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

Phase 3

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Other: Control; Device: Rebel Reliever

• Registration Number: NCT02021136
• Lead Sponsor: Thuasne

Brief 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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-29
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Male or female over 18 years
• BMI < or egal to 35kg/m2
• symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence)
• diagnosis of medial femoro-tibial knee osteoarthrosis
• patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection

Main

Exclusion Criteria

• femoro-patellar predominant arthrosis
• septic arthritis
• metabolic arthropathies
• chronical rheumatismal diseases
• other knee diseases
• symptomatic coxarthrosis
• controlateral gonathrosis with corticoids injections
• any other serious disease which may interfere with the results
• psychiatrics disorders
• skin lesions or dermal pathologies
• venous or arterial disorders
• sensitivity disorders in the lower limbs (diabetes mellitus..)
• paracetamol intolerance
• hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
• on going knee viscosupplementation at inclusion
• slow acting OA drugs (if started in the last 2 months prior to inclusion)
• opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
• pregnant women of with no contraception
• hepatic or renal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	usual antalgic treatment + physical exercises recommendations.
Rebel reliever	Rebel Reliever	Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations.

Primary Outcome Measures

Name	Time	Method
Evolution of the last 24 hours knee pain (VAS)	Between Day 49 and Day 0

Secondary Outcome Measures

Name	Time	Method
Evolution of knee pain on movement (VAS)	Between Day 49 and Day 0	Evaluation with Visual Analysis Scale
Evolution of Lequesne Algofunctional index score	Between D49 and Day 0
Responder rate according to OARSI-OMERACT criteria	At Day 49

Trial Locations

Locations (1)

Euraxi Pharma; 🇫🇷 Joue-les-tours, Bp 80325, France