Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study — STAbiLiTY  

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title: Multicenter Randomized Clinical Trial Comparing Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis in Individuals Who Are At High Risk of Graft Failure.

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to compare outcomes (failure, function, strength, range of motion and quality of life) between patients who receive the usual anterior cruciate ligament (ACL) reconstructive surgery and patients who receive anterior cruciate ligament reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in young individuals who return to pivoting contact sports following ACL reconstruction. This study is designed to look at whether or not adding this extra tendon repair reduces the risk of graft failure in this population.

Clinical Trial Description

This study is a pragmatic study for a parallel groups, randomized clinical trial in which 600 patients with anterior cruciate ligament insufficiency who are undergoing surgery, are randomly allocated to either ACL reconstruction alone (control) or ACL reconstruction with lateral extra-articular tenodesis (experimental). Surgeons, data collectors, and the data analyst will be blind to group allocation. The primary outcome is rate of failure. Secondary outcomes include disease specific quality of life, return to function and sport. Patients are followed for two years postoperative. ;

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

• NCT number: NCT02018354
• Study type: Interventional
• Source: Western University, Canada
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2014
• Completion date: March 2025