Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis (ROTOR)
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|ClinicalTrials.gov Identifier: NCT02021136|
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: Rebel Reliever Other: Control||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Rebel reliever
Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations.
Device: Rebel Reliever
Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations
Active Comparator: Control
usual antalgic treatment + physical exercises recommendations.
Usual antalgic treatment + physical exercises recommendations
- Evolution of the last 24 hours knee pain (VAS) [ Time Frame: Between Day 49 and Day 0 ]
- Evolution of knee pain on movement (VAS) [ Time Frame: Between Day 49 and Day 0 ]Evaluation with Visual Analysis Scale
- Evolution of Lequesne Algofunctional index score [ Time Frame: Between D49 and Day 0 ]
- Responder rate according to OARSI-OMERACT criteria [ Time Frame: At Day 49 ]
- Percentage of patients with at least one adverse event or serious adverse event in each groups. [ Time Frame: during the 6 weeks of brace wearing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021136
|Joue-les-tours, Bp 80325, France, 37303|
|Principal Investigator:||Philippe THOUMIE, MD||Coordinator|