Abstract

Background The widespread historical abandonment of lateral extra-articular procedures in ACL-injured knees occurred due to concerns about high rates of adverse events. Recently there has been a resurgence in popularity of lateral extra-articular procedures and this warrants an urgent evaluation of their safety profile. Hypothesis/Purpose The aim of this study was to perform an interim analysis of the ongoing (blinded for journal review) randomized controlled trial in order to determine whether combined ACL and anterolateral ligament reconstruction (ACL + ALLR) is associated with an increased rate of adverse outcomes when compared to isolated ACL reconstruction (ACLR). The hypothesis was that there would be no significant difference between groups at a minimum follow-up of one year. Study Design Randomized Controlled Trial Methods Recruitment was commenced in November 2016. Patients scheduled for ACL reconstruction were randomized to either isolated ACL reconstruction (bone-patella tendon-bone autograft) or combined ACL + ALLR (hamstring tendon autograft). All patients with a minimum follow-up of one year, in March 2019 were included. Complications and re-operations, knee laxity parameters, range of motion, Tegner, Lysholm, IKDC and KOOS scores were evaluated. Results Deux cent vingt quatre patients (112 in each group) with a mean follow-up 12.3 ± 1.9 (range 12 to 19) months formed the study population. There was a significantly higher rate of re-operation for cyclops syndrome in the isolated ACL group (B-PT-B 8.9 %, ACL + ALLR 0 %, p = 0.0012). There was no significant difference in the frequency of graft rupture (B-PT-B 5.4 %, ACL + ALLR 0.9 %, p = 0.1191), range of motion deficits, pain, or re-operation for meniscectomy between groups. There were no cases of post-operative infection, venous thromboembolism, or arthrofibrosis. Subjective IKDC (81.2 vs. 86.8, p = 0.0048), Lysholm (88 vs. 92, p = 0.0131) and some components of KOOS were significantly better in the ACL + ALL group. Conclusion This study demonstrates no evidence of an increased risk of adverse events after combined ACL + ALL reconstruction when compared to isolated ACL reconstruction with a B-PT-B graft. The trend towards a reduced graft rupture rate and significantly better subjective IKDC, Lysholm and KOOS scores with the combined procedure is consistent with the previous literature and expected to be more pronounced at the end of the overall study period.

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