NCT02345564Unknown不适用
Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery
Barmherzige Brüder Eisenstadt0 个研究点目标入组 15 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 主要终点
- MRI imaging - gap between cartilage-implant surface in mm
研究概览
简要总结
Osteochondral lesions in knee and ankle are injuries commonly seen in young patients. MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects.
This prospective study follows patients treated with MaioRegen implants from pre-surgery until 24 months post-surgery.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single osteochondral lesion in knee/ankle (2-4 sq cm)
排除标准
- •multiple osteochondral lesions
- •pre-existing injuries/arthropathies
结局指标
主要结局
MRI imaging - gap between cartilage-implant surface in mm
时间窗: 18 months post surgery
ingrowth of fleece into the cartilage
次要结局
- clinical outcome measurement(24 months post-surgery)
研究者
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