Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pain score on visual analogic scale
研究概览
简要总结
The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient understanding simple order and able to give written consent.
- •Man or woman with age between 40 et 75 years
- •Unilateral medial symptomatic knee osteoarthritis, defined using the American College of Rheumatology classification
- •Radiologic grade II, III ou IV (Kellgren et Lawrence (KL) classification)
- •Medial knee compartment (Medial K&L g rade higher than lateral K&L grade
- •Knee pain > 40/100 on visual analog scale and <30/100 for the other
- •No change in medical treatment for at least 3 months.
- •Latest radiographic image < 12 months before inclusion
排除标准
- •Patient without healthcare insurance.
- •Inflammatory knee arthritis,
- •Indication of knee surgery
- •Pregnancy, breastfeeding
- •Associate neurologic or orthopaedic affection that interferes with gait analysis
- •Rapidly destructive arthritis.
- •Alzheimer's disease, Parkinson's disease, motor neuronal disorders
- •Patient under guardianship or tutelage
研究组 & 干预措施
Internal unicompartmental knee brace
干预措施: PROTEOR Internal unicompartmental knee brace (Device)
结局指标
主要结局
Pain score on visual analogic scale
时间窗: Baseline + 5 weeks
Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.
Pain score on visual analogic scale
时间窗: Baseline
Pain was self-evaluated by patient on visual analogic scale (VAS: 0-100, 0 = no pain at all; 100 = worst pain appendix 1). Such pain is widely used and validated in the literature for the evaluation of knee osteoarthritis treatment outcome.
次要结局
- Evaluation of the functional capacities: KOOS questionnaire.(baseline + 5 weeks)
- Evaluation of the functional capacities: KOOS questionnaire.(baseline)