Euraxi Pharma
Joué-lès-Tours, Bp 80325, 37303, France
NCT Number: NCT02021136
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Joué-lès-Tours, Bp 80325, 37303, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
Main Exclusion Criteria:
Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations
Usual antalgic treatment + physical exercises recommendations
Time frame: Between Day 49 and Day 0
Time frame: Between Day 49 and Day 0
Evaluation with Visual Analysis Scale
Time frame: Between D49 and Day 0
Time frame: At Day 49
Time frame: during the 6 weeks of brace wearing
Thuasne
Industry
Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.
Acronym: ROTOR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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