Comparison of clinical outcomes in paediatric patients undergoing anterior cruciate ligament reconstruction with or without additional iliotibial band tenodesis

This is a prospective randomized controlled trial (RCT) comparing patient outcomes in paediatric patients undergoing anterior cruciate ligament reconstruction (ACLR) with or without a concomitant iliotibial band tenodesis. The intervention (the surgical procedure with or without a concomitant iliotibial band tenodesis) will be administered by the treating orthopaedic surgeon. While both options are available to patients through a standard clinical pathway and individual surgeons may perform ACLR either with or without tenodesis through their own standard clinical pathway, for the purpose of trial registration the 'intervention' will allude to ACLR with the additional tenodesis. The surgical time for ACLR lasts approximately 30 minutes, with the tenodesis adding an extra (approximately) 10-15 minutes to the operative procedure. The appropriate intervention will be ensured in all patients via internal monitoring by the research team, liaising with a specific member of the nursing team that is independent to the research study team and on-site for all surgeries). The ACLR procedure will be performed in a standardized fashion using a four-strand autologous hamstring autograft. If the diameter of the graft is found to be less than 8mm, semitendinosus will be tripled (5 strand graft) providing a greater graft diameter. Femoral tunnels will be drilled using an anteromedial portal technique, with femoral fixation provided by an Endobutton or equivalent. Tibial fixation will be provided by interference screw. For patients randomised to receive the concomitant tenodesis, this will also be performed in a standardized fashion. Specifically, surgeons will make an oblique skin incision between the lateral epicondyle and Gerdy’s tubercle, measuring approximately 5cm. A 1cm wide by 8cm long strip of ITB is fashioned, leaving the Gerdy’s tubercle attachment intact. A No. 1 vicryl whip suture is applied to the free end, leaving the needle attached. The graft is then tunnelled under the fibular collateral ligament (FCL) and attached to the femur with a Richards’ staple, just distal to the intermuscular septum, proximal to the femoral insertion of the FCL. Fixation is performed with the knee at 70° flexion, neutral rotation. Minimal tension is applied to the graft. The free end is then looped back onto itself and sutured using the No. 1 vicryl. Following surgery, a standardized rehabilitation program will be followed by all patients, monitored by the patient's individual physiotherapist, generally in a one-to-one environment. This rehabilitation program will require a therapist visit every 1-2 weeks, over the initial 12 weeks (as is the case through standard clinical practice), followed by periodic supervised therapy from 3-9 months post-surgery (these sessions after 3 months are once per 3-4 weeks. All supervised sessions last approximately 30-45 minutes, and are supplemented by a progressive home-based program. An attempt to monitor rehabilitation adherence will be made using an activity diary, combined with therapist-patient discussion at the time of supervised sessions. Briefly and, standardized across all patients, early in-patient exercises will focus on regaining knee range of motion (ROM), patella mobility and pain/swelling reduction. From 2-3 weeks post-surgery, out-patient rehabilitation (including the exact exercises, together with recommended sets, repetitions and loads) will be dictated by individual patient physical conditioning and progression. An initial focus on exercises to restore movement and bilateral functional weight bearing strength will be prescribed. From 6-weeks post-surgery, a focus on single leg strength capacity will be undertaken, with a criterion-based return to jogging, as well as jumping and hopping exercises from 3 months post-surgery.