Anterior Cruciate Ligament Reconstruction (ACLR) Using Direct Insertion Technique or Traditional Technique With Single and Double Bundle Procedure.
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 主要终点
- Tegner score of the knee
研究概览
简要总结
The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.
详细描述
The investigators divide 320 patients with ACL rupture into 4 groups, each group has 80 patients. The operation technique is different among the groups: group A: conventional anatomical double bundle acl reconstruction, group B: conventional anatomical single bundle acl reconstruction, group DA: direct insertion double bundle acl reconstruction, group DSB: direct insertion single bundle acl reconstruction. The investigators compare the results of the patients of each group at 2 years of surgery.
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
- Double (Investigator, Outcomes Assessor)
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
- •ACL rupture patients aged between 16 to 40 years
排除标准
- •combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation)
- •any injury or surgery to the contralateral knee
- •any infammatory or systemic disease, neuromuscular disease in the lower limbs, any recent knee infection
结局指标
主要结局
Tegner score of the knee
时间窗: two years
Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
Lysholm score of the knee
时间窗: two years
Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
IKDC score of the knee
时间窗: two years
IKDC score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
次要结局
- KT-2000 of the knee(two years)
研究者
Jia-kuo yu
Professor
Peking University Third Hospital