NCT02021136

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Thuasne · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Rebel Reliever	Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations
OTHER	Control	Usual antalgic treatment + physical exercises recommendations

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2013-12-27
• Last updated: 2016-12-30

Locations

1 site across 1 country: France