Validating the Clinical Effect of a Knee Orthosis
Phase: NA
Conditions: Medial Gonarthrosis
Sponsor: TOPMED

 
 
 
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Protocol for validating the clinical effect of a knee brace  
 
 
 
 
 
 
 
 
Presented to the Véritas IRB Research Ethics Committee 
 
 
 
 
 
TOPMED  
 
 Version 02 
Approved in French on May 8th 2024 
Translated on August 6th 2025 
NCT06655558 
 
 

 
 
 
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SCHEDULED START AND END DATES 
December 2023 to December 2024 
 
RESEARCH PROJECT DESCRIPTION 
Issues 
Knee orthoses are one form of treatment for patients suffering from gonarthrosis. The aim of this 
form of treatment is to compensate for certain biomechanical deficits in patients. A multitude of joint 
arrangements are available to target specific biomechanical deficits. A constant challenge for orthosis 
manufacturers is to transmit the biomechanical effect of the orthosis to the patient. The desired effect 
requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit the 
forces to the patient's bones due to its external nature. Orthotic customization is essential to improve 
the transmission and tolerance of the biomechanical effect. O3D Inc. is keen to validate the 
effectiveness of its new custom orthosis in treating symptoms. 
State of knowledge and project relevance  
The changing demographics of the Canadian population are playing an important role in the growing 
need for orthopaedic devices. The aging population is constantly on the rise, partly due to increasing 
life expectancy [1-3]. At the same time, chronic diseases of the musculoskeletal system (e.g. 
osteoarthritis), whose prevalence increases with age, are limiting the daily activities of sufferers, 
affecting more and more people [4]. Osteoarthritis is the most common form of these diseases 
worldwide [5]. According to the Institut de la statistique du Québec, nearly one in two Quebecers 
aged 15 and over suffers from a chronic health problem [6-8]. Furthermore, Statistics Canada informs 
us that “in 2016, 20.6% of Canadians aged 15 and over reported having been diagnosed with arthritis 
by a health professional" [9]. The knee is one of the critical joints in the practice of activities of daily 
living (ADLs). Knee orthoses are way of helping people with gonarthrosis to carry out their daily 
activities. 
The effectiveness of orthotic treatment can be measured by a reduction in gonarthrosis symptoms or 
medication intake, and potentially an increase in the patient's ability to perform problematic 
movements. As the orthoses will be custom-made, we wish to explore the relationship between 
orthotic efficacy and patient anthropometry. The Western Ontario and McMaster Universities 
Osteoarthritis Index Questionnaire (WOMAC) is a scientifically validated tool for measuring pain, 
stiffness and ability to perform tasks of daily living in gonarthrosis. This tool is used regularly with 
this type of patient to measure the evolution of their symptoms during various types of intervention. 
Research objectives 
The aim of this research is to validate the clinical effect of a custom-made orthosis.  
With this research, we seek to answer the following questions: 
- 
Does this new orthosis help control the symptoms of gonarthrosis? 
- 
Does the participants' anthropometry influence the control of gonarthrosis symptoms? 
Our hypotheses are that treatment with the new orthosis will reduce patients' symptoms. We have 
no hypotheses regarding a potential relationship between anthropometry and treatment efficacy. 
Financing 

 
 
 
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The project was funded by NSERC's Strengthening College and Community Innovation program in 
partnership with O3D Inc. 
Partner company 
O3D Inc. 
Éric Moreau, President 
303-5425 rue de Bordeaux, Montréal (Québec) H2H 2P9 
(514) 839-1361 
emoreau@o3d.io 
RESEARCH METHODOLOGY 
Research location 
On TOPMED's premises at Collège Mérici, 755 Grande-Allée Ouest, Quebec City.  
Type of test 
Measurements will be taken using a single-group repeated measures methodology: before and after 
an 8-week intervention. 
Measurement, assessment and data collection tools  
Questionnaires : 
A questionnaire containing general information: age, gender, height, weight and brace-wearing 
history. This questionnaire will only be completed prior to the start of treatment. 
A Quebec version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 
questionnaire will be used to quantify the evolution of the participant's symptoms and their effects 
on quality of life. This questionnaire will be completed twice (before and after the treatment phase). 
Anthropometric measurements : 
The anthropometric measurements used by O3D to make the participant's orthosis will be 
transmitted to the research team. These data will be used in analyses to explore relationships with 
treatment efficacy. 
Estimated duration of participants' activities 
Questionnaire 
Two questionnaires must be completed before starting treatment with the custom-made orthosis 
(total duration approx. 18 minutes). Participants who have already begun treatment will no 
longer be eligible for the study. After 8 weeks of treatment, a questionnaire will have to be 
completed again (duration approx. 15 minutes). For each questionnaire, a link will be sent to the 
participant by e-mail so that he or she can access it on the Lime Survey platform (accessible on the 
Internet). 
INVOLVEMENT OF LIVE HUMAN, ANIMAL OR MATERIAL PARTICIPANTS  
50 adult participants will be recruited. Participants must have gonarthrosis. Only participants who 
receive a regular model of the O3D orthosis will be able to take part. 

