Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain-free walking distance
研究概览
简要总结
The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.
详细描述
Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA.
A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use.
The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery.
The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.
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
- •Age ≥ 18 years
- •Medial femorotibial knee osteoarthritis grade 2, 3 or 4 according to the Kellgren Lawrence system
- •Visual Analog Scale pain ≥ 40/100 in the last 48 hours
- •Signed informed consent prior to any study-mandated procedure.
- •Affiliated to the General regime of the Social Security or covered by a similar health insurance system
排除标准
- •Inability to walk or dependance on a wheelchair or use of crutches.
- •Diseases that do not allow participation in the study for a period of six weeks.
- •Concomitant ipsilateral patellofemoral osteoarthritis associated with a more severe pain than the one for medial OA.
- •Ipsilateral osteoarthritis of the hip associated with a more severe pain than the one for medial OA.
- •A body mass index over
- •Successful Cortisone injection within the last four weeks before the start of the study.
- •Participation to any other clinical study which has an impact on the different endpoints.
- •Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
- •Inability to communicate in German.
结局指标
主要结局
Pain-free walking distance
时间窗: 6 weeks
The evolution of pain-free walking distance evaluated by reporting the distance that the patient can walk without pain.
次要结局
- Knee functional capacity(6 weeks)
- Assessment of compliance(6 weeks)
- Pain on loading(6 weeks)
- Pain at rest(6 weeks)
- Subjective range of movement(6 weeks)
- Analgesic consumption(6 weeks)
- Objective range of movement(6 weeks)
- Assessment of safety (AE and SAEs)(6 weeks)
- Assessment of Patient's Global Impression of Change (PGI-C)(6 weeks)
- Assessment of patient's satisfaction(6 weeks)