NCT01477008已完成不适用
A Prospective, Multi-Center, Randomized Clinical Trial Comparing the Biphasic Cartilage Repair Implant to Marrow Stimulation in the Treatment of Focal Chondral and Osteochondral Lesions of the Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 11
- 主要终点
- IKDC-2000 Subjective Knee Evaluation
研究概览
简要总结
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial femoral condyle, lateral femoral condyle, or trochlea of the knee. The hypothesis is that the BiCRI provides an improvement in pain and function as compared to baseline, that is no worse than marrow stimulation at 1 year.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
IKDC-2000 Subjective Knee Evaluation
时间窗: 12 months
Subjective evaluation of knee pain and function (will be captured at preop and each postop visit through 12 months)
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Preop, 6 weeks, 3 months, 6 months, and 12 months)
- Arthroscopy with biopsy(12 months)
- IKDC-2000 Knee Examination Form(Preop, 6 weeks, 3 months, 6 months, and 12 months)
- IKDC-2000 Current Health Assessment Form(Preop, 6 weeks, 3 months, 6 months, and 12 months)
- Adverse Events(Treatment through 12 months)
- Radiographs(Preop, immediate postop, 6 weeks, 3 months, 6 months, 12 months)
- Magnetic Resonance Imagining (MRI)(Preop and 12 months)
- Pain (VAS): sitting, standing, and squatting(Preop, 6 weeks, 3 months, 6 months, and 12 months)
研究者
研究点 (11)
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