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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00613-42 | Other Identifier | ANSM number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebel reliever | Experimental | Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations. |
|
| Control | Active Comparator | usual antalgic treatment + physical exercises recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebel Reliever | Device | Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the last 24 hours knee pain (VAS) | Between Day 49 and Day 0 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with at least one adverse event or serious adverse event in each groups. | during the 6 weeks of brace wearing |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe THOUMIE, MD | Coordinator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Euraxi Pharma | Joué-lès-Tours | Bp 80325 | 37303 | France |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Control | Other | Usual antalgic treatment + physical exercises recommendations |
|
| Responder rate according to OARSI-OMERACT criteria | At Day 49 |
| D012216 |
| Rheumatic Diseases |