STABILITY 2
Research type
Research Study
Full title
STABILITY 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs. Quad Tendon
IRAS ID
280567
Contact name
Andrew Metcalfe
Contact email
Sponsor organisation
University Hospital Coventry & Warwickshire
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Anterior cruciate ligament (ACL) rupture is one of the most common injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the ACL reconstructed knee. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post traumatic OA, additional surgical procedures and reduced physical function and QOL. As such, strategies to reduce ACLR failure are critical to improving outcomes after ACL rupture.
The aim of this study is to find out if the rates of rotational laxity and ACL graft failure can be reduced by determining the optimal autograft choice for ACLR as well as the need for a LET.
STABILITY 2 is a 21-site multicenter, international, randomized clinical trial that will randomly assign 1200 individuals with an ACL deficient knee who are at high risk of re-injury to anatomic anterior cruciate ligament reconstruction (ACLR) using bone patellar tendon bone (BPTB) or quadriceps tendon (QT) autograft with or without a lateral extra-articular tenodesis (LET).
The study population will consist of 1200 young, active individuals from the US, Canada and Europe. Eligible patients will have an ACL deficient knee, be skeletally mature but ≤25 years of age, and meet ≥2 of the following criteria: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater, have generalized ligamentous laxity (Beighton score of ≥4) and/or genu recurvatum >10 degrees.
Patients will have a knee x-ray and MRI to confirm diagnosis. We will ask patients about symptoms, activities, participation and QOL, measure of range of motion and muscle function and return to pre-injury sports in questionnaires. Follow up visits with the surgeon will occur at 6 weeks & 3, 6, 12 & 24 months after surgery.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
21/EE/0263
Date of REC Opinion
25 Feb 2022
REC opinion
Further Information Favourable Opinion