NCT01148784已完成不适用
A Prospective Randomized Comparison of Doubled Versus Quadrupled Allogenic Tissue Constructs for Anterior Cruciate Ligament Reconstruction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Knee outcome scores
研究概览
简要总结
The purpose of this study is to compare two different soft tissue allografts, double bundle tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn anterior cruciate ligament (ACL) of 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACL injury is the primary limitation to activities of daily living.
排除标准
- •Multiple current ligamentous injuries to the knee.
- •Revision reconstruction of the ACL.
- •Uncorrected instability of the ACL on the opposite knee.
研究组 & 干预措施
Quadrupled Hamstring Allograft
Active Comparator
干预措施: ACL reconstruction (Procedure)
Doubled Tibialis Anterior Allograft
Active Comparator
干预措施: ACL reconstruction (Procedure)
结局指标
主要结局
Knee outcome scores
时间窗: One year
The change of physical function and pain as evaluated by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score).
次要结局
未报告次要终点
研究者
Dennis Crawford
Principal Investigator
Oregon Health and Science University
研究点 (2)
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