Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 10
- 主要终点
- improvement in KOOS pain subscales
研究概览
简要总结
The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.
详细描述
Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are to be included in the study. Patients suffering from isolated, single and focal cartilage or osteochondral defect at the knee joint are considered for study inclusion.
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 55 Years（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
improvement in KOOS pain subscales
时间窗: 24 months
The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale
次要结局
- KOOS total score(24 months)