Suture-tape augmentation of anterior cruciate ligament reconstruction: a randomised controlled trial

This is a parallel arm, 1:1 allocated randomised controlled trial comparing anterior cruciate ligament (ACL) reconstruction with suture tape augmentation of the graft to standard ACL reconstructive technique. Whilst many ACL reconstruction patients return to sport, a significant minority suffer complications of graft rupture, particularly during the early return to sport and rehabilitative period. Inherent weakness of the graft in withstanding the loads applied during these periods has been attributed to graft failure risk, as well as residual laxity (looseness) of the knee. Recently, the use of suture-tape to run alongside the graft (or augment) has emerged to increase the strength of the new ACL, however, there is little comparative evidence available regarding this technique, particularly in its capacity to reduce residual knee laxity, or improve patient outcomes after ACLR. We aim to investigate the use of this technique by randomly allocating ACL reconstructive patient to receive it, or standard technique (the same surgery without the additional suture). We will compare the outcomes following this by testing the looseness of the knee at standard time points (3 months, 12 months and 2 years) compared with the patients other 'normal' knee. We will also compare patient reported outcomes (via patient delivered surveys), findings on examination of the knee, return to sport times and rates and complications such as the need for return to surgery, and failure of the ACL reconstruction. We will perform this study with an aim to improve our understandings about the potential benefit or harms associated with tape augmentation, with the hope that it will inform the use of this technique in future patients needing to undergo ACL reconstruction to return to sport. We hypothesise that patients whose knees are reconstructed with suture-tape augmented grafts will have a smaller difference between operative and non operative sides at two years after surgery, compared with patients who undergo standard ACL reconstruction. Secondly, we hypothesise that patients with tape augmented ACL grafts will return to sport sooner, and have improved patient reported outcome measures during the follow up period (2 years).