Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-27 @ 4:38 PM
Study NCT ID:
NCT06341192
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2024-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLR
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: