopaedic Surgery & Trauma, Máxima Medical Center, Eindhoven-Veldhoven, The Netherlands; (2) Orthopaedic Biomechanics, Department of Biomedical Engineering, Eindhoven University of Technology, The Netherlands; (3) Value-Based Health Care, Department of Paramedical Sciences, Fontys University of Applied Sciences, Eindhoven, The Netherlands
This study is limited to people with knee osteoarthritis. The response rate of this outcome study was 38%: 381 out of 1003 patients completed the questionnaire. The knee brace was prescribed by a medical specialist (physician).
This study of patient-reported outcome measures regarding the use of stabilizing knee braces for knee osteoarthritis provides insight into the additional care and quality of life provided by the use of these orthopaedic aids. The aims of this study are to measure the effectiveness of knee braces in daily life and to validate the efficacy of using orthopeadic medical aids. In the study, 381 patients with knee Osteoarthritis were provided with knee braces and were asked about the effectiveness of the braces 3 weeks after they first started wearing them. This large-scale study found that the use of knee braces contributed to user-mobility, reduced pain, and increased the possibility to perform daily activities. Knee braces appear to serve as a suitable support for knee joints, providing pain relief and freedom of movement, and should be considered a useful non-surgical treatment method for knee Osteoarthritis.
knee brace Improved mobility and reduced pain when wearing a (semi-)rigid knee brace for individuals with knee osteoarthritis.
Scope of the study
Figure 1: Types of knee-braces used in this research; Agillium Reactive® from Ottobock on the left, Defiance® from DJO on the right
5 - (SEMI-)RIGID KNEE BRACE
5 - (semi-)rigid knee brace
(semi-) rigid knee braces illustration
Figure 3: Results for the question: How have your pain symptoms changed since using your knee brace?
Figure 2: Results for the question: Please indicate how mobile you are with/without the knee brace? (OA indication)
Table 1: descriptive characteristics of the study population
Female
381
227
154
60%
40%
Age groups
3%
2%
Age mean in years
64,9
65,0
New users
Repeat users
Figure 4: Results for the question: How has your overall daily functioning changed since using your knee brace?
Mobility Classes
(a) -I can walk in the house (0 - 10 meters)
(b)- I can walk to the neighbors (10 - 50 meters)
(c)- I can walk to the corner of the street (50 - 200 meters)
All users
Mobility without a knee brace
Mobility with a knee brace
39%
4%
5%
(d)- I can walk to the store etc. Nearby (200 - 1000 meters)
(e)- I can take a long walk continuously (1000 - 5000 meters)
(f)- I no longer have a mobility restriction in terms of distance (> 5km)
Table 2: Results for the question: Please indicate how mobile you are with/without the knee brace? (split between new and repeat users)
Low mobility classes
Mobility without knee brace
-64%
Mobility with knee brace
-62%
-60%
Table 3: Mobility improvement for low and high mobility classes combined
(e) 1-5 km
(f) no restriction
(g) 1-5 km
(h) no restriction
82%
192%
silicone wHO; Reduced pain and improved daily activities for individuals with Hand osteoarthritis using a silicone wrist hand orthosis (SWHO)
This study is limited to people with chronical lower back pain. From 2018 till 2020, 1,782 patients were asked for feedback The response was 38% The WHO was prescribed by a medical specialist (physician).
Introduction Symptoms of hand osteoarthritis (OA), such as pain, reduced grip strength, loss of range of motion (ROM) and joint stiffness, can lead to impaired hand function and difficulty with daily activities.1,2 OA is one of the most common chronic conditions that contributes to invalidity among the elderly (60+).3 The prevalence and incidence of OA are significantly higher for women than for men and increase with age. The majority of people older than 55 years of age have radiological features of hand OA, and 20% experience clinical symptoms.4,5 Most patients with hand OA report an increase in pain symptoms over a period of 2 years. However, hand OA does not always develop progressively. Grip strength deteriorates with disease progression.Patients' quality of lifewith hand OA depends on the frequency and duration of pain symptoms, and the duration of OA pain largely determines the patient’s level of (psychosocial) functioning.6,7 According to the European League Against Rheumatism (EULAR), the optimal management of hand OA includes both non-pharmacologic and pharmacologic approaches.8 Rehabilitative interventions with orthoses are commonly in the treatment of hand OA to reduce pain, improve hand strength and ROM, provide support for improved function and help with joint stability.9,10 is (SWHO) may serve as a suitable support for the affected hand joint and offer pain relief by limiting movement. Several systematic reviews have investigated and quantified the effectiveness of the conservative treatment of hand OA with orthoses. 2, 11-20 Although Towheed's12 systematic review reviewed studies of rehabilitative approaches, the main emphasis of these reviews was on methodological qualityratherthan treatment effects. The effectiveness of rehabilitation interventions, like SWHO, on specific treatment goals has not yet been fully explored.Previously published perception-based studies were based on relatively small population sizes, and therefore further research could add to our understanding of the effects of SWHO on patients with hand OA. To the best of our knowledge, there is a significant research gap in perception-based studies that seek to understand the short- and long-term effects of conservative treatments with orthoses and SWHO in particular on hand OA outcomes. Knowledge of the treatment effects of specific rehabilitation techniques for hand OA will be useful to help guide best clinical practice, and greater knowledge as to the effects of selected interventions on specific treatment goals will aid therapists in the selection of the most effective rehabilitation strategies for improving the impairment and function of individuals with hand OA. Evidence of treatment effects can be used in clinical practice to guide informed decision making and meet patient-specific goals. The objectives of this perception-based study were to evaluate the effect of a SWHO on pain and daily functioning. Secondly it was the aim to evaluate to what extent patients experience difficulties with or without SWHO on their daily live activities and evaluate the short- and longer-term effects of using a SWHO. Method Patient-reported outcomes (PROs) provide reports from patients about their own health, quality of life, and functional status associated with the health care or treatment that they have received.21 - 23 Between October 2018 and December 2020, 1,124 patients with hand OA were provided with a SWHO and asked about the effectiveness of the brace 3 weeks later. Within this group of 1124 patients, two groups were identified. The group of first time users and the group of patients who were fitted with a new SWHO (repeat users). Repeat users wore a SWHO at least three times a week over a period of 3 years. Use was validated with a Certified Prosthetist/Orthotist (CPO). All patients provided informed consent to participate in this study. Questionnaires were sent by e-mail, and responses were voluntary. All braces were supplied by Livit Orthopedie, a Dutch provider of orthopedic and prosthetic services and products. A physician (MD) confirmed the diagnosis of hand OA for all patients. Patients were asked about their activity limitations with and without a brace.24 The PROM questions in this study were based on the Patient Rated Wrist/Hand Evaluation (PRWHE).25 The PRWHE is a 15-item questionnaire designed to measure wrist pain and disability during activities of daily living.26,27 The following PROs were defined for this study based on the effectiveness of SWHOs: How has your daily function changed since you began using your SWHO? How have your pain symptoms changed since you began using your SWHO? Go to page 56. On an average day, to what extent do you experience difficulty with/without your SWHO when undertaking the following activities: writing, buttoning clothes, holding a book when reading, picking up phone, unscrewing jar/pot lids, household chores, lifting groceries, showering, bathing and dressing? These questions were asked to gain insights intodifferent types of hand function and with different typesof grip and finger use (Table 1). Questions related to daily activities were designed to address activities generally performed on a regular basis, were specific to various hand and wrist problems involving mobility and strength, and easy to understand for most patients. Questions covered three domains: personal care, household chores and work-related activities. Handdexterity was generally defined under two categories: power grips and precision grips, and questions covered both grips.28-31 The patients were asked to rate the impact of the SWHO on their degree of pain and ability to perform daily activities on a qualitative 7-point ordinal scale (ranging from very deteriorated to improved very significantly. The second part of the questionnaire consisted of questions about specific daily activities. Patients were asked to rate the amount of difficulty experienced with and without the use of a SWHO while performing the presented activities, rating their experienced difficulty on a qualitative 5-point ordinal scale (from “no problems” to “unable to perform”, see Fig. 4) Technical information SWHO are custom made orthopedic aids that relieve pressure and stabilize the enclosed body parts. This stabilization can reduce pain and prevent luxation in order to improve overall function and provides support in daily activities. These orthoses are individually manufactured. This ensures that the aid fits closely to the skin and is therefore comfortable to wear despite any hand deformities. Silicone is a material that is both flexible and rigid. Because of these properties, a SWHO provides gentle movement restriction while maintaining a slight freedom of movement. The products included in this study were fitted with Velcro fasteners and were passive, non-invasive medical devices classified as risk class I as defined by EU 93-42/EEC (figure 1 and figure 2). Statistics To assess the experienced improvement in functionality and pain, peer information is required. In this study, we compare the feedback from patients with and without a SWHO. The results are presented in bar charts and in frequency tables to enable a proper comparison between the outcome measures with and without SWHO. Descriptive statistics were used to describe the survey data and consisted of summary descriptions of frequency response distributions. The mode was used to measure central tendency.32With a population size of 6,500 patients who started using WHO in the Netherlands during the study period and a confidence level of 95%, a margin of error of 3% was calculated.33This expresses the amount of random sampling error in the survey results. Results The response rate of this PROM study was 49% (551 out of 1,124 patients). All responses have been analyzed and included as acceptable data in this study.Table 2 includes the descriptive characteristics of the study population. Short-term effects were assessed based on the responses of new users (67% of the population), and the long-term effects on the response of repeat users (33% of the population). In total, 63% of the respondents were age 60 or over, with 30% of the total respondents age 70 years or over.The majority of the respondents (81%) in this study were women. General Daily Functioning Figure 3 presents changes in the general daily functioning of patients who wore a SWHO. A total of 77% of respondents indicated that their daily functioning improved since they started wearing a SWHO, and 38% indicated that it had improved slightly and 36% stated that it had improved significantly. There was only a small difference between the patients who used a SWHO for the first time (improvement in 79% of respondents) and those who received a repeat provision (improvement in 74% of respondents). Only 7% of respondents stated that their functioning deteriorated after using the SWHO. Pain Reduction Figure 4 depicts changes in pain symptoms, which improved in 71% of patients. Only a small difference was noted between improvement in new users (improvement in 71% of respondents) and repeat users (improvement in 69% of respondents). Only 6% of those surveyed stated that their pain symptoms deteriorated after they started using the SWHO. Daily activities with and without shwo Figure 5 includes the results of questions asked regarding daily activities with and without SWHO. Results are presented for each daily activity in order of experienced difficulty. Patients experienced the most difficulty when performing household chores, activities that require a wide range of motor skills and hand grips.Only 4% of patients had ‘no difficulties’ with this activity without the use of a SWHO.The group experiencing ‘no or slight difficulties’ increased from 19% of the population without aid to 57% with the SWHO. The group experiencing limited difficulty more than doubled with SWHO use, while the group experiencing major difficulties declined by 67%. By assessing respondents’ ability to unscrew a jar, the effect of the SWHO on cylindrical grip was analyzed. The group experiencing ‘no or slight difficulties’ increased from 19% of the population without aid to 48% with a SWHO, representing an increase of 153%. The group experiencing ‘major problems’ reduced 55% with SWHO use, from 38% of the population to 17%. Insight into a hooked grip was gained with the question related to experienced difficulties lifting groceries. For this activity, the group experiencing ‘no or slight difficulties’ increased from 24% of the population without a device to 56% with a SWHO. The group unable to lift groceries changed from 12% to 9%. Patients reported a similar impact of the SWHO when holding a book: the group experiencing ‘no or slight difficulties’ increased from 38% without to 72% with the SWHO. The open hand grip when holding a book is clearly supported, as the ’no difficulties’ group increased from 16% to 37% while the group with severe difficulties reduced by 77% whilst wearing a SWHO (22% to 5%. With respect to buttoning clothing with and without a SWHO, the group experiencing ‘no or slight difficulties’ increased from 42% of the population without aid to 62% with a SWHO. The group unable to carry out this activity remained unchanged. To button clothing a pincer grip is needed, and a SWHO had a clear positive effect on the ability to do this. The group experiencing ‘no or slight difficulties’ with writing increased from 41% of the population without aid to 61% with SWHO. Holding a pen means that the patient is able to hold a small, thin object and operate it using fine motor skills. It appears that the patients experienced relatively fewer difficulties withshowering, bathing and dressing, as the patient group experiencing ‘minor or no difficulties’ was relatively high with and without the use of a SWHO (55% and 66% respectively). For phone use, the group experiencing ‘no difficulties’ increased from 34% to 48% of the population, an increase of 41%. The group experiencing ‘no or slight difficulties’ increased from 59% of the population without a device to 78% with a SWHO. The group experiencing major difficulties picking up the phone reduced from 10% to 4%. When wearing the aid, almost half of patients experienced no difficulties when operating or using a mobile telephone, a very important activity in modern life. When combined with the patient group experiencing minor problems, this percentage increased to 78%. Table 3 depicts patients with ‘minor or no difficulties’ with each activity with and without the silicone WHO. The greatest relative improvement was demonstrated in ‘household chores’ (+200%), ‘unscrewing jar/pot lids’ (+153%) and ‘lifting groceries’ (+133%). This study indicates that wearing a SWHO has a particularly significant impact on the performance of activities that require strength in their execution. These activities were in general experienced as more difficult, substantiated by the small number of patients who did not wear a SWHO experiencing ‘minor or no difficulties’. Table 4 shows the results when combining the patients with ‘major problems’ with those who were ‘unable to perform’ the activity for each activity with and without the use of a SWHO. There was a general improvement in all groups, and the range of outcomes was narrower compared with improvements in groups with ‘no or minor difficulties’ (Table 3). The biggest relative improvement was demonstrated in activities ‘holding a book’ and ‘domestic chores’. Discussion: In this PROM study, 77% of patients reported improved overall daily functioning when wearing a SWHO. Good progress was seen overall, but 23% of patients experienced no improvement or even deterioration in their function. Further research may help gain more insight into the reasons why patients do not experience improvement. Learning from their individual preferences improves the possibility that this work can potentially help improve the SWHO model. This study adds to the evidence reported by systematic reviews of conservative interventions for hand OA and further quantifies the effects of a tailor made SWHO.2,12-20 Common goals for the treatment of hand OA are pain relief, improved hand strength and ROM, and reduced stiffness, with an overall goal to improve physical hand function.10 Evidence-based practice requires knowledge of interventions that will most effectively address treatment goals and best target a prioritized problem.11,14 A hand OA orthosis is meant to reduce joint friction and prevent excessive joint stress by reducing joint movement. 