Trial Status: In Set-Up
Grant Start Date: 01-May-2024
Anterior Cruciate Ligament Stratified Accelerated Repair or Reconstruction Single blind randomised control trial for patients with proximal ACL injuries treatment with ACL repair v ACL reconstruction.
AIM:
To test the hypothesis that, in patients with recent proximal ACL ruptures, ACL repair is superior to ACL reconstruction at 24 months post intervention.
Background and rationale:
The knee is the most injured joint. The Anterior Cruciate Ligament (ACL) is one of the key ligaments in the knee. It provides joint stability, allows normal knee kinematics, and maintains knee function giving confidence to undertake everyday activities, manual work, and recreational sports. Traumatic injury to the ACL is common with an incidence of 1 in 3000 per year and can be substantially disabling.
There are different surgical options for people with an ACL injury. The most common is reconstruction, which uses tissue from other parts of the body, such as the hamstrings, to act as a replacement. This is a successful operation but does involve damage to bones from drilling holes, removal of tissue from elsewhere in the body, and does not keep any of the torn ligament which has potentially useful nerve endings. An alternative approach is to stitch the original ligament back together in a “repair” rather than reconstruction. By preserving the ligament, avoiding tissue harvest and bone drilling, ACL repair could provide faster recovery, better medium to long term stability, and might reduce likelihood of OA in the future.
It is thought that approximately 40% of ACL tears may be repairable. The tear pattern and potential for repair is determined by MRI and intraoperative assessment of the ligament. Time is considered a key factor allowing for the potential repair, and so surgery needs to be undertaken as soon as practicable [within six weeks for ACL STARR]. The evidence to support repair is weak or biased and an independent RCT is therefore needed.
STUDY DESIGN:
Our study is a pragmatic multi-centre, randomised, single blind trial. The study will be conducted in 286 patients, participants of which, will be individually randomised (1:1) intraoperatively, following suitability assessment, to receive either ACL repair or reconstruction from at least 20 secondary care sites with acute knee pathways in place.