Who is eligible for clinical trial NCT03896464?

Participants must meet the protocol's inclusion criteria for ACL - Anterior Cruciate Ligament Rupture. The stated age range is 10 Years to 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03896464 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-03-25

Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (NCT03896464)

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

🟢 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: McMaster University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (13 items).

Location: McMaster University — Hamilton, Ontario

Age range: 10 Years to 18 Years

🧪 Interventions in This Study

Soft tissue hamstring autograft (PROCEDURE)
Quadriceps tendon autograft (PROCEDURE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

McMaster University — Hamilton, Ontario
Children's Hospital of Eastern Ontario — Ottawa, Ontario
Women's College Hospital/Research Institute — Toronto, Ontario
CHU Sainte-Justine — Montreal, Quebec
Shriners Hospitals for Children - Canada — Montreal, Quebec
Kobe University — Kobe,

📞 Contact the Study Coordinator

Phone: (905) 923-2126

Email: darren.desa@medportal.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