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

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Reconstruction
• Interventions: Procedure: Double-bundle ACL combined anterolateral ligament reconstruction; Procedure: Single-bundle ACL combined anterolateral ligament reconstruction

• Registration Number: NCT06341192
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-02
• Study Start: 2024-06-26
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2026-08-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients plan to receive ACL surgery
• at least 18 years old

Exclusion Criteria

• Presented history of the injured leg or congenital abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double bundle ACL combined anterolateral ligament reconstruction	Double-bundle ACL combined anterolateral ligament reconstruction	ACL reconstruction with triple folded semitendinosus and non folded gracilis and fibertape
Single bundle ACL combined anterolateral ligament reconstruction	Single-bundle ACL combined anterolateral ligament reconstruction	Single bundle ACL combined anterolateral ligament reconstruction

Primary Outcome Measures

Name	Time	Method
Patient-reported outcome measures (PROMs)	Preoperative, 3 months, 6 months, 9 months, 1 year	SANE score, The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline
Functional performance and return to sport	Preoperative, 6 months, 1 year	Lower limb symmetry index
Knee ligament stability:	Preoperative, 6 months, 1 year	Anterior tibial translation measured using a ligament arthrometer (GNRB) to objectively quantify anteroposterior knee laxity
Imaging	Preoperative, 1 year	Pre- and post-operative MRI analysis to assess graft ligamentization.
Knee ligament stability clinical evaluation	Preoperative, 6 months, 1 year	Anterior drawer test

Trial Locations

Locations (1)

Chang Gung memorial hospital; 🇨🇳 Taoyuan, Taiwan