Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341192
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-03-18
Brief Title:
Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
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:
2024-03
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 eg 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 eg return to sport ability and lower ACL re-tear rates
Detailed Description:
Anterolateral ligamentALL combined with anterior cruciate ligament reconstructionACL 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-sportRTS 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:
None
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?:
None
Is an FDA AA801 Violation?:
None