Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.

Detailed Description
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The main criteria is the evaluation of global knee pain during the last 24 hours at D 49 after the inclusion. The response to the treatment will be evaluated during the inclusion visit (V1/D0) and after 6 weeks of treatment, during the following visit (V3/D49). The level of the global pain of the patient during the last 24 hours will be collected by investigators with a VAS (0 mm = no pain ; 100mm = maximun pain) at each visit.

Official Title
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Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Rebel Reliever
* Other: Control


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male or female over 18 years BMI < or egal to 35kg/m2 symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence) diagnosis of medial femoro-tibial knee osteoarthrosis patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection Main Exclusion Criteria: femoro-patellar predominant arthrosis septic arthritis metabolic arthropathies chronical rheumatismal diseases other knee diseases symptomatic coxarthrosis controlateral gonathrosis with corticoids injections any other serious disease which may interfere with the results psychiatrics disorders skin lesions or dermal pathologies venous or arterial disorders sensitivity disorders in the lower limbs (diabetes mellitus..) paracetamol intolerance hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion on going knee viscosupplementation at inclusion slow acting OA drugs (if started in the last 2 months prior to inclusion) opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion pregnant women of with no contraception hepatic or renal insufficiency

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebel reliever<br>Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations. | Device: Rebel Reliever<br>* Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations<br>|
| Active Comparator: Control<br>usual antalgic treatment + physical exercises recommendations. | Other: Control<br>* Usual antalgic treatment + physical exercises recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the last 24 hours knee pain (VAS) |  | Between Day 49 and Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of knee pain on movement (VAS) | Evaluation with Visual Analysis Scale | Between Day 49 and Day 0 | 
| Evolution of Lequesne Algofunctional index score |  | Between D49 and Day 0 | 
| Responder rate according to OARSI-OMERACT criteria |  | At Day 49 |