NCT01025895Unknown4 期
Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test
研究概览
简要总结
ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •knee instability with a history of ACL tear
- •diagnosed ACL tear according to MRI
- •age range 16-40.
排除标准
- •previous surgery in the knees
- •multiple ligament raptures
- •partial ACL tear
- •severe cartilage degeneration
- •genovaruse/genovalgus
- •thin hamstrings tendons
- •oper epiphysis in the knee joint
- •patient with muscle/neurological problem that increases the tendency to fall
结局指标
主要结局
WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test
时间窗: pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.
次要结局
未报告次要终点
研究者
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