Internal Compartment Knee Osteoarthritis: ODRA (Orthosis Distraction and Rotation for osteoArthritis) Made-to-measure Hinged Knee Brace Versus Usual Care.

Study Overview
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Brief Summary
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This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups: 60 patients in the usual care group: these patients will receive the usual care proposed by their doctor for 12 months. 60 patients in the ODRA group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down. The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.

Official Title
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Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA Made-to-measure Hinged Knee Brace Versus Usual Care.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: brace ODRA (PROTEOR company)
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Knee osteoarthritis (defined according to American College of Reumatology criteria): radiological stage II, III or IV according to the Kellgren and Lawrence (KL) classification documented by a radiological examination in the previous 12 months. Predominantly affecting the internal compartment (internal KL stage greater than external KL stage) and symptomatic with a Pain Visual Analogue Scale > 40/100 on the target side (side with the most symptomatic disease) Patients who have provided written consent Patients able to understand simple instructions, to read, write, and to give informed consent Patients with national health insurance cover Exclusion Criteria: Severe venous insufficiency in the lower limbs History of deep venous thrombosis in the lower limbs Inflammatory flare of knee osteoarthritis (synovial effusion) on the target side Person over 18 under guardianship or unable to provide consent Pregnant or breast-feeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODRA<br> | Device: brace ODRA (PROTEOR company)<br>* Port of the orthosis ODRA during day during 12 months, Complement to their usual care. The subjects will have for instruction to wear the brace a minimum of 6 hours a day, 5 days a week, And to remove it during the rest periods in lengthened position.<br>Other: Usual care<br>* The patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the usual said coverage can be at the same time medicinal (anti-inflammatory, painkilling, …), non-medicinal (physiotherapy, port of an orthosis, …), even surgical, according to the influencers.<br>|
| Active Comparator: usual care<br> | Other: Usual care<br>* The patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the usual said coverage can be at the same time medicinal (anti-inflammatory, painkilling, …), non-medicinal (physiotherapy, port of an orthosis, …), even surgical, according to the influencers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured using a VAS (visual analogue scale) by the patient |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio differential cost-utility |  | 12 months | 
| Evolution of pain measured by VAS in the form of a self-questionnaire |  | 6 months | 
| Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire |  | 12 months | 
| Evolution of quality of life measured by the AMIQUAL self-questionnaire |  | 12 months | 
| Evolution de overall disease activity measured by VAS |  | 12 months | 
| Consumption of care relative to the knee osteoarthritis | Surgical operation, injectable medicinal treatments and anti-osteoarthritic of slow action, care of Support | 12 months | 
| Local or general adverse effects |  | 12 months | 
| Compliance with wearing the brace | Average number of hours of port of the brace a day, the average number of days of port of the brace a week. The possible motives for non-observance will be brought together. The patient will be considered compliant if he carries his brace at least 15 hours a week on average. | 12 months |