MedTrace Logo

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

NCT03896464 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-03-30

No results posted yet for this 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.

Conditions

  • ACL - Anterior Cruciate Ligament Rupture

Interventions

PROCEDURE

Soft tissue hamstring autograft

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

PROCEDURE

Quadriceps tendon autograft

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

Sponsors & Collaborators

  • Canadian Orthopaedic Foundation

    collaborator OTHER

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McMaster University

    lead OTHER

Principal Investigators

  • Darren de SA, MD, FRCSC · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2030-01-01
Completion
2030-01-01

Countries

  • Canada
  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03896464 on ClinicalTrials.gov