Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 24
- 主要终点
- Clinical evaluation scoring system
研究概览
简要总结
Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.
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 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated femoral osteochondral lesion
- •aged 18 to 50
- •grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm
- •IKDC score below 55
排除标准
- •pregnancy
- •arthrosis
- •varus or valgus angle greater than 10°
- •ACL laxity
- •Severe chronic disease
- •BMI > 30 Kg/m2
- •HIV, B or C Hepatitis
结局指标
主要结局
Clinical evaluation scoring system
时间窗: IKDC
次要结局
- MRI(at 2 years)
- Arthroscopy with biopsy(at 2 years)
