RecruitingNot ApplicableNCT03896464

Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings

Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH): A Multi-Centre Randomized Controlled Trial


Sponsor

McMaster University

Enrollment

352 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This international randomized controlled trial compares two types of tendon grafts used to reconstruct torn ACLs in children and teenagers: the traditional hamstring tendon autograft versus the quadriceps tendon autograft, which has shown promise in adults but hasn't been rigorously studied in younger patients. The goal is to determine which graft leads to better outcomes in terms of re-tear rates, return to sport, knee function, pain, and quality of life over 24 months. Eligible participants are children and adolescents aged 10–18 with confirmed ACL insufficiency, evidence of open growth plates (skeletally immature), and a history of playing sport before their injury. Participation involves surgery followed by two years of follow-up appointments to track recovery and knee health. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESoft tissue hamstring autograft

Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.

PROCEDUREQuadriceps tendon autograft

Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.


Locations(6)

McMaster University

Hamilton, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Women's College Hospital/Research Institute

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

Shriners Hospitals for Children - Canada

Montreal, Quebec, Canada

Kobe University

Kobe, Japan

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NCT03896464


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