NCT01066702终止3 期
A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
Histogenics Corporation59 个研究点 分布在 2 个国家目标入组 245 人开始时间: 2010年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 245
- 试验地点
- 59
- 主要终点
- The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score)
研究概览
简要总结
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •greater than 18 years old
- •symptomatic articular cartilage lesion of the femur and/or trochlea
排除标准
- •prior surgical intervention other than debridement
- •arthritis
- •clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
研究组 & 干预措施
NeoCart
Experimental
Autologous cartilagenous tissue implant
干预措施: NeoCart (Biological)
Microfracture
Active Comparator
surgical intervention
干预措施: Microfracture (Procedure)
结局指标
主要结局
The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score)
时间窗: one year
次要结局
- Repair cartilage structure as measured by magnetic resonance imaging (MRI)(one year)
研究者
研究点 (59)
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