 
 
 
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Participant inclusion criteria:   
- 
Medial gonarthrosis; 
- 
Be between the ages of 18 and 75 inclusively; 
- 
Receive a regular model of the O3D orthosis 
Participant exclusion criteria:   
- 
Tri-compartmental gonarthrosis 
- 
Have completed the delivery meeting for your O3D orthosis 
SCIENTIFIC JUSTIFICATION FOR USING LIVE SUBJECTS 
The participation of human participants representative of the clientele is essential for validating the 
efficacy of treatment with the custom-made orthosis. The evolution of the participants' symptoms 
will give us essential information on the efficacy of the orthosis, and relationships can be explored 
between it and their anthropometric measurements. 
RECRUITMENT 
Potential candidates will receive information about the research project and a link to the study page 
on our website when they visit us for impressions to make a regular model of an O3D orthosis. 
Candidates must register their interest via our website. The information and consent form will be 
sent to the e-mail address provided. The research team will be available to answer any questions 
candidates may have (etudes@topmed.ca), assess eligibility, send documentation and/or set up a 
telephone appointment at a later date. 
RISKS AND DRAWBACKS, AND PROPOSED MITIGATION MEASURES  
An allergic skin reaction (redness) due to wearing the brace is a potential injury. The participant 
should stop wearing the brace, if necessary. 
Bruises, corns, scratches and/or pain may appear on the braced limb, due to improper fitting of the 
brace or incorrect positioning of the brace. Injuries due to brace breakage are also possible. 
ADVANTAGES AND BENEFITS  
No immediate benefit for participants, except the benefit of trying a new orthosis that could improve 
their quality of life. The advantage of their participation is that it will provide empirical data on 
orthosis wear. This is an advantage for O3D Inc. 
FREE AND INFORMED CONSENT  
The Lime Survey link containing the Information and Consent Form (ICF) will be e-mailed to them 
once they have shown interest. A delay of one (1) week will be allowed for reading and reflection. In 
order to participate in the study, participants must have completed the first questionnaire before the 
orthosis delivery date.  
Participants may terminate their participation at any time without negative consequences or 
prejudice and without having to justify their decision. In this case, participants must inform the 
responsible researcher or a member of the research team. Thereafter, all material allowing the 
identification of the participant and the data provided will be destroyed, unless the participant 
authorizes the researcher to use them for research purposes despite the withdrawal. In this case, the 
information will be retained as described below and will be applied to all other participants. 

 
 
 
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CONFIDENTIALITY AND PROTECTION OF PERSONAL INFORMATION 
The information collected in the questionnaires and anthropometric measurements is confidential 
and will be used only for the purposes of this research project, unless otherwise agreed by the 
participant. All data collected, notes and computer records are encrypted on servers. Unless required 
by law, no information that could directly or indirectly reveal your identity will be disseminated or 
published without your prior explicit consent. 
All digital questionnaires have been created using the Lime Survey platform. The processed 
information is hosted in Canada on the platform's encrypted servers (Secure Socket Layer 
procedure), which comply with the RGPD standard. 
Data will be stored in coded form for a period of five (5) years, then anonymized in a database for 
retention for a period of ten (10) years for statistical reference purposes. 
CONTINUOUS EXAMINATION 
Should any inconvenience arise during or as a result of the research project, participants will be 
promptly notified. 
DISSEMINATING RESULTS 
No disclosure to patients will be made following the trials. 
A scientific publication of the results is planned. 
COMPENSATION 
No compensation will be offered for participation in this study. 
RESPONSIBILITY 
The legal rights of each participant will be maintained. 
PROTOCOL SEQUENCE  
First contact 
Demonstration of the participant's interest by answering via the TOPMED website's 
research page. 
Admission 
Sending documents and explanations : 
▪ 
0241_O3DA_CourrielFIC (contains link to FIC and online questionnaire) 
▪ 
0241_O3DA_CourrielQuest (contains link to online questionnaire) 
Receipt of signed consent and questionnaire 
Receiving anthropometric measurements 
8-week lead time 
Final questionnaire sent 
Data processing 
Data recording: Questionnaires and anthropometric measurements