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

NCT06341192 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Injuries
  • Anterior Cruciate Ligament Reconstruction

Interventions

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Cheng-Pang Dr. Yang · Cheng Gung memorial hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2026-08-31
Completion
2026-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06341192 on ClinicalTrials.gov