8 Although critics of immobilization report that retaining normal tissue requires mobility, excessive mobilization of unstable arthritic joints may encourage further instability. Various studies have reported that an orthosis reduced pain and improved function during daily activities in patients with arthritis.19,34,35 Improvement in functioning during daily activities This study confirms that wearing a wrist orthosis has a particularly significant impact on the execution of static and repetitive wrist-straining activities. Examples of such activities are: lifting a bag of groceries and carrying items, household chores and holding a book. However, positive effects have also been observed in activities that require a lot of wrist movement or fine motor skills, such as: buttoning clothes, handling the phone, showering, bathing and getting dressed. Mechanically, an orthosis supports the hand or wrist in a favorable position, thereby avoiding unfavorable forces on the cartilage and caps/ligaments and allowing patients to experience less pain. Patients also experience more support with an orthosis, which is seen as an advantage when performing these activities. Wearing a SWHO may make an activity possible due to less pain and more support. In the past, advice was often given to wear a wrist orthosis throughout the entire day. In recent years, however, advice often involves wearing the wrist orthoses mainly during activities that put a strain onto the wrists.20 Given the results of this study, current advice can be further improved by including static activities that put a strain on the wrists so that those activities do not require wrist movement. Support for loss of strength Grip strength was shown to improve with SWHO use, as the group that experienced ‘no or mild problems’ increased significantly for activities requiring grip strength while wearing a SWHO, including; ‘lifting shopping bag’ (+133%), ‘unscrewing jar/pot lids’ (+153%) and ‘household chores’ (+200%). All three more than doubled. There is no consensus in the literature about the effects of wrist orthoses on hand strength.47,50 Although Steultjens et al. 42 concluded in their review that wrist orthoses may increase grip strength immediately after wrist orthosis provision, the results of prior work are not unequivocally in agreement with this. Egan 43 previously found insufficient evidence of hand strength improvement with a SWHO. Nordenskiold 44 and Kjeken 36 reported a direct significant increase in grip strength when using a wrist orthosis. The findings of the studies of Nordenskiold and Kjeken were based on smaller research populations of 60 patients or even less, while the present large scale study of 551 patients strengthens the suggestion of a positive effect of a SWHO on grip strength. Controlled studies are necessary to draw definite conclusions on the effects of SWHOs on grip strengths, and the positive findings of this study support the need for further research using a larger scale controlled study. Pain reduction This study shows that pain reduced by 71% with the use of a SWHO. Scientifically, most evidence was found for a short-term effect immediately after the wrist orthosis was provided. Several studies found that wearing a wrist orthosis led to a significant reduction in pain when carrying out activities.36-39 Van der Vegt 39 noted a minor reduction in pain scores in a group of 63 patients with hand OA when both tailor-made orthoses and a confection model were used. In the current study, a stronger improvement was shown following the use of a SWHO. Although this indicates that the use of a SWHO has a strong impact on daily activity performance whilst using a SWHO, further research is required with a comparative study between elastic orthoses and a SWHO to substantiate this hypothesis further. Repeat provisions are supplied 3 years after starting to wear a SWHO. This study noted long-term pain reduction in patients who used the SWHO for 3 years or longer. The positive effect on pain reduction for patients who received a repeat provision was 69%, of which 37% reported ‘significant improvement’ in pain reduction. These results were very similar to those of new users. The long-term effects of SWHOs are less uniform in literature. To date, only a few randomized controlled trials have been carried out where patients who wore a wrist orthosis for a certain time period were compared with control patients. Kjeken 40 found no significant difference between the intervention group and the control group in pain reduction after a period of 6 months ofr patients with hand OA, while Veehof 41 did find a significant difference between the two groups after 4 weeks. As such, this study contributes to the positive findings of Veehof for a longer-term effect of SWHOs and even demonstrates a pain reduction effect beyond 3 years, thereby contributing additional insight into the longer-term efficacy of SWHOs. Adverse effects of wrist orthoses This study shows that all activity groups improved with the use of the SWHO, with activities requiring more fine motor skills improving less than the activities that require gross motor skills. Patients cited both benefits and hindering effects when wearing wrist orthoses with respect to functional capabilities.41 Wrist orthoses are more often considered cumbersome during activities that require a lot of wrist movement, and may potentially reduce the speed of an action. The main adverse effect of a wrist orthosis in the literature is reduced dexterity.36 The use of an orthosis may worsen the grip and the speed of the action. De Boer 47 found that patients remove the orthosis because “it is in the way”. Differences in the tasks that are carried out could possibly explain these conflicting results. To manage expectations, it is important to inform patients that limitations due to their hand OA will not be eliminated altogether by a SWHO. The ultimate success of the wrist orthosis largely comes down to the individual patient; after all, the patient has to use the orthosis during daily work and routines and will experience both advantages and disadvantages. Limitations This work has several limitations. First, it was not recorded which model of SWHO the patient wore (Figs. 1, 2), or on which hand (dominant or not dominant). These aspects could have an influence on function with the SWHO. This study does not adjust for factors (sex, age, type of diagnosis) that can influence how people score on the PRWHE. However, doing so would add to the quality of the outcomes, and should be taken into account in future follow-up studies. Conclusions on the long-term effect of SWHOs are based on repeat supply to patients with a minimum use of 3 years. No insight is given into difference in SWHO efficacy at > 3 years. It would be of interest for future research to evaluate the possibility of benefit deterioration with a SWHO based on a longer time frame. Conclusion The results of this large-scale PROM study on the effectiveness of a SWHO in patients with hand OA shows that the use of a SWHO contributes to general daily function, reduces pain and increases the breadth of potential daily activities. Less pain makes it easier for patients to move and be active so that their lives can be more active once again and their quality of life can improve. Staying active actually helps enhance the patient’s self-reliance. Interventions to promote independent mobility should focus not only on preventing hand OA disability but also on restoring and maintaining independent mobility in older persons who become disabled.48This study shows that the use of a SWHO appears to offer pain relief and suitable support to the joint. Scientifically, little is known about ‘evidence-based’ wearing instructions and considerations when recommending wrist orthoses to patients with OA. With this study we hope to contribute practical advice on this topic for professionals to use in daily practice. References: Neogi, T. The Epidemiology and Impact of Pain in Osteoarthritis. Osteoarthr. Cartil. OARS Osteoarthr. Res. Soc. 21, 1145–1153 (2013). Ye L, Kalichman L, Spittle A, Dobson F, Bennell K. Effects of rehabilitative interventions on pain, function and physical impairments in people with hand osteoarthritis: a systematic review. Arthritis Res Ther. 2011 Feb 18;13(1):R28. PMID: 21332991; PMCID: PMC3241372. McAlindon, T. E. et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage 22, 363–388 (2014) Kalichman L, Hernández-Molina G. Hand osteoarthritis: an epidemiological perspective. Semin Arthritis Rheum 2010; 39: 465–476. Fumagalli M, Sarzi-Puttini P, Atzeni F. Hand osteoarthritis. Semin Arthritis Rheum 2005; 34: 47–52. Nunes MP, de Oliveira D, Aruin AS, Dos Santos JM. Relationship between hand function and grip force control in women with hand osteoarthritis. J Rehabil Res Dev. 2012;49(6):855–65. Peters-Veluthamaningal, Cyriac; Winters, Jan C.; Groenier, Klaas H.; Meyboom-de Jong, Randomised controlled trial of local corticosteroid injections for carpal tunnel syndrome in general practice, BMC Family Practice, Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Kaklamanis P, Kloppenburg M, Lohmander LS, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Smolen J, Verbruggen G, Watt I, Zimmermann-Gorska I, Escisit : EULAR evidence-based recommendations for the diagnosis of hand osteoarthritis: report of a task force of ESCISIT. Ann Rheum Dis. 2009, 68: 8-17. 10.1136/ard.2007.084772. Adams J, Hammond A, Burridge J, Cooper C. Static orthoses in the prevention of hand dysfunction in rheumatoid arthritis: a review of the literature. Musculoskeletal Care. 2005;3(2):85-101. PMID: 17041997. Kloppenburg M: Hand osteoarthritis--an increasing need for treatment and rehabilitation. Curr Opin Rheumatol. 2007, 19: 179-183. Sackett DL, Rosenberg WM: On the need for evidence-based medicine. J Public Health Med. 1995, 17: 330-334. Mahendira D, Towheed TE: Systematic review of non-surgical therapies for osteoarthritis of the hand: an update. Osteoarthritis and Cartilage. 2009, 17: 1263-1268. 10.1016/j.joca.2009.04.006. Mejjad O, Maheu E: Therapeutic trials in hand osteoarthritis: A critical review. Osteoarthritis and Cartilage. 2000, 8: S57-S63. 10.1016/S1063-4584(99)80017-X. Moe RH, Kjeken I, Uhlig T, Hagen KB: There Is Inadequate Evidence to Determine the Effectiveness of Nonpharmacological and Nonsurgical Interventions for Hand Osteoarthritis: An Overview of High-Quality Systematic Reviews. Physical Therapy. 2009 Mahendira D, Towheed TE. Systematic review of non-surgical therapies for osteoarthritis of the hand: an update. Osteoarthritis Cartilage. 2009 Oct;17(10):1263-8. Epub 2009 Apr 17. PMID: 19410030. Bertozzi L, Valdes K, Vanti C, Negrini S, Pillastrini P, Villafañe JH. Investigation of the effect of conservative interventions in thumb carpometacarpal osteoarthritis: systematic review and meta-analysis. Disabil Rehabil. 2015;37(22):2025-43. Epub 2015 Jan 5. PMID: 25559974. Lue S, Koppikar S, Shaikh K, Mahendira D, Towheed TE. Systematic review of non-surgical therapies for osteoarthritis of the hand: an update. Osteoarthritis Cartilage. 2017 Sep;25(9):1379-1389. Epub 2017 Jun 15. PMID: 28602781. Roll SC, Hardison ME. Effectiveness of Occupational Therapy Interventions for Adults With Musculoskeletal Conditions of the Forearm, Wrist, and Hand: A Systematic Review. Am J Occup Ther. 2017 Jan/Feb; PMID: 28027038; PMCID: PMC5182014. Valdes K, Marik T. A systematic review of conservative interventions for osteoarthritis of the hand. J Hand Ther. 2010 Oct-Dec;23(4):334-50; quiz 351. Epub 2010 Jul 8. PMID: 20615662. Van der Horst M, Oude Ophuis T, Boer K, Veehof M, Consensus polsorthesen bij artritis Sectie ergotherapie van de Nederlandse Health Professionals in de Reumatologie, (NHPR), maart 2010 Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013;6:61-68. Published 2013 Aug 4. PROM-toolbox, ttps://www.zorginzicht.nl/kennisbank/ paginas/prom-toolbox.aspx NIVEL, IQ healthcare, VSOP (Vereniging Samenwerkende Ouder- en Patiëntenorganisaties) en Patiëntenfederatie Nederland, in opdracht van Zorginstituut Nederland, PROM-wijzer, 27 juni 2018 Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. PMID: 8263569. MacDermid JC, Tottenham V. Responsiveness of the disability of the arm, shoulder, and hand (DASH) and patient-rated wrist/hand evaluation (PRWHE) in evaluating change after hand therapy. J Hand Ther. 2004 Jan-Mar;17(1):18-23. PMID: 14770134. Angst F, John M, Goldhahn J, Herren DB, Pap G, Aeschlimann A, Schwyzer HK, Simmen BR. Comprehensive assessment of clinical outcome and quality of life after resection interposition arthroplasty of the thumb saddle joint. Arthritis Rheum. 2005 Apr 15;53(2):205-13. PMID: 15818645. MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998 Nov-Dec;12(8):577-86. PMID: 9840793. Long C 2nd, Conrad PW, Hall EA, Furler SL. Intrinsic-extrinsic muscle control of the hand in power grip and precision handling. An electromyographic study. J Bone Joint Surg Am. 1970 Jul;52(5):853-67. PMID: 5479476. Marzke MW. Precision grips, hand morphology, and tools. Am J Phys Anthropol. 1997 Jan;102(1):91-110. PMID: 9034041. Landsmeer JM. Power grip and precision handling. Ann Rheum Dis. 1962 Jun;21(2):164-70. doi: 10.1136/ard.21.2.164. PMID: 14461996; PMCID: PMC1007266. Eyler DL, Markee JE. The anatomy and function of the intrinsic musculature of the fingers. J Bone Joint Surg Am. 1954 Jan;36-A(1):1-9; passim. PMID: 13130582. O’Brien, Bridget C. PhD; Harris, Ilene B. PhD; Beckman, Thomas J. MD; Reed, Darcy A. MD, MPH; Cook, David A. MD, MHPE Standards for Reporting Qualitative Research, Academic Medicine: September 2014 - Volume 89 - Issue 9 - p 1245-1251 RIVM, 2021 20 Decemeber, https://www.volksgezondheidenzorg.info/ onderwerp/artrose/cijfers-context/trends Behrens F, Kraft EL, Oegema TR Jr.Biochemical changes in articular cartilage after joint immobilization by casting or external fixation. J Orthop Res. 1989;7(3):335-43. doi: 10.1002/jor.1100070305. Erratum in: J Orthop Res 1990 Jul;8(4):627. PMID: 2703926. Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Macé Y, Beaudreuil J, Richette P, Ravaud P, Revel M, Poiraudeau S. Splint for base-of-thumb osteoarthritis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):661-9. PMID: 19451573. Kjeken I, Smedslund G, Moe RH, Slatkowsky-Christensen B, Uhlig T, Hagen KB. Systematic review of design and effects of splints and exercise programs in hand osteoarthritis. Arthritis Care Res. 2011;63(6):834–48. Ye L, Kalichman L, Spittle A, Dobson F, Bennell K. Effects of rehabilitative interventions on pain, function and physical impairments in people with hand osteoarthritis: a systematic review. Arthritis Res Ther. 2011;13(1):R28. Grüschke JS, Reinders-Messelink HA, van der Vegt AE, van der Sluis CK.User perspectives on orthoses for thumb carpometacarpal osteoarthritis. J Hand Ther. 2019 Oct-Dec;32(4):435-443. Epub 2018 Jul 17. PMID: 30025837. Vegt AE, Grond R, Grüschke JS, Boomsma MF, Emmelot CH, Dijkstra PU, Sluis CK.The effect of two different orthoses on pain, hand function, patient satisfaction and preference in patients with thumb carpometacarpal osteoarthritis: a multicentre, crossover, randomised controlled trial. Bone Joint J. 2017 Feb;99-B(2):237-244. Erratum in: Bone Joint J. 2017 May;99-B(5):702-704. PMID: 28148667. Kjeken I, Moller G., Kvien TK. Use of Commercially Produced Elastic Wrist Orthoses in Chronic Arthritis: A Controlled Study. Arthritis Care Res 1995;8(2):108-13. Veehof MM, Taal E, Heijnsdijk-Rouwenhorst LM, van de Laar.Efficacy of wrist working splints in patients with rheumatoid arthritis: a randomized controlled study. Arthritis Care & Research 2008;59(12):1698-1704. Steultjens EM, Dekker J, Bouter LM, van Schaardenburg D, van Kuyk MA, van den Ende CH.Occupational therapy for rheumatoid arthritis.Cochrane Database Syst Rev. 2004;(1):CD003114. Egan M, Brosseau L, Farmer M, Ouimet MA, Rees S, Wells G, Tugwell P. Splints/orthoses in the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. 2003;(1):CD004018 44.Nordenskiöld U. Elastic wrist orthoses: reduction of pain and increase in grip force for women with rheumatoid arthritis. Arthritis Care Res 1990;3:158-62. 45.Stern EB, Ytterberg SR, Krug HE, Mahowald ML. Finger dexterity and hand function: effect of three commercial wrist extensor orthoses on patients with rheumatoid arthritis. Arthritis Care Res 1996;9:197-205. 46.Stern EB, Ytterberg SR, Krug HE, Mahowald ML. Finger dexterity and hand function: effect of three commercial wrist extensor orthoses on patients with rheumatoid arthritis. Arthritis Care Res 1996;9:197-205. 47.De Boer IG, Peeters AJ, Ronday HK, Mertens BJ, Breedveld FC, Vlieland TP.: The usage of functional wrist orthoses in patients with rheumatoid arthritis Disabil & Rehabil. 2007 May 9;:1-10 [Epub ahead of print] 48.Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. PMID: 24866862; PMCID: PMC4266388 49.Magni NE, McNair PJ, Rice DA. The effects of resistance training on muscle strength, joint pain, and hand function in individuals with hand osteoarthritis: a systematic review and meta-analysis. Arthritis Res Ther. 2017 Jun 13;19(1):131. PMID: 28610637; PMCID: PMC5470180. 50.Bobos P, Nazari G, Szekeres M, Lalone EA, Ferreira L, MacDermid JC. The effectiveness of joint-protection programs on pain, hand function, and grip strength levels in patients with hand arthritis: A systematic review and meta-analysis. J Hand Ther. 2019 Apr-Jun;32(2):194-211. Epub 2018 Dec 23. PMID: 30587434. Authors: Wouter Akkerman, CPO, Director Livit Orthopedie, Amsterdam, Netherlands, wakkerman@livit.nl MarloesHofstra, MSc in Occupational Therapy, Xpert Handtherapie, Rotterdam, M.Hofstra@xperthandtherapie.nl Jan Willem Van der Windt, MSc, CEO Livit Orthopedie, Amsterdam, Netherlands, jwindt@livit.nl Peter Meussen, CPO Livit Orthopedie, Amsterdam, Netherlands, pmeussen@livit.nl
Table 1: Daily activities and different types of hand function
6 - SILICONE WRIST HAND ORTHOSIS
Daily Activity
Grip Type
Grip description
Personal Care
Showering, bathing and getting dressed
Precision grip
Fine motoric skills
Buttoning Clothes
Pincer grip; two-point tip pinch or tip tp tip grip of the fingers
Household chores
Domestic chores
Power grip
Amongst others the Spherical grip; grip in which the hand curves to hold a round or sphere-shaped object
Lifting groceries
Hook grip; involves flexion digits 2-5 to hold the object in a hook-like manner (20)
Opening jars
Cylindrical grip; requires use and strength of the extrinsic muscles and intrinsic muscles of the hand in order to flex the fingers around curved objects
Work
Writing
Pincer grip; three-point tip pinch where the thumb meets with the tips of digits 2 and 3
Holding a book while reading
Open hand grip; the defining characteristic is having all the joints bend naturally inward.
