Osteoarthritis, Knee Clinical Trial
Official title:
Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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