Soft-tissue quadriceps tendon autograft during primary anterior cruciate ligament reconstruction in Skeletally-immature patients vs. Hamstrings: A protocol for a multi-centre randomized controlled trial.

BACKGROUND: ACL tears in skeletally-immature patients are often treated surgically using soft-tissue autografts to offset increased risks of cartilage, meniscus and physeal injuries. Despite technological innovation, there remains a high failure rate among active young patients. We present a randomized controlled trial (RCT) to evaluate the soft-tissue quadriceps autograft compared to the standard hamstring autograft to treat primary ACL tears in the pediatric population.

METHODS: This international RCT will evaluate 352 skeletally-immature patients between the ages of 10-18 years undergoing primary ACL reconstruction to compare the effect of hamstring versus soft-tissue quadriceps autografts on ACL failure rate as a primary outcome, and return to sport, knee function, knee pain, health-related quality of life and health utility, range of motion and stability, and other adverse events at 24 months as secondary outcomes. Follow-up will occur at 6 weeks and 6, 12, 18, and 24 months postoperatively.

DISCUSSION: This trial will inform the optimal primary surgical management for ACL injuries as it pertains to all soft-tissue graft selection, to not only reduce the relatively high failure rates, but also improve the function and return-to-sports in this young, active population.

TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov (NCT03896464) on March 27th, 2019.