Handling the phone
Use of the thumb with fine motoric skills
SILICONE WRIST ORTHOSES
Example: thumb orthoses cmc1 Stabilising and supporting around CMC1 joint (and MCP1 if required)
Freedom of movement
Model CMC1 - long: The brace has a stabilizing and supporting function around the CMC1 and MCP1 joint. It also has a limited stabilizing function around the wrist. This will ensure that the movements of CMC1 and MCP1 are fully restricted and the dorsal and palmar flexion in the wrist is partially restricted, reducing pain. The motion in CMC1and MCP1 is fully restricted, and the dorsal and palmar flexion in the wrist is partially restricted. Slight freedom of movement remains possible due to the flexible nature of the material.
Model without thumb: The brace has a stabilizing and supporting function around the wrist. This will ensure that dorsal and palmar flexion is limited and pain reduced. Freedom of movement remains possible thanks to the suppleness of the material.
Example: orthoses stabilizing and supporting the wrist (and CMC1 joint if required)
Local reinforcement
Model CMC1 - short: The brace has a stabilizing and supporting function around the CMC1 joint. This ensures restriction of movement and pain reduction. Movements in the CMC1 and MCP1 are restricted. The flexibility of the material allows for slight freedom of movement.
Figure 1: Example of silicone wrist hand orthoses (Source: Livit SWHO catalogue).
The silicone wrist orthosis (SWHO) is an individualized static or dynamic forearm device that serves to relieve pressure and stabilize the enclosed body parts. The stabilization can reduce pain and prevent luxation. This improves overall function and provides support in the performance of GDA. These devices are individually manufactured. This ensures that the device fits closely to the skin and is therefore very comfortable to wear. Silicone is a flexible material which, when reinforced, can provide the right amount of support for the arm. Explanation new properties Silicone is a material that is both flexible and rigid. Because of these properties, a silicone SWHO can achieve a gentle restriction of movement, while maintaining a slight freedom of movement. This provides increased comfort. Normally silicone is made of two layers of 2mm thick silicone. The slimline option consists of one layer of 2mm silicone and is therefore more flexible. The Pré-skin version consists of an outer shell in a colour of your choice and an antibacterial white inner shell. This brace is suitable for people who have fragile or easily irritated skin.
Model with thumb: The brace has a stabilizing and supporting function around the wrist and cmc1. This will ensure that the dorsal and palmar flexion of the wrist and all the movements of cmc1 and mcp1 are restricted and reduce pain. Slight freedom of movement remains possible due to the suppleness of the material.
Easy to put on and take off
Figure 2: Example of silicone wrist hand orthoses (Source: Livit SWHO catalogue).
Thin spout
Table 2: Descriptive characteristics of the study population
551
444
107
81%
44%
OA
100%
Figure 4: Change in pain symptoms expressed in percent of total
Figure 5: Experienced problems during daily activities with and without a silicone wrist hand orthosis
Table 3: Daily activities for best two groups combined (no problems and minor problems)
Figure 3: Change of general daily functioning expressed in percent of total
Activity level without SWHO
no problems
minor problems
(a) Total
56%
133%
Holding a book when reading
38%
72%
89%
Buttoning clothes
42%
41%
62%
48%
61%
49%
Showering, bathing, getting dressed
55%
66%
Picking up the phone
59%
78%
Activity level with SWHO
Change in % (b/a-1)
(b) Total
57%
200%
153%
major problems
unable to perform
-74%
-26%
-32%
-27%
Change in %
-44%
Table 4: Daily activities for groups with major problems and unable to perform combined
Introduction The ORTEAM® Ankle Foot Orthosis (AFO) is an individualised dynamic lower leg device, which is characterised by slots on the dorsal side at the level of the malleoli with the function in the swing phase and part of the stance phase to correct the ankle position and allow free movement to dorsiflexion where possible. An ORTEAM® AFO can be used in patients with reduced strength of the foot lifters. By supporting and compensating for this muscle action in the lower leg and foot, the ORTEAM® AFO improves the user's overall mobility.With the ORTEAM® AFO, 50% more improvement in walking possibilities has been observed compared to a conventional plastic AFO. Thanks to its unique construction, this ORTEAM® AFO supports the loss of muscle strength in the lower leg and foot in a very unique way. The ORTEAM® AFO is a patented AFO that allows greater freedom of dorsiflexion than standard AFOs without the need for large and heavy hinges. The movement towards plantar flexion is thereby inhibited. Inhibiting plantar flexion also provides adequate foot clearance in the swing phase. Summary The results of this large-scale PROM study among 142 patients into the effectiveness of synthetic ankle-foot orthoses show that the use of an AFO serves as an adequate facility for improving freedom of movement and ADL activities. 80% of patients experience an improvement in functioning when using an AFO. All patients have a paresis of the foot lifters. This study also shows that, due to its unique construction, the ORTEAM® AFO provides 50% extra ADL mobility compared to the conventional plastic AFO. The use of an ORTEAM® AFO is therefore proven to contribute to general daily functioning and increases the user's walking possibilities. What is unique about the ORTEAM® AFO? Limited plantar flexion possible during the first rocker (at initial contact); Due to its unique construction, the AFO allows dorsiflexion during the 2nd and 3rd rocker Strong yet lightweight material Can be individualised cosmetically by means of a print and made to fit in (off-the-shelf) shoes. Problems with conventional ankle-foot orthoses The ORTEAM® AFO can be worn by people with paresis of the dorsal flexors (foot lifters). Due to the weakness of the dorsal flexors, a reduced foot lift occurs during the swing phase. This could cause the patient to trip and fall. In addition, walking with a reduced foot lift costs more energy than walking with a normal gait. When there is a spastic paresis, plantar flexion of the foot causes a clonus in which the lower leg starts to cramp and moves involuntarily. An AFO ensures sufficient foot lift/dorsiflexion in the swing phase, preparing the foot for initial contact and stability in the stance phase. If the patient suffers from a spastic paresis, the clonus of the foot appears to decrease sharply as soon as the foot is at a 90° angle to the lower leg (the 'zero' position). A conventional AFO is made of thin-walled material, which means that the AFO can in principle be worn in combination with normal shoes. Due to the construction and material properties of a conventional AFO, it is fairly stiff in plantar flexion and dorsiflexion, which can lead to a reduced range of motion of the ankle. In most cases, a more dynamic AFO is desired so that the patient develops a gait closer to normal gait. Rolling over while walking is in particular understood to mean that the angle between the foot and the lower leg is reduced when the body's centre of gravity on the foot is shifted from the heel to the toes during walking. When walking, the ankle joint will always assume the same position there.When using a conventional AFO, this movement in the ankle will be limited by the stiffness of the material. This creates a less dynamic gait pattern, which is undesirable in most cases. The consequence of this static gait is that there is an annoying sliding movement between the heel and the AFO. To allow the desired dorsiflexion in the ankle, the upright sidewalls of the AFO, which are located both medial and lateral to the malleoli, will move outward. When this happens frequently, the thin-walled material at the malleoli cracks due to fatigue. The ORTEAM® AFO improves walking comfort and thus mobility The ORTEAM AFO offers a solution to the above problems. The solution is characterised by providing multiple slots in the horizontal direction at the ankle joint. These are separated from each other and are located on the dorsal side of the AFO. The slots act as a special hinge. (see figure below) The ORTEAM® has the property that it is stiff (sprung) on initial contact. However, when a sufficiently large force is exerted on the body during walking, the above-mentioned angle between the sole of the foot and the shaft of the AFO can decrease. This reduction of the angle occurs during rolling over. The connection between the sole of the foot and the upright rear wall is more dynamic here than the conventional AFO and allows this angle to be reduced. In addition, this angle extends itself back to its original position when the load is released from the leg, such as in the swing phase of the leg. When said angle between the sole of the foot and the upright rear wall is reduced, the slots open further. However, the side walls do not bend outwards at the level of the ankles such that wear occurs in the thin-walled body. The ORTEAM® AFO thus allows dynamics while walking without wear and tear and without extra energy consumption of the user. The slots ensure that the AFO stiffens towards plantar flexion upon initial contact. In this part of the movement, the slots are pinched shut, as it were. When the slots are pinched, it is not possible to further increase the included angle and hyperextension of the knee is prevented. The ORTEAM® therefore has the property that it can be bent in a sprung fashion, in which context this included angle can be reduced by a relatively large angle. This allows a dorsiflexion and the patient therefore has improved roll over and walking on, or standing up from a chair. This ensures better energy management and improved walking distance. In addition, this angle can only increase to a limited extent in the opposite direction. This allows only a very limited plantar flexion, which provides a foot lifting effect as the upper part of the AFO moves upwards relative to the sole of the foot. Some AFOs are made with rods and hinges, the hinge of which is connected to the sole of the foot. However, these AFOs have metal rods, with the disadvantage that they can hardly be worn inconspicuously due to their large size.In addition, these AFOs are a lot heavier and the hinges often make noise, which is experienced as unpleasant. Research into effectiveness Evidence-Based Medicine (EBM, ed.) is a way of working in which a treatment method is chosen that has the best effect from a scientific point of view. However, in context-dependent healthcare, clinical experience and patient wishes and values also play a major role in providing good care in the doctor's office (Raad van Volksgezondheid en Sport ('Council for Public Health and Sport'), 2017, ed.). The increase in the amount of outcome information coming from Patient Reported Outcome Measures (PROMs) and Patient Reported Experiences (PREMs) enables us to reliably measure the effect of our treatments on the perceived health and daily functioning of our patients. Livit has conducted a study into the effectiveness of the ORTEAM® AFO, comparing experiences with and without the aid. The study group consisted of patients who received the ORTEAM® AFO and a group who were fitted with a conventional plastic AFO. The PROM questions in the study were drawn up on the basis of the usual questionnaires known in orthopaedics/ orthopaedic surgery, which are in line with scientifically accepted and validated PROM questions. The medical indication paresis of the foot lifters has been determined by a medical specialist. All patients participated voluntarily in the study. Participants In 2021, 142 patients with dorsal flexor paresis participated in the study. They were asked about the effectiveness of the AFO three weeks after using the new AFO. The questionnaires were sent by email. The patients were approached once by email and it was a voluntary questionnaire. The questionnaire consisted of 12 questions, each with a qualitative ordinal scale in terms of functioning and activity. Patients were asked about limitations with and without AFO. The results of the study The questions are described below with the differences in outcome between the conventional plastic AFO and the ORTEAM® AFO. How is your general day-to-day functioning without using your ankle-foot orthosis? The group of patients who experience the functioning without AFO as poor or very poor represents 55% of the group with an ORTEAM® AFO and 60% of the group with a conventional AFO Both patient groups therefore indicate a comparable level of difficulty in daily functioning without the use of an AFO. How has your general day-to-day functioning changed since using your ankle-foot orthosis? Wearing an AFO contributes to an experienced improvement in daily functioning. Of the group of patients who started wearing ORTEAM, 86% experienced an improvement and of the group who started using a conventional AFO, 79% experienced an improvement. What are your walking possibilities if you do/do not wear your AFO? The group with an ORTEAM® indicates a strong increase in walking possibilities. The group that can walk more than 200 metres is 2.5 times as large! (from 25% to 58%) The group with a conventional AFO indicates a lower increase in walking possibilities. The group that can walk more than 200 meters is 1.5 times as large (from 31% to 47%) The mobility factor is a weighted average of the various mobility classes. For the group of patients with an ORTEAM®, the mobility factor increases from 3.6 to 5.7, which is an increase of 59%. For the group of patients with a conventional plastic AFO, the mobility factor increases from 3.9 to 5.4. The patients with the ORTEAM® experienced 50% more improvement in walking possibilities than patients who used a conventional plastic AFO (difference growth % mobility factor). Conclusion: This study shows that patients with a conventional AFO experience a 40% increase in their walking possibilities. For the ORTEAM® this was even 50%. Finally By sharing patient-reported outcome measurements, Livit hopes to contribute to improving the care for our customers and to a quality improvement in orthopedic device care in general. More information about this research can be found in a professional presentation on www.zorgprofessionals.livit.nl or you can contact Wouter Akkerman, (Director of Operational Management) at wakkerman@livit.nl. Sources: Programmatekst Goed Gebruik Hulpmiddelenzorg 2018 - 2020 ('Program text Good Use of Medical Devices 2018 — 2020'), ZONMW, June 2017 Verkenning extramurale hulpmiddelen met aanspraak op basis van de zorgverzekeringswet en hulpmiddelen voor diabetes ('Exploration of extramural devices with entitlement on the basis of the health insurance law and devices for diabetes'), ZonMw, 21 August 2015 Patiënten participatie bij PROMS ('Patient participation in PROMS') | April 2015:Nederlandse Patiënten Consumenten Federatie ('Dutch Patients Consumer Federation') WO1998007395 - ANKLE-FOOT-ORTHOSIS,https:// register.epo.org/application?number= EP97935898&tab=main Authors: Frank Bosch (CPO), Sabine Kuhne (CPO), Gerrit van Zuijlen (CPO), Pieter van der Snoek (CPO), Wouter Akkerman (Director Operational Management) en Jan Willem Van der Windt (CEO)
orteam® afo Users of the ORTEAM AFO experience 50% more improvement in walking possibilities than users of a conventional plastic AFO!
