NCT02765685已完成不适用
Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA Made-to-measure Hinged Knee Brace Versus Usual Care.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Pain measured using a VAS (visual analogue scale) by the patient
研究概览
简要总结
This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups:
- 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months.
- 60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down.
The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Knee osteoarthritis (defined according to American College of Reumatology criteria):
- •radiological stage II, III or IV according to the Kellgren and Lawrence (KL) classification documented by a radiological examination in the previous 12 months.
- •Predominantly affecting the internal compartment (internal KL stage greater than external KL stage) and symptomatic with a Pain Visual Analogue Scale > 40/100 on the target side (side with the most symptomatic disease)
- •Patients who have provided written consent
- •Patients able to understand simple instructions, to read, write, and to give informed consent
- •Patients with national health insurance cover
排除标准
- •Severe venous insufficiency in the lower limbs
- •History of deep venous thrombosis in the lower limbs
- •Inflammatory flare of knee osteoarthritis (synovial effusion) on the target side
- •Person over 18 under guardianship or unable to provide consent
- •Pregnant or breast-feeding women
结局指标
主要结局
Pain measured using a VAS (visual analogue scale) by the patient
时间窗: 12 months
次要结局
- Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire(12 months)
- Evolution de overall disease activity measured by VAS(12 months)
- Ratio differential cost-utility(12 months)
- Evolution of pain measured by VAS in the form of a self-questionnaire(6 months)
- Evolution of quality of life measured by the AMIQUAL self-questionnaire(12 months)
- Consumption of care relative to the knee osteoarthritis(12 months)
- Local or general adverse effects(12 months)
- Compliance with wearing the brace(12 months)
研究者
研究点 (2)
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