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NCT Number: NCT06341192

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Reconstruction Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung memorial hospital

Taoyuan, taoyuan, 333, Taiwan

Location status: Recruiting

Location contact

Cheng-Pang Yang, Dr

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Presented history of the injured leg or congenital abnormality

Treatment and study plan

Single-bundle ACL combined anterolateral ligament reconstruction

Procedure

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.

Double-bundle ACL combined anterolateral ligament reconstruction

Procedure

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.

Primary outcomes

  1. Patient-reported outcome measures (PROMs)

    Time frame: 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).

  2. Patient-reported outcome measures (PROMs)

    Time frame: Preoperative, 3 months, 6 months, 9 months, 1 year

    Marx's activity score;The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. From 0 point(the worst) to 16 points(the best).

  3. Patient-reported outcome measures (PROMs)

    Time frame: 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

  4. Knee ligament stability:

    Time frame: Preoperative, 6 months, 1 year

    Anterior tibial translation measured using a ligament arthrometer (GNRB) to objectively quantify anteroposterior knee laxity

  5. Knee ligament stability clinical evaluation

    Time frame: Preoperative, 6 months, 1 year

    Lachman test

  6. Knee ligament stability clinical evaluation

    Time frame: Preoperative, 6 months, 1 year

    pivot shift test

  7. Knee ligament stability clinical evaluation

    Time frame: Preoperative, 6 months, 1 year

    Anterior drawer test

  8. Functional performance and return to sport

    Time frame: Preoperative, 6 months, 1 year

    Lower limb muscle strength

  9. Functional performance and return to sport

    Time frame: Preoperative, 6 months, 1 year

    Lower limb symmetry index

  10. Imaging

    Time frame: Preoperative, 1 year

    Pre- and post-operative X-ray analysis to assess bone tunnels position

  11. Imaging

    Time frame: Preoperative, 1 year

    Pre- and post-operative MRI analysis to assess graft ligamentization.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng-Pang Dr. Yang

CONTACT

[email protected]

886-3-3281200 ext. 2163

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Acronym: ALLR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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