ORTEAM.® THERMOPLASTIC ANKLE-FOOT ORTHOSIS
The results of this large-scale PROM study among 142 patients into the effectiveness of synthetic ankle-foot orthoses show that the use of an AFO serves as an adequate facility for improving freedom of movement and ADL activities. 80% of patients experience an improvement in functioning when using an AFO. All patients have a paresis of the foot lifters.
By sharing outcome measurements WE contribute to improving the care for our customers and to a quality improvement.
7 - ORTEAM® AFO
Medical conditions
Stiff at heel contact.
Laterale Führung
PHO type
Werkingsprincipe
Type 1
Paresis: peripheral paralysis (total or partial)
Type 2
CVA - MS - Paresis or paralysis of the foot drop braces with a slight to moderate moderate varus or valgus tilt if correctable
Type 3
Spastic paresis with uncontrollable clonus in which dorsiflexion is possible, with or without varus or valgus tilt
Type 3a
CVA - MS with; - paresis or paralysis of the foot drop braces. - severe hyperextension of the knee
Type 3b
CVA - MS- with; - paresis or paralysis of the foot drop braces. - slight hyperextension in the knee
Type 3c
CVA - Polio - MS - Guillam Barre with; - paresis or paralysis of the foot drop braces. - mild quadriceps insufficiency.
Type 3d
Spastic Paresis. Correction after lumpy foot surgery. Foot surgery. Deployment mainly with children.
Type 4
Spastic paresis. Correction after l<lumpy foot surgery. Foot surgery. Deployment mainly with children.
Type "Tatum"
Cervical palsy with a Becher gait type II or mild Ill
Colors and designs
Fits in confection shoes
Hinge by means of slots
The ORTEAM® Ankle-Foot Orthosis (AFO) is an individualized dynamic lower leg support with slits in the malleoli to provide dynamic support for the entire stance phase. By supporting and correcting the muscle function at the ankle and foot, the ORTEAM® AFO improves the user's overall mobility. An ORTEAM AFO can be used in patients with reduced strength of the foot lifters. Thanks to a unique construction, this orthosis supports the articulation, sliding and rotational movements of the ankle in a way that no other orthosis can. The ORTEAM® AFO is a patented AFO that allows more freedom of thrust than standard AFOs without the need for hinges. There is still plantar inhibition, which prevents the knee from going into hyperextension. The ORTEAM® AFO is delivered fully finished within two weeks. What is unique about ORTEAM AFO? Limited plantar flexion possible during the first rocker (at initial contact); Due to its unique construction, the AFO allows dorsiflexion during the 2nd and 3rd rocker Strong yet lightweight material Can be individualised cosmetically by means of a print and made to fit in (confection) shoes.
Orteam
Thermo Plastic AFO
30 - 60
22
60 -70
28
15
70 - 80
19
> 80
11
84
58
Table 1: demografics of this study
Table 2: change in general day-to-day functioning
How is your general day-to-day functioning without using your ankle-foot orthosis?
Very bad
Bad
Poor
Orteam AFO
Plastic AFO
How has your general day-to-day functioning changed since using your ankle-foot orthosis?
Much deteriorated
A little deteriorated
Unchanged
A little improved
Much improved
Very much improved
Improved
46%
86%
79%
Reasonable
Good
Figure 1: Change in mobility expressed in percent of total
Figure 2: change in mobility by mobility class
ORTEAM.® TYPE 1 - Paresis: peripheral paralysis.
Text
ORTEAM.® TYPE 2 - CVA, MS, Paresis: peripheral paralysis.
illustration:
Indication: Paresis: peripheral paralysis (total or partial). Function: Support of the foot drop braces during the swing phase. Dorsal flexion possible. Springy resistance against plantar flexion. Applications: Dorsiflexion is smooth. Plantar flexion encounters resistance. The foot is held firmly at 90°. The heel area is stable in the shoe. AFO can be worn in different shoes (with the same heel lift). In the stance phase, no irritating pressure on the calf. Foot part only with low trim lines, no option for high medial or lateral. Measurement method: According to cast negative for CAD/CAM method. According to digital STL-file from scan for CadCam method. Model: Standard model. The length is over the middle of the calf. There are 5 large slots and 4 small slots. Material: Thermoplastic AFO made of PolyPropylene. Options: Soft polyform padding in the calf area. Comfortable shin strap velcro wrap-around closure with soft padding inside. Leather shoe/sandal with Velcro or lace fastening (leather smooth side against skin).
Indication: CVA - MS - Paresis or paralysis of the foot drop braces with a slight to moderate varus or valgus tilt if correctable. Function: Support of the foot drop braces during the swing phase. Dorsal flexion possible. Spring resistance to plantar flexion. Support of varus or valgus tilt. Applications: Dorsiflexion is smooth. Plantar flexion encounters resistance. The foot is held firmly at 90°. The heel area is stable in the shoe. AFO can be worn in different shoes (with the same heel lift). In the stance phase, no annoying pressure on the calf and varus or valgus support. Even without small grooves. Measurement method: According to cast negative for CAD/CAM method. According to digital STL-file from scan for CadCam method. Model: Normal model. The length is over the middle of the calf. There are 5 large slots and 4 small slots. Additional lateral support on the varus or valgus side. Material: Thermoplastic AFO made of PolyPropylene. Options: See Type 1 Extra closure strap placed above the ankle. Leather shoe/sandal with a Velcro or lace fastening (leather smooth side against skin).
Indication: Spastic paresis. Correction after clubfoot surgery. Foot correction. Function: Maintain foot in a corrected position allowing dorsiflexion. Applications: Dorsiflexion is springy. Plantar flexion is not possible. Measurement method: According to cast negative for CAD/CAM method. According to digital STL-file from scan for CadCam method. Model: Solid design. The length is up to the middle of the calf. There are 5 large slots. No small slots. Material: Cowhide inner boot (leather smooth side on the skin) with on top the synthetic material, model as type 3 of PolyPropylene covered with lining leather (Ross nappa (horse)). Foot part has lacing, the lower leg has 3 to 4 Velcro straps.
Indication: Spastic paresis with uncontrollable clonus in which dorsiflexion is possible, with or without varus or valgus tilt. Function: Support of the foot drop braces during the swing phase. Dorsal flexion possible. Spring resistance to plantar flexion. Support of varus or valgus tilt. Applications: The foot cannot go into plantar flexion. The spasm can be held back well. The heel plane is stable in the shoe. The AFO can be worn in different shoes (with the same heel lift). In the stance phase (90°) there is no irritating pressure on the calf. Measurement method: According to cast negative for CAD/CAM method. According to digital STL-file from scan for CadCam method. Model: Solid design. The length should be maximum, this is 3 cm below the bottom edge of the fibula head. The depth is measured from the back to 7 mm beyond the centre of the side. There are 5 large slots and 6 small slots. Material: Thermoplastic AFO made of PolyPropylene. Options: Soft polyform padding in the calf area. Comfortable shin strap velcro closure with soft padding inside. Same velcro strap placed over the instep including slider. Extra closure strap placed above the ankle.
ORTEAM.® TYPE 3 - Spastic paresis
ORTEAM.® TYPE 3A - Spastic paresis after foot surgery
ORTEAM.® TYPE 3B - Spastic paresis
ORTEAM.® TYPE 4 - Spastic paresis after foot surgery
The Orteam® AFO Tatum is a custom-made synthetic ankle-foot orthosis designed for children with gait type 2 or mild gait type 3 AGC (Amsterdam Gait Classification). It is one of our patented products developed by orthopaedic consultants. A walking type 2 or mild type 3 AGC continues often in children with cerebral palsy (CP). In this disorder, there has been a shortage of oxygen in the brain before, during or after birth (for example, due to a brain infarct). The area of the brain responsible for the correct muscle balance is disturbed, causing posture and movement problems. In relation to this, for example, the foot is often not lifted effectively during walking. Thanks to a unique construction, this orthosis supports the articulation, sliding and rotational movements of the ankle in a way that no other orthosis can. The ORTEAM® AFO is a patented AFO that allows more freedom of thrust than standard AFOs without the need for hinges. There is still plantar inhibition, which prevents the knee from going into hyperextension. What is unique? Limited plantar flexion possible during the first rocker (at initial contact); Due to its unique construction, the AFO allows dorsiflexion during the 2nd and 3rd rocker Strong yet lightweight material Can be individualised cosmetically by means of a print and made to fit in (confection) shoes.
Specifically designed for children
ORTEAM.® type tatum, AFO for children
This research shows that therapy adherence is high and improvement is experienced by wearing TEK.
Between '17 and '20, 77,550# patients with TES were asked to complete a questionnaire. In all cases, the TES were prescribed by a medical doctor. The response rate of this outcome study was 44%;
The importance of Therapeutic Elastic Stockings (TES) is often underestimated due to insufficient knowledge. Also, therapy adherence (compliance) of compression therapy is often questioned. TES are used when the veins or lymphatic vessels can no longer transport the blood or lymph properly. The TES must compensate for the loss of function for a long time. The purpose of this article is to map the patient-reported outcome of compression therapy. This is a study on the effect and adherence of compression therapy based on patient-reported outcome measurements (PROM). More than two-thirds of the respondents experience an improvement in complaints by wearing TEK and experience more ease of use due to a better fit. For some third of the customers, the complaints are stabilized.
