Dual or single tendon anterior cruciate ligament reconstruction: a randomized controlled trial (DOSTAR study)

This is a prospective randomized controlled trial (RCT) comparing patient outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with one of two hamstring autograft constructs: 1) a graft constructed by folding a single hamstring tendon (harvested from the semitendinosus) four times (ST, 4 strand), or 2) a graft constructed by folding two hamstring tendons (harvested from the semitendinosus and gracilis tendons) two or three times (STG, 4/6 strand - the amount of folds of the harvested graft will be dependent on achieving the required minimum graft diameter specific to the patient). The intervention (the surgical procedure with one of the two graft types) will be administered by the treating orthopaedic surgeon. While both constructs are generally used interchangeably, for the purpose of trial registration the 'intervention' is the ST 4 strand surgical graft construct. The surgical time for both techniques remains the same, and takes approximately 45 minutes in length (this is extended approximately 15-20 minutes for concomitant meniscal repair, undertaken if required). 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). Following surgery, a standardized rehabilitation program will be followed by all patients, monitored by the patient's individual therapist. This rehabilitation program will require therapist visits 1-2 times per week as required over the initial 12 weeks (as is the case through standard clinical practice), followed by periodic supervised therapy from 3-9 months post-surgery. Initially, all patients who do not have meniscal repair will be permitted to weight bear as tolerated using crutches. Where meniscal pathology and subsequent repair dictates restricted weight bearing or loaded range of motion, the meniscus pathology will govern this progress until full weight bearing is allowable. 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.