Clinical trial NCT06341192: Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction
Official title: Clinical Comparison and Motion Analysis of Sports Function Between Combined Anterolateral Ligament Reconstruction With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Reconstruction
Keywords: anterior cruciate ligament
anterolateral ligament
single bundle
double bundle
optical motion capture
graft rupture
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
* For the ALL reconstruction, a commonly used technique is the Sonnery-Cottet ALL reconstruction using a split graft.

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 purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Presented history of the injured leg or congenital abnormality

Primary outcomes:
measure: Patient-reported outcome measures (PROMs)
timeFrame: Preoperative, 3 months, 6 months, 9 months, 1 year
measure: Patient-reported outcome measures (PROMs)
timeFrame: Preoperative, 3 months, 6 months, 9 months, 1 year
measure: Patient-reported outcome measures (PROMs)
timeFrame: Preoperative, 3 months, 6 months, 9 months, 1 year
measure: Knee ligament stability:
timeFrame: Preoperative, 6 months, 1 year
measure: Knee ligament stability clinical evaluation
timeFrame: Preoperative, 6 months, 1 year
measure: Knee ligament stability clinical evaluation
timeFrame: Preoperative, 6 months, 1 year
measure: Knee ligament stability clinical evaluation
timeFrame: Preoperative, 6 months, 1 year
measure: Functional performance and return to sport
timeFrame: Preoperative, 6 months, 1 year
measure: Functional performance and return to sport
timeFrame: Preoperative, 6 months, 1 year
measure: Imaging
timeFrame: Preoperative, 1 year
measure: Imaging
timeFrame: Preoperative, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung memorial hospital
Study officials:
affiliation: Cheng Gung memorial hospital
name: Cheng-Pang Dr. Yang
role: PRINCIPAL_INVESTIGATOR
References:
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