Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
Condition(s) studied
Investigational drug(s) / intervention(s)
Soft tissue hamstring autograft: Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
Quadriceps tendon autograft: Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.
Study summary
To date, the use of the quadriceps tendon as an autograft option in primary paediatric Anterior Cruciate Ligament (ACL) reconstruction has not been well studied. The 2018 International Olympic Committee (IOC) Consensus Statement now outlines the quadriceps tendon as a possible autograft option. However, no Randomised Control Trial (RCT) has examined the efficacy of the quadriceps tendon autograft in primary paediatric ACL reconstruction compared to the historical "gold-standard" soft-tissue hamstring autograft in this population. In light of its evidence for favourable outcomes in the adult population, and the (albeit limited) evidence showing safety and promise in the paediatric population, clinical equipoise exists for assessing its impact on outcomes in paediatric patients at the index surgery. This is a parallel, international, multi-centre, blinded randomized controlled trial of 352 skeletally-immature (at the time of injury) patients (ages 10-18 years, inclusive) undergoing primary ACL reconstruction to compare the effect of autograft tendon choice (i.e. hamstring versus soft-tissue quadriceps) on the rates of ACL graft failure, return-to-sport, knee function, pain, health-related quality of life and health utility, psychological factors, range of motion and stability, and any other adverse events at 24 months.
Eligibility
Primary outcome measure(s)
- Rate of ACL failure — 2 years
ACL graft failure is a composite outcome defined by MRI confirmation of rupture and/or asymmetrical symptomatic laxity (i.e., positive Lachman and/or positive pivot shift).
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| McMaster University | Hamilton | Ontario | Recruiting |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | Recruiting |
| Women's College Hospital/Research Institute | Toronto | Ontario | Recruiting |
| CHU Sainte-Justine | Montreal | Quebec | Recruiting |
| Shriners Hospitals for Children - Canada | Montreal | Quebec | Recruiting |
| Kobe University | Kobe | Japan | Recruiting |
More McMaster University trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03896464 on ClinicalTrials.gov ↗ ← All trials in Canada