NCT03896464

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jan 2020Jan 2030

First Submitted

Initial submission to the registry

March 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

10 years

First QC Date

March 27, 2019

Last Update Submit

March 25, 2025

Conditions

ACL - Anterior Cruciate Ligament Rupture

Keywords

AutograftSoft-tissue hamstringQuadriceps Tendon

Outcome Measures

Primary Outcomes (1)

  • Rate of ACL failure

    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).

    2 years

Secondary Outcomes (7)

  • Rate of Return to Sport

    2 years

  • Patient Reported Knee Function

    2 years

  • Knee Pain

    2 years

  • Health-Related Quality of Life

    2 years

  • Psychological Readiness to Return-to-Sport

    2 years

  • +2 more secondary outcomes

Study Arms (2)

Soft-tissue hamstring

ACTIVE COMPARATOR

All patients in the study will undergo arthroscopic-assisted, single-bundle, complete transphyseal, anatomic primary ACL reconstruction at the discretion of the surgeon, considering the individual patient's age, physeal status, and anticipated years of growth remaining to skeletal maturity. Patients in this arm will undergo soft-tissue autograft reconstruction using hamstrings (i.e. semitendinosus and/or gracilis) grafts. Grafts will be secured on the femur and tibia according to surgeon preference, given literature demonstrating no clear superior method for graft fixation.

Procedure: Soft tissue hamstring autograft

Quadriceps tendon

ACTIVE COMPARATOR

Patients in this arm will undergo soft-tissue autograft reconstruction using all-soft-tissue quadriceps (i.e. full or partial thickness) grafts. Grafts will be secured on the femur and tibia according to surgeon preference, given literature demonstrating no clear superior method for graft fixation.

Procedure: Quadriceps tendon autograft

Interventions

Soft tissue hamstring autograftPROCEDURE

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

Soft-tissue hamstring
Quadriceps tendon autograftPROCEDURE

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

Quadriceps tendon

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged 10-18 years.
  • History, physical exam, and magnetic resonance imaging (MRI) or arthroscopic image confirmation of ACL insufficiency.
  • Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction.
  • X-ray or MRI evidence of skeletal immaturity (i.e., open physes) based on imaging that is closest to the time of injury (and correlated with standard bone age left hand posteroanterior (PA) radiographs).
  • Patient involved in sport (competitive and/or recreational level) prior to injury.
  • Patient and parent/guardian speak, read, and understand the language of the clinical site.
  • Patient and parent/guardian provide informed consent and/or assent.

You may not qualify if:

  • Evidence (i.e. radiographic and/or arthroscopic) of International Cartilage Repair Society (ICRS) Cartilage Lesion Classification System Grade 2 (i.e., lesions extending down to 50% of the cartilage depth) and higher osteoarthritis that is symptomatic, requiring treatment other than debridement or microfracture.
  • Tibial eminence/spine fractures treated surgically.
  • Concomitant collateral, posterior cruciate, and/or cartilage pathology requiring surgical reconstruction and/or advanced restoration techniques (i.e., osteochondral allograft or autograft transfer, matrix-induced autologous chondrocyte implantation, particulate juvenile articular cartilage allograft transplantation).
  • Previous ACL reconstruction in the affected knee or contralateral knee.
  • Previous distal femur and/or proximal tibial/fibular physeal injury in the affected knee or contralateral knee.
  • Allograft or allograft-augmentation, or synthetic augmentation of the ACL reconstruction.
  • Biological-augmentation of the ACL reconstruction (i.e. platelet-rich-plasma, fibrin clot, reinforced bioinductive implants, etc.).
  • ACL reconstruction utilizing synthetic grafts.
  • Primary ACL repair.
  • Patient diagnosed with inflammatory arthropathy.
  • Significant medical co-morbidities (requiring daily assistance for activities of daily living).
  • Patient, parent/guardian, and/or clinical investigator believe the patient will have difficulty maintaining follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

Women's College Hospital/Research Institute

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Shriners Hospitals for Children - Canada

Montreal, Quebec, H4A 0A9, Canada

RECRUITING

Kobe University

Kobe, Japan

RECRUITING

Related Publications (1)

  • Ayeni OR; SQuASH Investigators. 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. J Orthop Surg Res. 2025 Dec 1;21(1):6. doi: 10.1186/s13018-025-06534-0.

    PMID: 41327264DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Darren de SA, MD, FRCSC

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darren de SA, MD, FRCSC

CONTACT

9059232126darren.desa@medportal.ca

Nicole Simunovic, MSc

CONTACT

(289) 237-3224simunon@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Autograft donation incisions will be covered with adhesive bandages for clinical outcome assessment by the attending physician. The assessor will perform a physical assessment of the patient's knees, including range of motion and laxity.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 1, 2019

Study Start

January 1, 2020

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)CA(5)