Clinical Comparison and Motion Analysis of Sports Function Between Combined Anterolateral Ligament Reconstruction With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Functional performance and return to sport
研究概览
简要总结
The goal of this clinical trial is to test and compare different surgical techniques in patients with anterior cruciate ligament (ACL) injuries. The main questions it aims to answer are:
- What are the optimal criteria for selecting between single-bundle ACL reconstruction combined with anterolateral ligament (ALL) reconstruction versus double-bundle ACL reconstruction combined with ALL reconstruction?
- How do these two surgical techniques compare in terms of post-operative knee stability, functional outcomes, and reducing re-tear rates?
Participants will:
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Undergo pre-operative MRI imaging, ligament stability testing, and motion analysis evaluations
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Be randomly assigned to either:
-
Single-bundle ACL + ALL reconstruction
-
Double-bundle ACL + ALL reconstruction
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Receive the assigned surgical procedure
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Participate in post-operative follow-ups, ligament stability testing, and motion analysis at 6 months and 1 year
Researchers will compare the single-bundle ACL + ALL group and the double-bundle ACL + ALL group to see if one technique demonstrates superior knee stability, functional outcomes (e.g. return to sport ability), and lower ACL re-tear rates.
详细描述
Anterolateral ligament(ALL) combined with anterior cruciate ligament reconstruction(ACL) has become more and more popular in recent years, as ALL could protect the ACL graft in tibial internal rotation, and prevent the ACL graft from rupture. Cottet et al. proposed a minimal invasive method with Y-figure construct of ALL, without acquiring additional graft from the patient. Their data showed significant lower graft re-rupture rate and faster return-to-sport(RTS). There are many different techniques of ACL combined ALL reconstruction. While these methods mostly are single bundle ACL combined ALL reconstruction. Previous cadaver studies told that the anterior cruciate ligament is composed of anteromedial and posterolateral bundle. It had been debated between single bundle and double bundle ACL reconstruction for years. As a result, it is meaningful to compare the clinical outcomes between ALL combined with single bundle or double bundle ACL reconstruction. Our studies included MRI image, arthrometer measurement and optical motion capture system. We hope to compare the clinical outcomes and sports function between A: single bundle ACL combined ALL reconstruction and B: double bundle ACL combined ALL reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients plan to receive ACL surgery
- •at least 18 years old
排除标准
- •Presented history of the injured leg or congenital abnormality
结局指标
主要结局
Functional performance and return to sport
时间窗: Preoperative, 6 months, 1 year
Lower limb muscle strength
Knee ligament stability:
时间窗: Preoperative, 6 months, 1 year
Anterior tibial translation measured using a ligament arthrometer (GNRB) to objectively quantify anteroposterior knee laxity
Knee ligament stability clinical evaluation
时间窗: Preoperative, 6 months, 1 year
Lachman test
Imaging
时间窗: Preoperative, 1 year
Pre- and post-operative X-ray analysis to assess bone tunnels position
Patient-reported outcome measures (PROMs)
时间窗: Preoperative, 3 months, 6 months, 9 months, 1 year
International Knee Documentation Committee (IKDC) subjective score. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
次要结局
未报告次要终点