STABILITY
Research type
Research Study
Full 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.
IRAS ID
152174
Contact name
Tim Spalding
Contact email
Sponsor organisation
UHCW NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
The purpose of this study is to compare outcomes (function, strength, range of motion and quality of life) between patients who receive the usual anterior cruciate ligament (ACL) reconstructive surgery to patients who receive anterior cruciate ligament reconstructive surgery with a lateral extra-articular tenodesis. A lateral extra-articular tenodesis is the creation of a new ligament-like structure using a piece of the Iliotibial band on the outside of the knee. The usual standard of care for an ACL tear is ACL reconstruction without this lateral extra-articular tenodesis (new ligament-like structure). Some studies have shown high graft failure rates (which means the ACL will 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 structure reduces the risk of graft failure in this population. To determine whether one procedure is better than the other, patients will be randomised to one of the surgery groups. Six hundred (600) patients will take part in this study at different centres around the world. In the UK we will aim to recruit one hundred (100) patients; approximately 50 per group.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0398
Date of REC Opinion
11 Nov 2015
REC opinion
Favourable Opinion