Introduction 380,000 patients are prescribed therapeutic elastic stockings (TES) every year.1 This number is expected to rise sharply over the coming years due to the increasingly ageing population and related diseases of old age.2 Patients and patient organisations are increasingly engaged in improvements to the quality of care. In many cases, patients wish to play a larger part in their own care pathway, and make decisions jointly with their care providers. In addition, patients are ever more considered to be partners with respect to the care plan, and care professionals apply the customer experience as a starting point in their advice and actions. The Compression Device Care Module assumes that the process of prescribing is centered on the client’s functioning.3 In doing so, compression device care must be client-centered, effective, efficient, and transparent. As well as collaborative decision-making and function-based prescribing, encouraging clients’ self-management and stepped care are important principles in moving through the process.4,5 There is no consensus in the literature on the effect and compliance of compression therapy.6,7,8 In order to arrive at reliable information on the quality and the outcomes of the care provided, it must be measured first. One method is to ask customers about the effect of the care/treatment by way of a patient-reported outcome measurement (PROM). The aim of this article is to discuss the patient-reported outcome of compression therapy. Every party benefits from transparency in care: the patient, who receives better care, the care provider, who offers more efficient and effective care, and the healthcare insurer, who can validate the effectiveness of the care it procures. Method Livit initiated a study of TES in 2017. This focuses on the customers' experiences after using the TES. Customers shared their experiences on four topics: therapy compliance, symptom reduction, fit, and ease of use of the stocking. PROM research9 is a method for measuring health outcomes and quality of life, and for offering insight into the (added) value of care for patients, which in turn may contribute to improvements to the quality of this care. PROM questionnaires measure the perceived health, quality of life, and functioning from the patient’s perspective. Together with the Patient Reported Outcomes (PRO) network, the Dutch National Health Care Institute (Zorginstituut Nederland) has developed and made available an online toolbox10 which served as a guide for the outline of this research. The PROM toolbox describes the entire PROM selection and application process in eight steps. Each steps refers to relevant tools and offers practical advice using everyday examples. The aspects of health can be measured at different levels. The following PROs were defined for this study on the effectiveness of TES: Do you wear the stockings? Have you experienced an improvement since wearing the stockings? Which symptoms have not reduced sufficiently? How satisfied are you with thewearing comfort, fit, and ease of use?’ Statistics Standards, outcome indicators, reference values, and context information are essential to interpret the PROM information.11 There are no standard values or target values that could be used in the study; it is not known whether there are comparable studies on the effectiveness of TES. The primary outcome measure was the perceived improvement and therapy compliance to the compression therapy, assessed using an ordinal rating scale. Secondary outcome measures were: fit, wearing comfort, and ease of use.12 Between January 2017 and December 2020, seventy-seven thousand five hundred and fifty (77,550) patients who had been given custom-measured TES (both new users and recurrent users) were asked to complete a questionnaire. In all cases, the TES were prescribed to the patients by a medical doctor. The questionnaires were sent out via e-mail. The patients received one e-mail, and the questionnaire was voluntary. The questionnaire contained 10 questions, each with a qualitative ordinal scale. Patients were asked to score their satisfaction with the various aspects on a scale of 0 to 10. With a population size of 1.5 million patients (380,000 annually) who were given TES during the study period and a confidence level of 99%, an error margin of 1% was determined. This expresses the number of random sampling errors in the results of a questionnaire. The results are presented in bar charts, frequency tables, and percentage distribution of responses in order to analyse the outcome measures.13 Results The response rate of this outcome study was 44%; 34,122 of the 77,550 patients completed the questionnaire. Completeness of completed lists allows all information to be used. Table 1 shows the demographic data of the research population. Of the respondents, 67% is between 30 and 70 years of age, 30% is 70 years of age or over. These patients (total) are among the daily active people. The majority of the respondents in this study (59%) are women. The results are presented below. Do you wear the stockings? For the first question about compression therapy compliance (‘do you wear the stockings’), 96% of customers indicated that they actually wear the stockings. (Figure 1) 4% Of respondents indicated they do not wear the TES. During the study period, this score improved somewhat in terms of %, and the number of customers not wearing the stocking has decreased by 20%. Have you experienced an improvement since wearing the stockings? 63% answered ‘yes’ to this question. (Figure 2) 31% Experienced symptoms stabilizing and not worsening. The number of customers who indicate they do not experience any improvement is 5%, this decreased during the study period from 11% in 2017 to 4% in 2020. In table 2, the outcomes have been specified into type of aid and medical indication. There is a difference between the respondents who improvement on first dispensing (65%) and repeat dispensing (63%). However, there is a difference between the group that experienced no improvement when TES was dispensed for the first time (8%) and repeat dispensing (3%). A similar effect was experienced by respondents with the indications CVI (65%), thrombosis (63%), varices (63%). In respondents with lymphedema, a reduced effect was indicated, with 53% experiencing improvement. However, the group not experiencing any effect is equal. Fluid accumulation was not reduced as desired in 34% of cases. In addition, there is sometimes insufficient reduction of tiredness (19%) and restlessness and cramps (10%). How satisfied are you with the wearing comfort, fit, and ease of use The perceived wearing comfort of the stocking is rated 8.2 out of 10 by the respondents. The study results show a slight improvement over the study period. 43% of respondents rates the fit a 9 or 10 out of 10, and 10% rates it a 6 out of 10 or lower. The perceived fit was rated 8.4 out of 10 by respondents. The study period showed an annual improvement in the rating, from 8.1 out of 10 in 2017 to 8.6 out of 10 in 2020. The group of respondents who rate the fit a 9 or 10 out of 10 is 50%, whereas this was 40% in 2017, with this group increasing to 57% of respondents in 2020. Ease of use was rated 8.1 out of 10. The number of customers who rate the ease of use a 9 or 10 out of 10 increased from a score of 7.9 out of 10 in 2017 to a score of 8.3 out of 10 in 2020. Discussion Therapy compliance with wearing TES is stable throughout the duration of the study period, and at a high level: 96%. In total, 4% of respondents indicated they do not wear the TES. 5% of the respondents indicated they did not notice any difference in their symptoms. A causal relationship between the above is plausible. Symptoms were reduced by 63%. Customers with symptoms that did not (sufficiently) decrease were asked about the nature of the symptoms. In general, it can be said that certain symptoms do not always disappear completely with the use of TES. It is important there is consideration for the nature of the problem, the duration of the symptoms, and the TES indication.One example of this is the PTS (post-thrombotic syndrome). The group with a PTS indication and lymphedema indication also shows the lowest percentages of reduction in symptoms. The largest group of respondents is the group with CVI. This group of respondents also reports a high percentage of reduced symptoms (65%). A striking result is that 35% of the respondents indicates that the edema has not reduced sufficiently. The primary function of a TES is not to reduce edema, but to consolidate it. A TES should be measured over an edema-free limb. If necessary, wraps should be applied first. The outcomes of this study into the wearing comfort (8.1) and ease of use (8.2) confirm the policy for the provision of TES in the Netherlands. With correct instruction and provision of application aids, a high level of wearing comfort and ease of use can be achieved.14 The response rate among the respondents was 44%. The average response rate for e-mail questionnaires fluctuates between 25% and 33%.15 The questionnaire was sent once and no reminder was sent. A reminder of the questionnaire could possibly have yielded even more respondents. The study design asks which complaints have not sufficiently reduced yet. It would be a good addition to ask in a subsequent study which complaints did in fact reduce sufficiently and link this to the indication. This would enable better identification of which symptoms are most improved per indication. As yet, PROM studies into TES play a secondary role in the improvement of compression therapy. Only a limited number of studies have been published on the efficacy of TES in several indications.16,17,18,19,20,21 This PROM study is intended to be complementary to the literature currently available. The literature review revealed a shortage of PROM studies. These are necessary to create more evidential value and adds to the available literature. The literature often casts doubt on compression therapy compliance. A common argument put forward concerns the difficulty of application. For example, Kortanje (1990) poses that more than half of patients do not use the stocking.22 This study proves otherwise. Therapy compliance is high and the ease of use is rated a high 8.1 out of 10 too. Conclusion Outcomes of the PROM study confirm that the customer’s help request matches the chosen device. The results of this large-scale PROM study into TES show that the use of TES contributes to the reduction of the symptoms (63%) and therefore increases the general daily functioning. Reduced symptoms mean that patients can move more easily with less pain, so that they can lead more active lives and have a better quality of life. The results show that TES can be used effectively in different indications. Unfortunately, little is known - from a scientific perspective - about the perceived use of TES, and which wearing instructions and consideration are evidence based when recommending TES. We hope this study contributes practical advice related to this topic that professionals can use in the management of patients’ expectations in daily practice. References Dutch National Health Care Institute:www.gipdatabank.nl, consulted on 20 May 2021 Berszakiewicz A, Sieroń A, Krasiński Z, Cholewka A, Stanek A. Compression therapy in venous diseases: current forms of compression materials and techniques. Postepy Dermatol Alergol. 2020 Dec;37(6):836-841. doi: 10.5114/ada.2019.86991. Epub 2019 Jul 26. PMID: 33603599; PMCID: PMC7874882. Van der Veen N, Hulpmiddelenkompas: Guide to indicating, typifying, selecting, supplying and evaluating devices; Therapeutic elastic stockings section, first edition (pilot) of the College voor Zorgverzekeringen, 2002 - Amstelveen, Hulpmiddelenkompas 2002, Therapeutische elastische kousen, ISBN 90-70918-28-5. Ministry of Public Health, Wellbeing and Sport, De Kennisgemeenschap Hulpmiddelenzorg:www.hulpmiddelenzorg.nl, consulted on 25 May 2021 NHG guideline, Lymphedema Guideline, Multidisciplinary evidence-based guideline, version 01-05-2014 Burgstaller JM, Steurer J, Held U, Amann-Vesti B. Efficacy of compression stockings in preventing post-thrombotic syndrome in patients with deep venous thrombosis: a systematic review and metaanalysis. Vasa. 2016;45(2):141-7. doi: 10.1024/0301-1526/a000508. PMID: 27058800. Ten Cate-Hoek A. Efficacy of compression for the prevention of post-thrombotic syndrome: an unsolved clinical conundrum Comment on Burgstaller et al, p. 141 - 147. Vasa. 2016;45(2):85-6. doi: 10.1024/0301-1526/a000502. PMID: 27058794. Berszakiewicz A, Sieroń A, Krasiński Z, Cholewka A, Stanek A. Compression therapy in venous diseases: physical assumptions and clinical effects. Postepy Dermatol Alergol. 2020 Dec;37(6):842-847. doi: 10.5114/ada.2019.86990. Epub 2019 Jul 26. PMID: 33603600; PMCID: PMC7874878. Dutch National Health Care Institute: www.zorginzicht.nl/ondersteuning/prom-wijzer, consulted on 5 June 2018 Dutch National Health Care Institute, PROM toolbox,www.zorginzicht.nl/ kennisbank, consulted on 5 June 2018 O’Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. MHPE standards for reporting qualitative research. Academic Medicine 2014; 89: 1245–1251. Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013;6:61-68. Published 2013 Aug 4. doi:10.4137/HSI.S11093 O’Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. MHPE standards for reporting qualitative research.Academic Medicine 2014; 89: 1245–1251. SEMH, Branche specifieke eisen Therapeutisch Elastische Kousen (TEK) (inclusief aan- en uittrekhulpmiddelen), 2011 Good Survey Response Rate, QuestionPro, Dallas, USA. 2021/12/21,www.questionpro.com, consulted on 1 March 2021. Berszakiewicz A, Sieroń A, Krasiński Z, Cholewka A, Stanek A. Compression therapy in venous diseases: current forms of compression materials and techniques. Postepy Dermatol Alergol. 2020 Dec;37(6):836-841. doi: 10.5114/ada.2019.86991. Epub 2019 Jul 26. PMID: 33603599; PMCID: PMC7874882. Perrin M, Eklöf B. Does prescription of medical compression prevent development of post-thrombotic syndrome after proximal deep venous thrombosis?Phlebology. 2016 Apr;31(3):160-9. doi: 10.1177/0268355515585437. Epub 2015 May 5. PMID: 25944460. Eekhof, J. Voetloze steunkousen: meer onderzoek nodig. Huisarts Wet 60, 630 (2017). https://doi.org/10.1007/s12445-017-0395-y Partsch H, Flour M, Smith PC; International Compression Club. Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under the auspices of the IUP. Int Angiol. 2008 Jun;27(3):193-219. PMID: 18506124. Rabe E, Partsch H, Hafner J, Lattimer C, Mosti G, Neumann M, Urbanek T, Huebner M, Gaillard S, Carpentier P. Indications for medical compression stockings in venous and lymphatic disorders: An evidence-based consensus statement.Phlebology. 2018 Apr;33(3):163-184. doi: 10.1177/0268355516689631. Epub 2017 Feb 22. PMID: 28549402; PMCID: PMC5846867. Rademaker A, Van den Brugge F, Willems P, Van Herwerden R. Compressiekousen kunnen zonder voet. Huisarts Wet 2017;60:626-9. M.J. Korstanje, H.A.M. Neumann, Compressietherapie door middel van elastische kousen, Ned Tijdschr Geneeskd.1990;134:799-3 Authors M. Geerlofs BSc, Consulent Therapeutisch Elastische Kousen, Huidtherapeut, Livit Orthopedie, Breda, mgeerlofs@livit.nl I. Sissingh, Scholing - en adviesbureau compressietherapie, ina@sissingh.nl J.W. van der Windt MSc, CEO Livit Orthopedie, Amsterdam, jwindt@livit.nl E.F. Mik, Directeur Zorg en Allianties bij Livit Orthopedie, Amsterdam emik@livit.nl
8 - therapeutic elastic stockings
elastic stockings Efficacy and therapy compliance of compression therapy with the use of therapeutic elastic stockings
Table 1: demographic information of the research population
Woman
Man
34.122
20,060
14.062
<30
Average age
69.0
69.9
71.2
First dispensing
,
Repeat dispensing
Figure 3; responses to the question about wearing comfort, fit, and ease of use
Figure 2: response to the question ‘have you experienced an improvement’ and if no ‘which symptoms have not reduced sufficiently’
Incidence
Yes
Not improved, yet stable
65%
Bacterial infection / erysipelas
71%
Inactivity edema
CVI healed ulcer
CVI with atrophy blanche
74%
CVI with lipodermatosclerosis
CVI with edema
64%
CVI with edema and mild skin change
CVI
Thrombosis with edema
Thrombosis without edema
Thrombosis
Primary varices with edema
Primary varices without edema
Secondary varices with edema
Secondary varices without edema
Varices
Post-traumatic
Lipo-lymphedema
Primary lymphedema
52%
Secondary lymphedema
54%
Lymphedema
53%
Post-thrombotic syndrome
No
Table 2: response to the question ‘have you experienced an improvement’ specified into type of aid and medical indication
In all cases SILVERSPLINTS appears to serve as a suitable support for joints, providing pain relief and freedom of movement.
