NCT03219307进行中（未招募）3 期
Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- KOOS pain subdomain score
研究概览
简要总结
This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.
详细描述
This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participated in study AAG-G-H-1220
- •identified as a microfracture failure patient
- •voluntary consent to participate in the study
排除标准
- •other cartilage repair procedures performed on target knee
- •other conditions that would interfere with healing or evaluating outcomes
- •lesions requiring implants larger than 9cm2
- •non-compliance with requirements in study AAG-G-H-1220
结局指标
主要结局
KOOS pain subdomain score
时间窗: 24 months
Comparison of pain scores from the KOOS questionnaire from baseline
次要结局
- IKDC subjective scores(24 months)
- KOOS function subdomain score(24 months)
- VAS pain scale(24 months)
研究者
研究点 (10)
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