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

THUASNE

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis, Knee

Treatments: Device: Rebel Reliever; Other: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT02021136

2013-A00613-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Rebel reliever

Experimental group

Description:

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

Treatment:

Device: Rebel Reliever

Control

Active Comparator group

Description:

usual antalgic treatment + physical exercises recommendations.

Treatment:

Other: Control