Introduction Osteoarthritis (OA) is a clinical syndrome characterised by joint pain, stiffness and functional impairment. Osteoarthritis of the hand usually occurs in the carpometacarpal joint of the thumb (CMC-I, 21%), the proximal interphalangeal joints (PIP) and the distal interphalangeal joints (DIP, 35 %).⁹,¹⁰ In addition, 50% of patients with DIP involvement also have proximal interphalangeal (PIP) joint involvement.1 The prevalence and incidence of osteoarthritis are significantly higher for women and increase with age. The majority of people older than 55 years have radiological features of OA of the hand and/or wrist, with 20% experiencing clinical symptoms.2,3 Most patients report an increase in pain symptoms over a period of 2 years, but osteoarthritis of the hand does not always develop progressively. As the disease progresses, the grip strength begins to deteriorate. Mechanical factors such as abnormal loading of the joint (trauma), heavy labour, joint instability and obesity can increase the risk of OA. Symptoms of OA can be controlled by interventions aiming at self-management, avoiding excessive joint loading and by giving pain medication, corticosteroid injections in the joint and handtherapy.4,5 Orthosisfor OA are frequently used to decrease pain, minimize deformities, decrease inflammation, decrease stress to the joints, provide support for increased function and assist with joint stability.6,7 A silver ring splint (SILVERSPLINTS) can serve as a suitable support for the joint, providing pain relief. Wearing the SILVERSPLINTS restricts movement, preventing the joint from moving along its full range of motion.8,2,9 This study into patient-reported outcome measures (PROM) regarding SILVERSPLINTS for OA of the hand has the objective to measure the effectiveness of SILVERSPLINTS in daily life and validate the efficacy of using orthopaedic medical aids. Methods PROM research is a method for measuring health in terms of physical and/or mental well-being andfunctioning in daily life for patients. PROM studies about orthopaedic medical aids still play a minor role and only a limited number of studies have been published. The Dutch National Healthcare Institute made an online toolbox available10 which served as a guideline for the design of this study.11 In this study the following Patient Reported Outcomes (PRO) were defined: How has your overall daily functioning changed since you started wearing your SILVERSPLINTS? How have your pain symptoms changed since you started wearing your SILVERSPLINTS? To what extent do you have problems with any of the following activities on a normal daywith/without a SILVERSPLINTS: writing, buttoning clothes, holding a book while reading, picking up the phone, opening jars, household chores, lifting groceries, taking a shower or bath and getting dressed.12 Statistics To improve quality, information is needed about health prior to and after an intervention. In this study, we compare feedback from customers about function gained with and without a SILVERSPLINTS. As there are no comparable studies regarding to the effectiveness of orthopaedic aids, there are no standard or target values to use. Between October 2018 and June 2020, 2231 patients with OA were provided with SILVERSPLINTS and they were asked about the effectiveness of the splints 3 weeks after they first started wearing the splints. The questionnaires were sent by email. There was just one email sent to the patients and it was a voluntary questionnaire. The questionnaire contains 10 questions, each using a qualitative ordinal 5-point-scale in terms of limitations in performing a certain task or activity. Patients had to report limitations with and without using SILVERSPLINTS. Age and gender were asked as well. Descriptive statistics are the basic measures used to describe our survey data. They consist of summary descriptions of frequency and percentage response distributions, for measure of central tendency the mode is used.13 With a population size of 6.500 patients who started using SILVERSPLINTS in the Netherlands in the period concerned and a confidence level of 95% a margin of error is calculated of 3%. This expresses the amount of random sampling error in the results of a survey. All SILVERSPLINTS were provided by Livit Orthopedie, a Dutch provider of orthotic and prosthetic services and products. The SILVERSPLINTS are made by highly qualified silversmiths, who partner up with hand specialists to deliver custom pieces of medical aids. The diagnosis OA has been confirmed by a medical doctor (MD) for all patients. Diagnosis was mostly made on the basis of X-rays and / or MRIs, in some cases it was based on the experience of the MD. Patients throughout the Netherlands in various institutions, ranging from university hospitals and rehabilitation centers to nursing homes have been included in this study. As such the population of this study can be considered representative for users of SILVERSPLINTS in the Netherlands. Technical information SILVERSPLINTS were developed in 1985. SILVERSPLINTS are a combination of oval rings made of high‐quality sterling silver. This material combines adequate strength and rigidity with a nice cosmetic appearance. SILVERSPLINTS are custom-made from 925 silver, a hypoallergenic material with antibacterial properties. The material is durable and well protected from wear and tear. Silver does not block the skin, preventing excessive perspiration, with possible odors and skin rashes as a result. SILVERSPLINTS have no rough edges, allowing the patient to move their hand/fingers as freely as possible, without causing any skin irritation or pressure points. The thumb section of SILVERSPLINTS for the wrist/hand is optimally adjusted to the needs of the patient, allowing for pen grip, tweezer grip or key grip. SILVERSPLINTS are easy to clean, can be used in warm water and rarely cause any skin allergy. Results The response rate of this patient-reported outcome study was 38%, 850 out of the 2331 patients completed the questionnaire.All could be used.For this study, it can be determined that for 95% confidence,the results lie somewhere between the numbers -3% and + 3% of the outcome. Online Survey Response Rates vary greatly depending on the target audience and the nature of the research. The average response rate for e-mail surveys fluctuate between 25% and 33% (QuestionPro). Note that no reminder e-mails have been send to the patients in this study. Of the respondents 45% are 65 years or more, 85% are 50 years or more. These patients are in the range of daily active people. The age range also matches with the prevalence and incidence rates of OA, when the majority of people older than 55 years have radiological features of OA of the hand.The majority of the respondents in this study (94%) are women. The results are presented separately for each question asked. Overall daily functioning 76% of respondents reported that their overall daily functioning improved (some,significantly and very significantly improvement) after they started wearing their SILVERSPLINTS. 47% report that their functional status improved significantly to very significantly, in contrast to 24% who experiences no change or deterioration. No difference is reported between the use of a SILVERSPLINTS for the finger or hand or wrist. The improvement experienced in the finger is 77% and for the hand / wrist 75%. Pain reduction Pain reduction is the main reason for wearing or prescribing a wrist orthosis. A wrist orthosis immobilises, supports and stabilises the wrist. Theoretically, this should help to reduce the inflammatory process and relieve capsules and ligaments. This should lead to a reduction of pain symptoms. The study shows that the pain is less and the stress on the wrist is reduced. The group with SILVERSPLINTS shows an improvement in pain symptoms of 74%. 43 % reported that their pain symptoms have changed significantly to very significantly, in contrast to 26 % who experiences no change or an increase in pain. Again, nodifference is reported between the use of SILVERSPLINTS for thefingeror hand/wrist. Daily activities Several questions were asked concerned daily activities with different types of hand function and with different types of grip and use of fingers. The results show a major improvement, especially in activities with fine motor skills or the more open grip of the hand, for instance used for opening a jar or lifting groceries. For opening a jar the group of patients experiencing major problems without a SILVERPLINT decreased from 44% to 26% when using a SILVERSPLINT. Also the group of patients who were unable to open a jar decreased from 23% to 13%. This question was asked to get insight in a cylindrical grip with and without an aid. For lifting groceriesthe group of patients experiencing no problems or minor problems increased from 21% to 51% when wearing a SILVERSPLINT, which means this group has more than doubled. This question was asked to get insight in a hook grip and generating strength with and without an aid. To be able to use force with a hand, even when wearing an orthosis is an important finding. It is therefore stimulating to see the results of these activities when wearing the SILVERSPLINT. Activities requiring fine motor skills like writing, buttoning clothes and handling the phone show major improvements. The group of patients experiencing no problems or minor problems with writing increased from 34% to 60% when using the SILVERSPLINTS. Holding a pen means a patient can hold a small, thin object and uses it with fine motor skills. This question was asked to get insight in the pen grip with and without an aid. It seems the SILVERSPLINTs contributes positively to these skills. For Buttoning clothes the results are similar; as the group experiencing no problems or minor problems increased from 34% to 63% when using the SILVERSPLINTs, a major increase of 85%. This question was asked to get insight in the tweezer grip with and without an aid. With a SILVERSPLINT, more than half of the patients had no problems with operating orusing a mobile phone, a very important activity in modern life. Combining it with the group of patients with minor problems this percentages increases to 80 %. An open hand grip with SILVERSPLINTs improved as problems with holding a book as the group of patients who does not experience any problems increased from 17% to 42%, representing 147% increase. Table 1 shows the results when the patients with “no problems and minor problems” are combined in one group for each activity with and without using SILVERSPLINTS. Table 2 shows the results when the patients with “major problems or unable” are combined in one group for each activity with and without using SILVERSPLINTS. Discussion Wearing an orthosis for OA of the hand during periods of acute inflammation is designed to reduce joint friction and prevent excessive joint loading by reducing joint motion. Although critics of immobilization report that maintenance of normal tissues require movement, excessive mobilization of unstable arthritic joints can promote further instability. Several studies have reported that an orthosis decreases pain and increases function during daily activities in patients with arthritis.1,2,4,14 In this PROM study the overall daily functioning improved when wearing a SILVERSPLINT, reported by 76% of the patients. This was just three weeks after the patients started to wear the SILVERSPLINTS, which suggest that other beneficiary factors, such as hand therapy or medication did not contribute to this result. The study did not include registration of the use of pain medication, which might have influenced the results. It would be interesting to find out why 24 % of the patients did not experience improvement or even deterioration. Over the past decades, many surgical and non-surgical interventions have been developed to treat CPC-I osteoarthritis and OA of the hand, with non-surgical interventions such as splints and hand therapy being particularly common. The effectiveness of these interventions, however, was quite unknown due to sparse research and studies with varying outcomes. Tsehaie, affiliated with the Xpert Clinic and Rotterdam’s Erasmus MC, was the first to research the effect of these non-surgical interventions on a large scale, studying 809 patients with CPC-I osteoarthritis. On average, patients in this study reported feeling 39% less pain than before treatment (pain score from 90 to 55).15,16 In this study 74 % of the patients reported significantly or very significantly decrease in pain, when wearing SILVERSPLINTS for at least 3 weeks. However 20 % experienced no change. The follow up is short and since our study is a PRO study, no data is available concerning rejecting the SILVERSPLINTS in the group of patients who experiences deterioration of pain after wearing the SILVERSPLINT. The results show a major improvement in both the more open grip of the hand and activities requiring fine motor skills. To be able to use force with a hand, even when wearing an orthosis is an important finding. It is therefore stimulating to see the results of these activities when wearing the SILVERSPLINT. However some remarks must be made. It was not registered how many SILVERSPLINTS a patient was wearing, on which hand (dominant or not dominant) or which kind of SILVERSPLINT was used (for the fingers or wrist). These aspect could have an influence on functioning with the splints. The effect of the SILVERSPLINTS is measured after wearing the orthosis for three weeks, which means the effect starts quite quickly. This may provide support for the use of an orthosis in cartilage protection especially when an orthosis repositions and aligns the joint appropriately. It would be interesting to know if the improvement lasts over time. In a comparative study, SILVERSPLINTS rendered equal functional results compared to thermoplastic orthoses, whereas they were valued better on aspects of comfort and cosmetics.17,18,19,20,21 In this study patients were not asked to value this aspect. It would be interesting to ask, since the SILVERSPLINTS were custom made and small details could change the outcome of functioning with this orthosis. Conclusion The results of this large-scale PROM study into the effectiveness of SILVERSPLINTS for patients with OA of the hand show that the use of SILVERSPLINTS contribute to overall daily functioning, reduce pain and increase the possibilities to do daily activities.Deformities as a result of OA include a mallet finger deformity at the DIP joint and lateral deviation or boutonnière deformities at the PIP joint. Osteoarthritis of the CMC-I joint is usually associated with more functional impairments than PIP or DIP osteoarthritis. In all casesSILVERSPLINTS appears to serve as a suitable support for joints, providing pain relief and freedom of movement, but preventing the joint from moving along its full range of motion. The follow up in this study was short, it would be interesting to see if theimprovement of the SILVERSPLINTS in daily activities lasts over time. Livit Orthopedie is the Dutch premier provider of orthotic and prosthetic services and products. Providing customer care across The Netherlands with a network of 500 customer locations, 450 staff and 1 production location. References Kaufmann RA, Lögters TT, Verbruggen G, Windolf J, Goitz RJ.Osteoarthritis of the distal interphalangeal joint. J Hand Surg Am. 2010 Dec;35(12):2117-25. doi: 10.1016/j.jhsa.2010.09.003. PMID: 21134619. Kalichman L, Hernández-Molina G. Hand osteoarthritis: an epidemiological perspective. Semin Arthritis Rheum. 2010 Jun;39(6):465-76. doi: 10.1016/j.semarthrit.2009.03.001. Epub 2009 May 31. PMID: 19482338. Fumagalli M, Sarzi-Puttini P, Atzeni F. Hand osteoarthritis. Semin Arthritis Rheum. 2005 Jun;34(6 Suppl 2):47-52. doi: 10.1016/j.semarthrit.2004.03.014. PMID: 16206958. Alison Hammond PhD, MSc, BSc(Hons), Jane Burridge PhD, Grad Dip Phys, Cyrus Cooper MA, MBBS, DM, FRCP, FFPH, FMedSci. Static orthoses in the prevention of hand dysfunction in rheumatoid arthritis: a review of the literature Muskeleton Care, 06 January 2006 Wouters RM, Tsehaie J, Slijper HP, Hovius SER, Feitz R; Hand-Wrist Study Group, Selles RW. Exercise Therapy in Addition to an Orthosis Reduces Pain More Than an Orthosis Alone in Patients With Thumb Base Osteoarthritis: A Propensity Score Matching Study. Arch Phys Med Rehabil. 2019 Jun;100(6):1050-1060. doi: 10.1016/j.apmr.2018.11.010. Epub 2018 Dec 11. PMID: 30543802. Fess E.E., Gettle K.S., Philips C.A., Janson J.R., Hand and Upper Extremity Splinting Principles and Methods. 3rd ed. Elsevier, St. Louis, MO2005 Biese (Beasley) J., Arthritis, Cooper C. Fundamentals of Hand Therapy: Clinical Reasoning and Treatment Guidelines for Common Diagnoses of the Upper Extremity. Elsevier, St. Louis, MO2007: 348-375 Gomes Carreira AC, Jones A, Natour J. Assessment of the effectiveness of a functional splint for osteoarthritis of the trapeziometacarpal joint on the dominant hand: a randomized controlled study. J Rehabil Med. 2010 May;42(5):469-74. doi: 10.2340/16501977-0542. PMID: 20544159. Ikeda M, Ishii T, Kobayashi Y, Mochida J, Saito I, Oka Y. Custom-made splint treatment for osteoarthritis of the distal interphalangeal joints. J Hand Surg Am. 2010 Apr;35(4):589-93. doi: 10.1016/j.jhsa.2010.01.012. PMID: 20353860. PROM-toolbox,ttps://www.zorginzicht.nl/ kennisbank/ paginas/prom-toolbox.aspx NIVEL, IQ healthcare, VSOP, Patiëntenfederatie Nederland, ZN, https://www.zorginzicht.nl/ontwikkeltools/ prom-toolbox/prom-wijzer-4.-lokaal- landelijk-of-internationaal RIVM Institute for Public Health and the Environment; Volksgezondheidenzorg.info National Registry of Orthopedic Implants, https://www.nvpc.nl/uploads/nummer_file/ file-161NTPC_2014__5(2)_p70-3_Smits.pdf O’Brien, Bridget C. PhD; Harris, Ilene B. PhD; Beckman, Thomas J. MD; Reed, Darcy A. MD, MPH; Cook, David A. MD, MHPE Standards for Reporting Qualitative Research, Academic Medicine: September 2014 - Volume 89 - Issue 9 - p 1245-1251 doi: 10.1097/ACM.0000000000000388 Beasley J. Osteoarthritis and rheumatoid arthritis: conservative therapeutic management. J Hand Ther. 2012 Apr-Jun;25(2):163-71; quiz 172. doi: 10.1016/j.jht.2011.11.001. Epub 2012 Feb 11.PMID: 22326361. Tsehaie J, Spekreijse KR, Wouters RM, Slijper HP, Feitz R, Hovius SER, Selles RW.Outcome of a Hand Orthosis and Hand Therapy for Carpometacarpal Osteoarthritis in Daily Practice: A Prospective Cohort Study.J Hand Surg Am. 2018 Nov;43(11):1000-1009.e1. doi: 10.1016/j.jhsa.2018.04.014. PMID: 29776723. Tsehaie J, Spekreijse KR, Wouters RM, Slijper HP, Feitz R, Hovius SER, Selles RW.Outcome of a Hand Orthosis and Hand Therapy for Carpometacarpal Osteoarthritis in Daily Practice: A Prospective Cohort Study.J Hand Surg Am. 2018 Nov;43(11):1000-1009.e1. doi: 10.1016/j.jhsa.2018.04.014. PMID: 29776723. Ter Schegget MJ, Knipping AA.The swanneck splint in rheumatoid arthritis. Ned TijdschrErgotherapie 1997; 25: 172–82. Lapeer GL, King RE. The sterling silver splint as a treatment modality for craniomandibular problems. Cranio. 1987 Apr;5(2):164-9. doi: 10.1080/08869634.1987.11678187. PMID: 3471357. Wilder FV, Barrett JP, Farina EJ. Joint-specific prevalence of osteoarthritis of the hand. Osteoarthritis Cartilage. 2006 Sep;14(9):953-7. doi: 10.1016/j.joca.2006.04.013. Epub 2006 Jun 8. PMID: 16759885. Christie A, Jamtvedt G, Dahm KT, Moe RH, Haavardsholm EA, Hagen KB. Effectiveness of nonpharmacological and nonsurgical interventions for patients with rheumatoid arthritis: an overview of systematic reviews. Phys Ther. 2007 Dec;87(12):1697-715. doi: 10.2522/ptj.20070039. Epub 2007 Sep 25. PMID: 17906290. Wouters RM, Slijper HP, Esteban Lopez L, Hovius SER, Selles RW; Hand-Wrist Study Group. Beneficial Effects of Nonsurgical Treatment for Symptomatic Thumb Carpometacarpal Instability in Clinical Practice: A Cohort Study. Arch Phys Med Rehabil. 2020 Mar;101(3):434-441. doi: 10.1016/j.apmr.2019.08.485. Epub 2019 Oct 11. PMID: 31610153. Authors Nienke Roux, Medical Docotr, Basalt, Vrederustlaan 180, 2543 SW, Den Haag, The Netherlands. Jan Willem Van der Windt, CEO Livit Orthopedie, Amsterdam Wouter Akkermans, Director Operational Management at Livit Orthopedie, Dordrecht Marco Toor, CPO and regional manager at Livit, Den Haag
Between '18 and '21, 2231# patients with silversplints were asked to complete a questionnaire. The response rate of this outcome study was 38%;
Pain, stiffness and joint deformity may cause a serious decrease in hand function for people with osteoarthritis (OA). Characteristic finger deformities in OA are swan neck deformity and boutonnière deformity. Several studies have reported that an orthosis decreases pain and increases function during daily activities for patients with arthritis. The purpose of this article was to review the patient reported outcome of current conservative therapeutic management with silver ring splints (SILVERSPLINTS) for patients with osteoarthritis of the hand. The results show an improvement in overall daily functioning of 76 % and in reduction of pain of 74 %.
silversplints Patient reported outcome of silversplints used for osteoarthritis of the hand.
