NCT06341192

Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction

Clinical Comparison and Motion Analysis of Sports Function Between Combined Anterolateral Ligament Reconstruction With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * Undergo pre-operative MRI imaging, ligament stability testing, and motion analysis evaluations * Be randomly assigned to either: * Single-bundle ACL + ALL reconstruction * Double-bundle ACL + ALL reconstruction * Receive the assigned surgical procedure * 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.

Detailed description

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.

Conditions

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
PROCEDURE	Single-bundle ACL combined anterolateral ligament reconstruction	Single-Bundle ACL + ALL Reconstruction Group: Patients in this group will undergo reconstruction of the anterior cruciate ligament (ACL) using a single-bundle graft technique. In addition, they will have the anterolateral ligament (ALL) reconstructed using a portion of the same graft material. The single ACL bundle is typically positioned to replicate the anatomic footprint of the native ACL. For the ALL reconstruction, a commonly used technique is the Sonnery-Cottet ALL reconstruction using a gracilis tendon graft. This combines an intra-articular ACL reconstruction with an extra-articular lateral tenodesis to improve rotational instability.
PROCEDURE	Double-bundle ACL combined anterolateral ligament reconstruction	Double-Bundle ACL + ALL Reconstruction Group: Patients in this group will undergo anatomic double-bundle ACL reconstruction using two graft bundles to more anatomically replicate the native ACL\'s anteromedial and posterolateral bundles. Like the single-bundle group, they will also have supplemental ALL reconstruction performed using a portion of the graft material. The double-bundle ACL reconstruction aims to better restore the ACL\'s complex anatomic footprint and bundles\' tension patterns.

Timeline

• Start date: 2024-06-26
• Primary completion: 2026-08-31
• Completion: 2026-10-31
• First posted: 2024-04-02
• Last updated: 2025-09-25

Locations

1 site across 1 country: Taiwan