Clinical trial NCT02021136: Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evolution of the last 24 hours knee pain (VAS)
timeFrame: Between Day 49 and Day 0
Secondary outcomes:
measure: Evolution of knee pain on movement (VAS)
timeFrame: Between Day 49 and Day 0
measure: Evolution of Lequesne Algofunctional index score
timeFrame: Between D49 and Day 0
measure: Responder rate according to OARSI-OMERACT criteria
timeFrame: At Day 49
Other outcomes:
measure: Percentage of patients with at least one adverse event or serious adverse event in each groups.
timeFrame: during the 6 weeks of brace wearing
Locations:
city: Joue-les-tours
country: France
facility: Euraxi Pharma
state: Bp 80325
Study officials:
affiliation: Coordinator
name: Philippe THOUMIE, MD
role: PRINCIPAL_INVESTIGATOR
References: