Comparison of the Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques: Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Isokinetic testing
研究概览
简要总结
Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last 20 years. However, data in the literature reveal that approximately 15-25% of patients undergoing surgery still do not present optimal outcomes, which suggests that there is room for improvement of the procedure. A possible explanation for this fact is that most ACL reconstructions consider only one of the functional bundles of the ligament. Our hypothesis is that the ACL reconstruction with the double-bundle technique will be effective in reducing the patients' rotation of the knee joint for high-demanding tasks compared to the patients who had ACL reconstruction with the single-bundle technique.
详细描述
The aim of this study is to compare the ACL reconstruction with only one bundle (one tunnel in the tibia and femur) with the procedure to reconstruct the the ACL with two bundles with 2 tunnels in the tibia and 2 in the femur (considered closest to the normal anatomy of of the ACL), both in terms of objective and subjective results.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •Body mass index (BMI), which corresponds to the ratio between weight in kilograms (pounds) and height in m2 (square meters) between 18.5 and 24.
- •Anterior instability alone or associated with chondral lesions of up to 1cm or associated with meniscal injuries that do not alter the postoperative rehabilitation.
- •Magnetic resonance imaging (MRI) confirming the ACL injury.
- •Aged between 20 and 45 years.
- •Not having asymmetric varus alignment, greater than or equal to 5 degrees (to eliminate cases with indication for osteotomy of the tibia), using panoramic radiographic comparison of the lower limbs in standing position.
- •Absence of associated ligament instabilities (medial, lateral or posterior).
- •No previous surgery on the affected knee.
排除标准
- •New post-surgical trauma after 12 months.
- •Interruption of treatment / follow-up.
- •Postoperative infection.
结局指标
主要结局
Isokinetic testing
时间窗: 2 years
Tests the muscle power and endurance
Subjective and Objective IKDC Scores
时间窗: 2 years
The subject will answer the subjective IKDC score and the investigator will complete the objective IKDC score
Kinematic evaluation
时间窗: 2 years
The subjects will perform 3 tasks. Walking with no change of direction. Walking with change of direction: walk straight until one foot will touch the force platform and at that moment the subject must change their direction of motion and make a 90° angle with respect to the original trajectory by rotating the body to the side of the foot that will touch the platform. Landing with change of direction: step down 4 steps of a stair as they touch the force platform in the ground, they change the direction of their motion so that the new trajectory will make a 90° angle with the former direction.
次要结局
未报告次要终点