Study of Single And Double Bundle ACL Graft Cross-sectional Dimensions Compared With Native ACL
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- long axis of the cross-sectional area of the reconstructed ACL
研究概览
简要总结
To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.
详细描述
The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.
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
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACL rupture patients aged between 10 to 50 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 inflammatory or systemic disease, neuromuscular disease in the lower limbs,any recent knee infection
结局指标
主要结局
long axis of the cross-sectional area of the reconstructed ACL
时间窗: 3-6 weeks
long to short axis ratio of the cross-sectional area of the reconstructed ACL
时间窗: 3-6 weeks
short axis of the cross-sectional area of the reconstructed ACL
时间窗: 3-6 weeks
cross-sectional area of the reconstructed ACL
时间窗: 3-6 weeks
次要结局
未报告次要终点
研究者
Jia-kuo yu
Professor
Peking University Third Hospital