Self-reported functional recovery after reconstruction versus repair in acute anterior cruciate ligament rupture (ROTOR): a randomized controlled clinical trial

BACKGROUND: Anterior cruciate ligament (ACL) reconstruction is today’s surgical gold standard for ACL rupture. Although it provides satisfactory results, not all patients return to their previous activity level and moreover, early posttraumatic osteoarthritis is not prevented. As such, a renewed interest has emerged in ACL suture repair combined with dynamic augmentation. Compared to ACL reconstruction, the hypothesized advantages of ACL suture repair are earlier return to sports, reduction of early posttraumatic osteoarthritis and preservation of the patient’s native ACL tissue and proprioceptive envelope of the knee. In recent literature, ACL suture repair combined with dynamic augmentation tends to be at least equally effective compared to ACL reconstruction, but no randomized comparative study has yet been conducted. METHODS/DESIGN: This study is a prospective, stratified, block randomized controlled trial. Forty-eight patients with an ACL rupture will be assigned to either a suture repair group with dynamic augmentation and microfracture of the femoral notch, or an ACL reconstruction group with autologous semitendinosis graft and all-inside technique. The primary objective is to investigate the hypothesis that suture repair of a ruptured ACL results in at least equal effectiveness compared with an ACL reconstruction in terms of patient self-reported outcomes (IKDC 2000 subjective scale) 1 year postoperatively. Secondary objectives are to evaluate patient self-reported outcomes (IKDC 2000, KOOS, Tegner, VAS), re-rupture rate, rehabilitation time required for return to daily and sports activities, achieved levels of sports activity, clinimetrics (Rolimeter, LSI, Isoforce) and development of osteoarthritis, at short term (6 weeks, 3, 6 and 9 months and 1 year), midterm (2 and 5 years) and long term (10 years) postoperatively. DISCUSSION: A renewed interest has emerged in ACL suture repair combined with dynamic augmentation in the treatment of ACL rupture. Recent cohort studies show good short- and midterm results for this technique. This randomized controlled trial has been designed to compare the outcome of suture repair of a ruptured ACL, combined with DIS as well as microfracture of the femoral notch, with ACL reconstruction using autologous semitendinosus. TRIAL REGISTRATION: Clinical Trials Register NCT02310854 (retrospectively registered on December 1st, 2014).