Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 118
Inclusion Criteria
- patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection
- BMI < or egal to 35kg/m2
- 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
- BMI < or egal to 35kg/m2
- diagnosis of medial femoro-tibial knee osteoarthrosis
- 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)
- Male or female over 18 years
Exclusion Criteria
- pregnant women of with no contraception
- metabolic arthropathies
- septic arthritis
- ...
- pregnant women of with no contraception
- metabolic arthropathies
- septic arthritis
- any other serious disease which may interfere with the results
- venous or arterial disorders
- symptomatic coxarthrosis
- paracetamol intolerance
- femoro-patellar predominant arthrosis
- on going knee viscosupplementation at inclusion
- opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
- other knee diseases
- psychiatrics disorders
- hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
- chronical rheumatismal diseases
- controlateral gonathrosis with corticoids injections
- slow acting OA drugs (if started in the last 2 months prior to inclusion)
- hepatic or renal insufficiency
- skin lesions or dermal pathologies
- sensitivity disorders in the lower limbs (diabetes mellitus..)
Summary
- Conditions
- Osteoarthritis (Knee)
- Osteoarthritis, Knee
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 pa...
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.
Inclusion Criteria
- patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection
- BMI < or egal to 35kg/m2
- 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
- BMI < or egal to 35kg/m2
- diagnosis of medial femoro-tibial knee osteoarthrosis
- 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)
- Male or female over 18 years
Exclusion Criteria
- pregnant women of with no contraception
- metabolic arthropathies
- septic arthritis
- ...
- pregnant women of with no contraception
- metabolic arthropathies
- septic arthritis
- any other serious disease which may interfere with the results
- venous or arterial disorders
- symptomatic coxarthrosis
- paracetamol intolerance
- femoro-patellar predominant arthrosis
- on going knee viscosupplementation at inclusion
- opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
- other knee diseases
- psychiatrics disorders
- hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
- chronical rheumatismal diseases
- controlateral gonathrosis with corticoids injections
- slow acting OA drugs (if started in the last 2 months prior to inclusion)
- hepatic or renal insufficiency
- skin lesions or dermal pathologies
- sensitivity disorders in the lower limbs (diabetes mellitus..)
Tracking Information
- NCT #
- NCT02021136
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Philippe THOUMIE, MD Coordinator
- Philippe THOUMIE, MD Coordinator
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