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Recruiting NCT03896464

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

No phase Interventional ACL - Anterior Cruciate Ligament Rupture

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Soft tissue hamstring autograft, Quadriceps tendon autograft.
Who it may be relevant to
Registry conditions: ACL - Anterior Cruciate Ligament Rupture. Basic parameters: 10 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Rate of ACL failure [Time frame: 2 years]
Secondary outcome measures (7)
  • Rate of Return to Sport [Time frame: 2 years]
  • Patient Reported Knee Function [Time frame: 2 years]
  • Knee Pain [Time frame: 2 years]
  • Health-Related Quality of Life [Time frame: 2 years]
  • Psychological Readiness to Return-to-Sport [Time frame: 2 years]
  • Range of Motion [Time frame: 2 years]
  • Adverse Events [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 5 centers
  • McMaster University — Hamilton
  • Children's Hospital of Eastern Ontario — Ottawa
  • Women's College Hospital/Research Institute — Toronto
  • CHU Sainte-Justine — Montreal
  • Shriners Hospitals for Children - Canada — Montreal
Japan · 1 center
  • Kobe University — Kobe

Publications

  • 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 41327264

Identifiers

NCT: NCT03896464 · SQuASH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