9 - SILVERSPLINTS
Figure 2: example of SILVERSPLINTS of the finger (source: Livit Silversplint Catalogue)
Wears like a jewel
Figure 1: example of SILVERSPLINTS of the hand (source: Livit Silversplint Catalogue)
correct, stabilise or immobilise the wrist, hand, and/or finger
The Dynamics Sterling line of silver orthoses gives users complete freedom and comfort and all orthoses can be worn as a piece of jewellery. Our dynamic silver orthoses are custom-made from 925 silver, a hypoallergenic material. We only use highly pure Sterling 925 silver in our orthoses, which has hypoallergenic and antibacterial properties. Silver does not block the skin, preventing excessive perspiration and the possible odours and rashes that this can result in. Unlike silicone or leather orthoses, a silver orthosis can be worn as a piece of jewellery. Our orthoses can be finished according to your personal preferences and come in polished or matt silver, for instance. Our silver department only works with highly qualified goldsmiths and silversmiths, who partner up with our hand specialists to deliver perfect, beautiful and custom pieces of jewellery.
Open design helps comfort
SILVERSPINTS
Figure 4: Results of question: How have your pain symptoms changed since you started wearing your silversplint?
Figure 3: results of question: How has your overall daily functioning changed since you started wearing your silver splint?
Activity
Activity level without aid
(a) no problems
(b) minor problems
(a+b) Total*
112%
80%
150%
Householdchores
243%
143%
73%
Activity level with aid
Change **
(c) no problems
(d) minor problems
(c+d) Total*
76%
85%
Table I: Improvement in functional status according to activity type.
Figure 5: Results of questions related to daily activities.
Table II: function status improvement per activity type
(a) major problems
(b) unable to perform
-73%
-42%
-67%
-58%
-56%
(c) major problems
(d) unable to perform
-59%
-61%
ADAPT-IT
A major advantage of 3D printing is the freedom it gives to designers, as it eliminates virtually all restrictions with regard to manufacturing or processing. This creates myriad ways to add new properties to the end product, such as unique shapes and applications which would have been simply impossible with traditional socket technology. 3D printing also makes it easier to improve key product features, e.g. by making maximum use of porosity and improving the ergonomic and anatomical fit of sockets. In this article an improved prosthetic socket for connection to a lower limb prosthesis is presented. The concept allows adjusting the shape of the inner side wall. By providing an adjustment mechanism, the positions of at least two wall portions of the inner side wall can be set in accordance with the shape and/or size of the stump. It is then no longer necessary to design and manufacture a new socket to adapt to varying sizes of the stump.
Introduction A leg prosthesis consists of various parts, one of which is the socket. The socket supports the body’s weight, distributes pressure over the stump and serves as a foundation for the rest of the prosthesis. Each amputation level requires a different degree of socket pressure and in some cases, there may even be several options for one and the same amputation level. When determining the overall concept of a prosthetic limb, it is also important to carefully consider what type of socket to use, as choosing the right prosthetic socket is essential for a comfortable life with an amputation. In practice, we see that many people experience pressure and movement-related problems with their socket, resulting from stump volume change. Until now, these problems were often solved by selecting the appropriate liner and using stump socks to mitigate pressure problems and volume changes.[i],[ii] Now, however, a new technology will solve these problems once and for all: patented 3DP Volume Adaptive Socket Technology for transtibial amputations. In 2018 the engineering team of Livit joined forces with lower-leg amputation experts (CPO’s) to devise, develop, test, and fine-tune a new type of prosthetic socket that redefined socket technology. Later that year, we obtained a patent for our unique volume-adaptive 3DP socket technology: ADAPT-IT. Since then, we have partnered up with referring physicians to fine-tune the concept and its implementations in various phases. In 2019, the prototype of the ADAPT-IT was tested for the first time, with the first user experiences exceeding our wildest expectations. With the ADAPT-IT, prosthesis wearers had more control over the volume of their sockets wherever, whenever, enabling them to achieve an ideal fit both at rest and in more active scenarios, without having to wear stump socks. The design freedom offered by 3DP has redefined socket technology, leading to an end result that has brought us one step closer to normal control of movement. With the ADAPT-IT, prosthesis wearers can regain control over pressure distribution in their sockets anywhere and at any time, enabling them to achieve an ideal fit both at rest and in more active scenarios without requiring stump socks or extra sockets. In this article, we will delve deeper into the problems that can occur due to stump volume change when wearing a prosthesis, as well as how 3D printing can be used to solve this problem and how the ADAPT-IT was developed. Background Every year, more than 3,000 trans-tibial amputations are performed in the Netherlands, representing an incidence of 18.5 to 19 per 10,000 persons.[iii] Of these 3,000 leg amputations, almost 50% are at the transtibial level, with a smaller number at the transfemoral level. Younger patients are more likely to be prescribed a prosthetic limb, whereas only 48% of older people is referred to have a prosthesis made. Primary reasons for amputation are peripheral vascular disease (95%), but amputation as a result of trauma (4%) and cancer (1%) also occur.[iv] After amputation, optimal patient prosthesis satisfaction, for example in regaining ambulation, is a major goal in the prescription of lower limb prostheses.[v] In the past, primitive prostheses were fabricated from wood and metal with few moving parts. These prostheses were heavy and fitted poorly to the residual limb, resulting in limited functioning with the prosthesis.[vi],[vii] With advanced technologies and introduction of new materials, for example silicon liners[viii],[ix] prosthesis fit and functioning with the prosthesis improved. However, prosthesis satisfaction is often not achieved to full potential. Many patients experience pain in residual limb during prosthesis use and are not satisfied with the comfort of the prosthesis socket.[x][xi] Osseointegration, or bone-anchored limb prosthesis, is an alternative that makes the socket possibly obsolete.[xii],[xiii] But this technique is not suitable for most patients and a majority of the persons with an amputation still use a prosthesis socket for fixation of the prosthesis to the residual limb.[xiv] The importance of fit and fixation A good prosthesis fit is a prerequisite for functioning with a prosthesis and an important goal in prosthetic care of persons with a trans-tibial amputation.[xv][xvi] Prosthesis socket fit is not clearly defined in literature. A good prosthesis socket fit, or biomedical fit, ensures adequate fixation of the prosthesis to the residual limb. Expert opinions and case reports indicate that the medical fit should be comfortable and maintain the integrity of the residual limb tissues including skin, muscles, blood vessels and nerves while the prosthesis is worn and used. Furthermore, the biomedical fit allows for adequate knee range of motion while performing activities such as cycling and climbing stairs. Sometimes, patients will experience stump problems, which can have a significant impact on their life, ranging from irritated skin to bone or nerve overgrowth. 34-63% of patients wearing a prosthesis experience annoying superficial skin problems on their stump.[xvii]In addition, a significant proportion of patients suffer from stump pain, which is usually the result of a poorly fitting prosthetic socket.[xviii][xix][xx]In people with a trauma-related amputation, more than half of them is dissatisfied with the comfort of the prosthesis for and almost 25% report skin irritation and wounds. When either of these two problems occur, wearers will typically be temporarily unable to wear their prosthetic limb, which has a negative impact on their independence, mood, and quality of life. with many patients opting to wear a prosthetic limb afterwards. Because the socket connects the body to the prosthesis, it is essential that the socket fits like a glove and is properly fixed in place. A good fit will help distribute pressure on the stump, while the level of fixation of the socket will determine how much the stump can move inside the socket. When designing the prosthetic concept and selecting a socket based on the shape of the customer’s stump, there are many different shapes and materials to choose from, with the choice ultimately depending on the customer’s lifestyle and physical condition. The advantages of a well-fitting, well-fixed socket include: limited intra-socket movement, reducing irritation, boosting comfort, and improving stump skin health. Good pressure distribution in the socket. Good control over your prosthetic limb. Factors supposed to influence prosthesis fit have been described in literature only in general terms and studied fragmentarily and to a limited extent, giving an insufficient base for a systematic and comprehensive assessment of prosthesis fit. [xxi],[xxii],[xxiii],[xxiv], [xxv],[xxvi],[xxvii] Between 40 to 60% of people with an amputation is not satisfied with their prostheses. Of these persons, 75% is dissatisfied with the comfort and over 50% reports pain while using their prostheses. Factors related to dissatisfaction with the prosthesis are: displeasing appearance, poor function, a prosthesis that is to heavy and an inadequate socket fit resulting in residual limb discomfort and pain. Dissatisfaction of the prosthesis can ultimately result in rejection of the prosthesis, which may occur in up to 30% of prostheses prescribed in some patient groups.7Hence, prosthesis (dis)satisfaction is a highly relevant issue in the care of persons with a lower limb amputation. Volume changes and fit: It is important that the prosthetic socket fits snugly around the stump. [xxviii] The volume of the stump may change over the course of the day, which could be detrimental to the fit of the socket. Some causes of stump volume change are: Moisture retention or loss, possibly effected by ambient temperature. In addition, various medical conditions, such as diabetes and renal failure, can also have a negative effect on stump volume stability.17Increase or decrease in body weight, often over an extended period of time. High activity levels, exercise, an active lifestyle - e.g. a 10km walk. Stump atrophy, which will happen to all stumps over time. As the stump loses muscle and other tissue, it will become more bony and slimmer. These volume changes can cause the socket to fit less snugly, which can lead to stump problems.[xxix] Until now, volume reductions and the resulting pressure in the socket could only be compensated by fitting the socket with a liner or combining one with stump socks. Multiple stump socks often come with a new stump socket, which can be a time-consuming process.[xxx] results - Development and use of a Volume Adaptive Prosthetic Socket for trans-tibial prostheses 3DP used for new socket technology By developing new products, we hope to bring about improvements in four key areas: freedom of movement, identity, awareness, and greater comfort and ease of use. The introduction of digital production methods, with 3D milling models, and 3D printing have greatly increased the options available to us in our range of orthopaedic aids, opening up a whole new world for rehabilitation care and orthopaedic consultants. These technological innovations have given a tremendous boost to the creative process, resulting in a volume-adaptive trans-tibial socket that can compensate volume changes whilst being fully adjustable. This new socket will increase customers’ mobility and comfort and open up new treatment methods for patients who did not have access to these methods before. Volume Adaptive Sleeve Technology Volume Adaptive Sleeve Technology is a form of personalised adjustability, allowing users to tailor their aids to their personal needs based on real-time feedback. In the orthopedic aid industry, adaptive technology is already a well-known term, especially when it comes to prosthetic knees. Just take Auto-Adaptive Knees, for example. However, adaptive technology and its applications are not as well-known in the socket technology sector, and the associated suspension systems. An adaptive technology application would be a very welcome addition, as it would allow us to continue to provide our customers with the right orthopedic aids in a changing healthcare landscape. A prosthetic socket that is able to adapt to its wearer will significantly increase freedom of movement, enabling them to walk, cycle, sit down, or perform any other action more easily than ever before. With an adaptive socket, the user could tailor their socket to their every need, which has many advantages: it puts people back in control over their own mobility. It can be introduced at an early stage of the rehabilitation process. Adaptive sockets can be used for a longer period of time without interim checkups and adjustments. Adaptive sockets can mirror the customer’s growth during the rehabilitation process. Dynamic system Volume adaptive socket technology literally enables users to tailor their prosthetic socket to the volume required at a certain point in time or in a certain situation.Adaptive socket technology is based on real-time user feedback and the possibility to directly convert this feedback into an adaptation in the socket’s volume. This new technology can do much more than traditional socket technology. Volume adaptive technology enables highly personalised prosthetic limbs, providing customers with prosthetic sockets that suit their personal goals and skills. Freedom of form and customisation with 3DP A major advantage of 3D printing is the freedom it gives to designers, as it eliminates virtually all restrictions with regard to manufacturing or processing. This creates myriad ways to add new properties to the end product, such as unique shapes and applications which would have been simply impossible with traditional socket technology. 3D printing also makes it easier to improve key product features, e.g. by making maximum use of porosity and improving the ergonomic and anatomical fit of sockets. The present invention relates to a prosthetic arranged for connection to a lower limb prosthesis, wherein the prosthetic socket comprises a receptacle for receiving a stump of a patient, wherein the receptacle comprises a bottom for receiving a distal end of the stump and an inner 5 side wall for at least partially enclosing said stump. The invention further relates to a method for manufacturing such a prosthetic socket. For connecting a lower limb prosthesis to a patient, a prosthetic socket is typically used. The socket is arranged on the stump and connects to the actual prosthesis, for instance an artificial lower leg or lower arm. Such a socket typically has receptacle, for instance having a cuplike shape, wherein the bottom of the cup is arranged for receiving the stump of the patient. This limits relative movement in the distal direction. The inner side wall of the cup extending from the bottom is designed to prevent any lateral movement of the stump. The shape of the cup or receptacle is designed to closely match the anatomy of the stump of the patient to prevent or at least reduce any relative movement between the stump and the socket. It is known fabricate a socket by making a cast of the amputee's residual limb. The socket, specifically the receptacle thereof, can then be shaped to closely fit the shape of the cast. As an alternative, the socket can be designed using three dimensional imaging techniques. The socket, in particular the receptacle thereof, can for instance be designed by computer aided design based on three dimensional image data obtained by medical imaging. To fabricate the socket based on the design, a three dimensional printing technique may be used. A further improved prosthetic socket with volume adaptivity To provide a further improved prosthetic socket, the prosthetic socket is arranged for connection to a lower limb prosthesis, wherein the prosthetic socket comprises a receptacle for receiving a stump of a patient, wherein the receptacle comprises a bottom for receiving a distal end of the stump and an inner side 5 wall for at least partially enclosing said stump, characterized in that the inner side wall is defined by a plurality of wall portions and wherein the prosthetic socket comprises an adjustment mechanism for adjusting the relative position of the wall portions.