Pivotal Study in Europe for CE Mark
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 7
- 主要终点
- Defect fill at 6 months determined by magnetic resonance imaging (MRI)
研究概览
简要总结
The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.
详细描述
Current treatment approaches for articular cartilage defects have been disappointing and clinical results have been variable. However, when using crosslinked hydrogel technologies, in vitro findings have shown chondrocyte growth and extra-cellular matrix (ECM) production supportive of cartilage production.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A standing radiograph of the knee showing a Kellgren score of 0-2
- •Body mass index ≤33
- •An Outerbridge score of III or IV without need for bone graft
- •A meniscus with no more than partial resection in the affected knee
排除标准
- •Passive motion deficit of the knee (>5º of extension, >15º of flexion)
- •Moderate or severe osteoarthritis
- •Diabetes mellitus (IDDM Type 1)
- •Patellofemoral instability
- •Malalignment with > 5° valgus or varus compared to contralateral knee
- •Active osteomyelitis
研究组 & 干预措施
ChonDux plus microfracture
干预措施: ChonDux (Device)
Microfracture
干预措施: ChonDux (Device)
结局指标
主要结局
Defect fill at 6 months determined by magnetic resonance imaging (MRI)
时间窗: 6 months
次要结局
- Knee function as assessed by the IKDC questionnaire(6 months)
- Pain score (VAS)(6 months)
- SF-36 Health Survey(6 months)