Trial to determine if the addition of a soft tissue tightening procedure to a particularly unstable knee following anterior cruciate ligament reconstruction, improves the outcome.

Following and ACL reconstruction, approximately one quarter of patients are not happy with the outcome and do not return to their previous level of activity. The most common cause of this persistent instability following the ACL reconstruction. The best available clinical test for anterolateral instability, is the pivot shift test. In some patients, even following an optimally performed ACL reconstruction, there may be some persistent instability, or anterolateral rotator instability (ALRI) as evidenced by a persistent pivot shift maneuver. This may be caused by damage to anterolateral extra-articular structures. Reconstruction of these anterolateral structures has been shown to be able to improve the stability of the knee, and outcome following revision ACL reconstruction. Dr. Mark Porter, has already demonstrated that the addition of the modified “iliotibial tenodesis” procedure, to those patients with a persistent pivot shift following revision ACL reconstruction improved the stability of the knee, and functional outcome (Porter et al Am J Sports Med 2018). However, it is not known if this is case when there is a persistent pivot shift, following primary ACL reconstruction. The goal of this study is to determine if the functional outcomes are improved when the ITBT procedure is added to the ACL reconstructions in patients with a positive pivot shift test, following primary ACL reconstruction. The study is a RCT in which patients who meet the study criteria (skeletally mature, physically active, medically fit, no previous knee surgery, isolated ACL rupture at the time of surgery, pivot shift test one grade or more in the reconstructed knee greater than that of the un-injured opposite knee, no previous ACL injury or surgery in either knee) are randomized to either have this procedure added to their ACL reconstruction (group 1) or not (group 2). The randomization is performed using a computer program, at the time of surgery. The ACL reconstruction is performed in a standard manner and as described in the literature (Porter et al. OJSM) using ipsilateral autologous hamstrings, with interference screw fixation in both the femur and the tibia. The modified ITB tenodesis procedure (ITBT) is performed using a 10cm long incision of the distal ITB and its insertion onto Gerdy’s tubercle. A 1cm distally based strip of the ITB is harvest. The free end is prepared with a locking whip-stitch and the passed from superficial to deep around the proximal lateral collateral ligament of the knee, and secured into a bone tunnel at the posterior aspect of Gerdy’s tubercle. The ITBT is tensioned to correct the pivot shift to 0 before securing with an interference screw in the tunnel at Gerdy’s tubercle. All interference screws are made of biohydroxy-apatite and undergo osseous integration within 12 months of surgery. The outcome of interest is the following patient-reported outcomes, the IKDC (international knee documentation committee), the KOOS (knee osteoarthritis and injury outcome study), the Lysholm score, and Tegner activity score, all of which have been validated for this use and have been used before in similar research. The questionnaires take patients approximately 15 minutes to complete. The PROs are completed prior to surgery, and again at 1, 2, 5, 10 and 15 years post surgery. The data will be analyses using statistical analysis, with P<0.05 used to denote statistical significance. The occurrence of any complications and / or recurrence of ACL injury is also noted at each of these time intervals.