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

NCT ID: NCT02021136

Last Updated: 2016-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rebel reliever

Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations.

Group Type: EXPERIMENTAL

Rebel Reliever

Intervention Type: DEVICE

Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations

Control

usual antalgic treatment + physical exercises recommendations.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Usual antalgic treatment + physical exercises recommendations

Interventions

Rebel Reliever

Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations

Intervention Type: DEVICE

Control

Usual antalgic treatment + physical exercises recommendations

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thuasne

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe THOUMIE, MD

Role: PRINCIPAL_INVESTIGATOR

Coordinator

Locations

Euraxi Pharma

Joué-lès-Tours, Bp 80325, France

Countries

France

Other Identifiers

2013-A00613-42

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A00613-42

Identifier Type: -

Identifier Source: org_study_id