Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR Plug) for Repair of Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- RTI Surgical
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- MRI to Evaluate Success of Outcome.
研究概览
简要总结
The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.
详细描述
The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).
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
- •Are male or female at least 18 years of age and up to 55 years of age
- •Must be skeletally mature
- •Have a grade III or IV lesion in femoral condyle
排除标准
- •Skeletally immature
- •Osteoarthritic knees, osteonecrotic knees, osteophyte formation
- •Use of any investigational therapy within thirty (30) days prior to the first visit
结局指标
主要结局
MRI to Evaluate Success of Outcome.
时间窗: 24 months
The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively. The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.
次要结局
未报告次要终点