Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Signal to Noise Quotient
研究概览
简要总结
This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 80 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.
详细描述
This is a prospective randomized, controlled, single-center clinical trial study on ACL reconstruction surgery technique. In this study, 80 patients with ACL rupture were recruited according to the enrollment criteria. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. In this study, 40 patients with ACL rupture in the experimental group will be treated with all-inside reconstruction technique, and 40 patients with ACL rupture in the control group will be treated with complete tibial tunnel technique. All operations will be performed with 4-strand autologous semitendinosus tendon. All fixations will be performed using an adjustable cortical suspensory system. After reconstruction, all subjects will participate in the collection of clinical function scores including Marx Activity score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided informed written written consent;
- •Patients aged between 18 and 45;
- •Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
- •Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft
排除标准
- •Patients who have not signed informed consent;
- •Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
- •Revision procedures
- •Patients unable to lay still in an MRI or CT scanner
- •Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
- •Patients who had an excessive tibial slope >12 degrees
结局指标
主要结局
Signal to Noise Quotient
时间窗: 1 year
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
次要结局
- Marx Activity Rating Score(1 year)
- Side to side difference in anterior tibial translation(6 weeks, 3 months, 6 months, 9 months, 1 year)
- Difference in Computed Tomography (CT) imaging of Tunnels(1 day, 6 months, 1 year)
- International Knee Documentation Committee (IKDC)(1 year)