[xxxi] The concept (of the inner side wall) allows adjusting the shape of the inner side wall. It has been found that the size of stump, in particular in a transverse plane, i.e. a plane perpendicular the longitudinal axis of the stump, varies over time. By providing an adjustment mechanism, the positions of at least two wall portions of the inner side wall can be set in accordance with the shape and/or size of the stump. It is then no longer necessary to design and manufacture a new socket to adapt to varying sizes of the stump. The invention is specifically advantageous for use in a lower limb prosthesis.A socket for a lower limb needs to be applied to a stump having relatively hard tissue compared to for instance upper limbs. These limbs tend to have more fat or muscle tissue onto which a socket can be clamped. Fitting a socket to relative stiff tissue requires a tighter fit of the socket. The wall portions are movable in a direction having a component in the radial direction, seen with respect to the longitudinal axis of the stump. By moving the wall portions in the transverse plane, changes in shape and/or size of the stump in this plane can be compensated for. In order to compensate for changes in diameter or perimeter of the stump, which are most critical, the adjustment mechanism is arranged for adjusting a diameter or perimeter of the inner side wall of the receptacle according to a preferred embodiment. Preferably, the two wall portions, the relative position of which is adjustable, extend at different positions along the diameter of the receptacle. This allows an efficient adaptation. The size of the stump may change locally. In order to compensate for local variations in size, it is preferred if the adjust mechanism is arranged to adjust the position of a plurality of wall portions. The respective wall portions, arranged to engage respective locations of the stump, can then be adjusted accordingly. The inner side wall is typically designed to have a good fit to provide a stable connection for the receptacle. The inner side wall may thereto extend along the complete perimeter of the stump. This is however not necessary. The inner side wall is formed from a plurality of separate wall portions which together enclose the stump in the transverse plane for a stable fit. This improves the comfort for the wearer of the socket. Seen along the perimeter, spaces may extend between the wall portions. An efficient and comfortable socket is obtained when the two wall portions extend at approximately diametric opposite locations of the inner side wall. Adjust for daily changes It was found that the size of the stump not only changes gradually over time, but also within day or even within a day. To be able to adjust for these changes, it is preferred if the adjustment mechanism is manually operable, for instance using a knob. The user can thus adjust the position of the wall portions, for instance adjust the diameter of the inner side wall of the receptacle.[xxxii] The adjustment mechanisms may for instance limit the movement of the wall portions in a direction radially outward. Movement inwardly is then limited by the stump. The wall portions, preferably extending along the perimeter of the stump, may for instance be connected using a connecting member. By adjusting the length of the connecting member, the relative position of the wall portions can be adjusted. The connecting member may for instance comprise a tensioning member such as a cable or strip. The connecting member extends around the perimeter of the inner side wall or the receptacle, thereby defining the maximum diameter. The connecting member extends around or along the wall portions. The diameter is then determined at the locations of the wall portions, i.e. the parts for stably contacting the stump. An easy to use system is obtained by the adjustment mechanism further comprises a turning knob for adjusting the length of the connecting member. In order to efficiently receive the connecting member, it is preferred if the receptacle comprises at least one channel for receiving the connecting member. In order to allow an efficient movement of the wall portions for adjusting to a varying size of the stump, the socket comprises of at least one flexible section interconnecting a wall portion to the bottom. The wall portion, or any part comprising the wall portion, is then flexibly attached to the bottom, thereby allowing a relative movement of the wall portion. The wall portion may be movable with respect to the bottom and any wall portion fixedly connected to said bottom. The flexible section is arranged to allow movement of the wall portions in a radial direction, seen with respect to the longitudinal axis of the stump, which is substantially perpendicular to the surface of the bottom. This allows adjustment of the wall portion to varying size in respect of diameter of the stump. The flexible section may comprise a hinge or other type of joint. The socket comprises a plurality of fin shaped members connected to the bottom, wherein the inner surfaces of the fin shaped members comprise the wall portions. The fin or wing shaped members extend under an angle with respect to the bottom, thereby forming a cup shaped receptacle for the stump. Preferably, the fin shaped members are connected to the bottom using a flexible section as mentioned above. This allows efficient movement of the fin shaped members. An efficient configuration is obtained if fin shaped members extend radially from the bottom. The socket is hereby star shaped, with the bottom in the center and the fin shaped members extending radially therefrom. The proximal parts of the fin shaped member are bent upwardly, forming the cup as mentioned above. The fin shaped members are interconnected using the connecting member as mentioned above. According to a preferred embodiment, the connecting member extends between the fin shaped members at the location of the wall portions. The connecting member, for instance a cable, cord or strip, then limits any movement of the wall portions of the fin shaped members in a direction radially outwardly. ADAPT-IT®; The pressure distribution of the 3DP socket can be adjusted with one “click” based on stump volume changes over the course of the day. Patented design, this unique functionality is the result of a: Multi-blade, propeller-shaped collection system, a flexible connection with the base system; and a smart, adjustable closure with a mechanical dial and strong steel wire that can be used to tighten, secure, and loosen the system. (BOA system) With the new ADAPT-IT volume adaptive socket by Livit Orthopedie, prosthesis wearers can control pressure distribution in their socket wherever, whenever. Unique features of the Volume Adaptive Socket: Adaptive Volume; the pressure distribution of the 3DP socket can be adjusted with one “click”, based on stump volume changes, pressure, and compression. Lifelike feeling; patented 3DP socket technology achieves a level of pressure distribution that is very close to the feeling of ‘natural’ control. Control your clothes; the BOA dial can easily be adjusted through the fabric of the trousers. Say goodbye to extra stump socks; for the ideal fit. Quick on & off; the ‘quick release’ button will make it easier than ever to take your prosthetic socket on and off, even with big volume changes. Greater sitting comfort; by relieving pressure, the socket increases sitting comfort and does not restrict blood flow. Extra compression in active scenarios; by applying extra compression, you can now increase the pressure and restrict intra-socket movement without switching to a different socket or wearing extra stump socks, making exercise easier than ever before Discussion and conclusion Joint development The smart application and development of new technology begins with sharing and bundling knowledge and insight. Based on our experience with working in multidisciplinary healthcare teams, we have found that the various parties involved work together closely and share a lot of specialist knowledge with the aim of finding the best possible solution for the patient in question. We noticed that doctors and specialists shared our desire to continue exchanging ideas and knowledge outside these care teams, too, which prompted us to join forces with various partners and business associates to innovate and develop new products in the field of digital fitting and 3D prototyping. Our new volume adaptive socket technology is a great example of what this can lead to. We discussed and shared our prototypes and test models with revalidation physicians in various phases of the product development process. In the context of this cooperation, we shared knowledge with each other and explored new options and possibilities together in order to perfect the underlying concept and technology, based on our shared vision of making and keeping mobility possible, accessible, and affordable for the people who need it most. Why is there no volume adaptive socket yet? One of the reasons that there are no volume adaptive sockets available on the market yet is that the orthopedic aid industry is not yet sufficiently aware of part of the new possibilities offered by 3DP. That is why our designers are constantly looking to explore new product features and come up with innovative designs, based on what 3D printing technology can and cannot do. 3D printing can also be used to make incredibly lightweight products by giving them advanced internal structures, similar to a honeycomb. Product designs can also be made considerably more complex, featuring integrated parts without requiring complicated assembly processes for hybrid parts. Our current production methods are very restrictive in terms of design and are therefore not suitable for developing new systems and products. 3D printing can be an incredibly promising solution, as it allows us to print out objects in any shape we want, whenever we want, to meet our every wish. Ideas that were previously impossible to put into practice are now a realistic option, with new products being developed at a rapid pace. By working with 3D designers and engineers, we are now able to come up with innovative products and solutions of our own, too. This is what allowed us to develop our very own socket, featuring auto-adaptive technology. With 3D printing, we succeeded in developing a dynamic system that enables users to adjust their sockets based on the desired volume on the fly. Literature Van der Linde H, Hofstad CJ, Geurts AC, Postema K, Geertsen JH, van Limbeek J. A systematic literature review of the effect of different prosthetic components on human functioning with a lower-limb prosthesis. J Rehabil Res Dev 2004;41:555-70 Sewell P, Noroozi S, Vinney J. Andrews S. Developments in the trans-tibial prosthetic socket fitting process: a review of past and presenta research. Prosthet Orthot Int 2000;24:97-107 Rommers GM, Vos LD, Groothoff JW, Schuiling CH, Eisma WH. Epidemiology of lower limb amputees in the north of The Netherlands: aetiology, discharge destination and prosthetic use, Prosthet Orthot Int 1997; 21(2):92-99 Fortington LV, Rommers GM, Postema K, van Netten JJ, Geertzen JH, Dijkstra PU.Lower limb amputations in Northern Netherlands; unchnaged incidence from 1991-1992 to 2003-2004. Prosthet Orthot Int 2013;37(4):305-310 Kark L, Simmons A, Patient satisfaction following lower-limb amputation: the role of gait deviation. Prosthet Orthot INt 2011:35:225-233. Van der Meij WKN. No leg to stand on. Historical relation between amputations surgery and prostheseology. University of Groningen Thesis 1995. Laferrier JZ, Gailey R. Advances in lower-limb prosthetic technology. Phys Med Rehabil Clin N Am 2010;21(1):87-110 Kristinsson O. The ICEROSS concept: a discussion of a philosophy. Prosthet Orthot Int 1993:17:49-55 Hachisuka K, Nakamura T, Ohmine S, Shitama H, Shinkoda K. Hygiene problems of the residual limb and silicone liners in transtibial amputees wearing the total surface bearing socket. Arch Phys Med Rehabil. 2001;82:1286-90 Medline. Berke GM, Fergason J, Milani JR, Hattingh J, McDowell M, Nguyen V. Comparison of satisfaction with current prosthetic care in veterans and service members from Vietnam and OIF/OEF conflicts with major traumatic limp loss JRRD2010;47(4):361-371 Dillingham TR, Pezzin LE, MacKenzie EJ, Burgess AR. Use and satisfaction with prosthetic devices among persons with trauma-related amputations: a long-term outcome study. Am J Phys Med Rehabil 2001;80(8):563-571 Thesleff A, Branemark R, Hakansson B, Ortiz-Catalan M. Biomechanical Characterisation of Bone-anchores Implant Systems for Amputation Lim Prostheses: A Systematic Review.Ann Biomed Eng 2018;46(3):377-391 [xiii] Frölke JPM. vd Meent H. Klikprothese (endo-exoprothese) voor patiënten met problematische amputatiestomp.Ned Tijdschr Geneeskd. 2010;154:A2010Medline. Cadth rapid response report: summary with critical appraisal. Osseointegrated prosthetic implants for lower limb amputation: a review of critical effectiveness, cost effectiveness and guidelines. 2017 Pezzin LE, Dillingham TR, MacKenzie EJ, Ephraim P, Rossbach P. Use and satisfaction with prosthetic limb devices and related services. Arch Phys Med Rehabil 2004;85:723-729 Sansam K, Neuman V, O’Connor R, Bhakta B. Predicting walking ability following lower limb amputation: a systamatic review of the literature.J Rehabil Med 2009;41:593-603 Meulenbelt HE, Geertzen JH, Jonkman MF, Dijkstra PU.Determinants of skin problems of the stump in lower-limb amputees. Arch Phys Med Rehabil 2009;90:74-81Medline. Desmond D, Gallagher P, Henderson-Slater D, Chatfield R. Pain and psychosocial adjustment to lower limb amputation amongst prosthesis users. Prosthet Orthot Int 2008;32:244-252. Desmond DM, MacLachlanM. Affective distress and amputation-related pain among older men with long-term, traumatic limb amputations.J Pain Symptom Manage 2006;31:362-368 Borsje S, Bosman JC, van der Schans CP, Geertsen JH, Dijkstra PU.Phantom pain: a sensitivity analysis. Disabil Rehabil 2004;26(14-15):905-910 Legro MW. Reiber G, del Aguila M, Ajax MJ, Boone DA, Larsen JA, Smoth DG, SangeorzanB. Issues of importance reported by persons with lower limb amputations and prosthesis. J Rehabil Res Dev 1999;36:155-163 Murray CD, Fox J. Body image and prosthesis satisfaction in the lower limb amputee. Disabil Rehabil 2002;24:925-931 Fisher K, Hanspal R. Body image and patients with amputations: does the prosthesis maintain the balance? Int J Rehabil Res 1998;21:355-363 Murray CD. The social meanings of prosthesis use.J Health Psychol 2005;10:425-441 Schaffalitzky E, Gallagher P, MacLachlan M, Wegener ST.Developing consensus on important factors associated with lower limb prosthetic prescription and use. Disabil Rehabil 2012;34(24):2085-2094 Schiff A, Havey R, Carandang G, Wickman A, Angelico J, Patwardhan A, Pinzur M. Quantification of shear streaa within a transtibial prosthetic socket. Foot Anckle Int 2014;35(8):779-782 Gholizadeh H, Abu Osman NA, Eshraghi A, Ali S. The effects of suction systems on transtibial amputees’ gait performance. PLoS One 2014;9(5).e94520 Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil 20013;25:1278-80 Donovan-Hall MK, Yardley L, Watts RJ. Engagement in activiteits revealing the body and psychosocial adjustment in adults with a trans-tibial prosthesis. Prosthet Orthot Int 2002;26:15-22 European Patent Office, Global Patent Index - EP 3593765 A1; [Geertzen JH, Rietman JS. Amputatie en prothesiologie van de onderste extremiteit.2e dr. Den Haag: Lemma; 2008. Authors Jeroen Groot; Medical Doctor at 'Reade revalidatie en reumatologie', Amsterdam Martijn Pas; Medical Doctor at Bravis Ziekenhuis Roosendaal Bergen op Zoom Bart de Kiefte; CTO at Livit Orthopedie, Dordrecht Marcella van der Ent; Technical Engineer at Livit Orthopedie Wouter de Vos; CPO and regional manager at Livit Orthopedie, Rotterdam Bas van den Brand; CPO and regional manager at Livit Orthopedie, Dordrecht Wouter Akkerman; Director Operational Management at Livit Orthopedie, Dordrecht Jan van de Werken; Technical advisor to management of Livit Orthopedie Jan Willem van der Windt; Research and Development at Livit Orthopedie, Amsterdam
control the pressure distribution in your socket wherever, whenever.
The pressure distribution of the 3DP socket can be adjusted with one “click” based on stump volume changes over the course of the day.
ADAPT-IT Adjust the pressure distribution of the 3D Printed socket for trans-tibial prosthesis with one “click” based on stump volume changes.
10 - ADAPT-IT
Quick on & off the ‘quick release’ button will make it easier than ever to take your prosthetic socket on and off,
Adaptive Volume
Say goodbye to extra stump socks
The pressure distribution of the 3DP socket can be adjusted with one “click” based on stump volume changes over the course of the day. Patented design, this unique functionality is the result of a: Multi-blade, propeller-shaped collection system, a flexible connection with the base system; and a smart, adjustable closure with a mechanical dial and strong steel wire that can be used to tighten, secure, and loosen the system. (BOA system) With the new ADAPT-IT volume adaptive socket by Livit Orthopedie, prosthesis wearers can control pressure distribution in their socket wherever, whenever. Unique features of the Volume Adaptive Socket: Adaptive Volume Lifelike feeling Control your clothes Say goodbye to extra stump socks Quick on & off Greater sitting comfort Extra compression in active scenarios
Control your clothes
Extra compression in active scenarios
Figure 1: ADAPT-IT drawing of the volume adaptive socket. The invention is further illustrated by the following 3 figures, which show the embodiment of the device and method.
zorgprofessionals@ livit.nl
zorgprofessionals.livit.nl
This book describes the results of a large-scale study into the effectiveness of orthopaedic devices. With this book, Livit Orthopedie wants to contribute to the promotion of transparency in orthopedic care and support physicians, specialists, and patients in creating the best care plan for the patient. We do this by sharing the out comes of our effectiveness studies in this book, across various (cust om-made) provisions. This book is available to download from zorgprofessionals.livit .nl, and hardcopies will be available in waiting rooms at Livit locations and a number of out patient clinics at hospitals, institutions, and rehabilitation centers.
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