NCT02021136已完成3 期
Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Evolution of the last 24 hours knee pain (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evolution of the last 24 hours knee pain (VAS)
时间窗: Between Day 49 and Day 0
次要结局
- Evolution of knee pain on movement (VAS)(Between Day 49 and Day 0)
- Evolution of Lequesne Algofunctional index score(Between D49 and Day 0)
- Responder rate according to OARSI-OMERACT criteria(At Day 49)
研究者
研究点 (2)
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