Comparing quadriceps tendon and hamstring autografts for ACL reconstruction in young patients
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings (SQuASH): A Multi-Centre Randomized Controlled Trial
This study is testing whether using quadriceps tendon grafts instead of hamstring grafts for ACL surgery can lead to better recovery for young patients aged 10-18.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 6 sites (Hamilton, Ontario and 5 other locations) |
| Trial ID | NCT03896464 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of quadriceps tendon autografts compared to traditional hamstring autografts in pediatric patients undergoing ACL reconstruction. It involves a randomized controlled design with 352 skeletally-immature participants aged 10-18 years, who will be assessed for ACL insufficiency through clinical evaluations and imaging. The study seeks to determine if the quadriceps tendon can provide better outcomes in this population, as it has shown promise in adults but lacks extensive pediatric research. The trial will be conducted across multiple centers in Canada, ensuring a diverse participant pool.
Who should consider this trial
Good fit: Ideal candidates are skeletally-immature patients aged 10-18 years with confirmed ACL insufficiency and a history of sports participation.
Not a fit: Patients with significant cartilage lesions or symptomatic osteoarthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective surgical option for young athletes with ACL injuries.
How similar studies have performed: While the quadriceps tendon has shown favorable outcomes in adults, this approach in pediatric patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Patients aged 10-18 years. 2. History, physical exam, and magnetic resonance imaging (MRI) or arthroscopic image confirmation of ACL insufficiency. 3. Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction. 4. 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). 5. Patient involved in sport (competitive and/or recreational level) prior to injury. 6. Patient and parent/guardian speak, read, and understand the language of the clinical site. 7. Patient and parent/guardian provide informed consent and/or assent. Exclusion Criteria 1. 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. 2. Tibial eminence/spine fractures treated surgically. 3. 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). 4. Previous ACL reconstruction in the affected knee or contralateral knee. 5. Previous distal femur and/or proximal tibial/fibular physeal injury in the affected knee or contralateral knee. 6. Allograft or allograft-augmentation, or synthetic augmentation of the ACL reconstruction. 7. Biological-augmentation of the ACL reconstruction (i.e. platelet-rich-plasma, fibrin clot, reinforced bioinductive implants, etc.). 8. ACL reconstruction utilizing synthetic grafts. 9. Primary ACL repair. 10. Patient diagnosed with inflammatory arthropathy. 11. Significant medical co-morbidities (requiring daily assistance for activities of daily living). 12. Patient, parent/guardian, and/or clinical investigator believe the patient will have difficulty maintaining follow-up.
Where this trial is running
Hamilton, Ontario and 5 other locations
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Recruiting)
- Women's College Hospital/Research Institute — Toronto, Ontario, Canada (Recruiting)
- CHU Sainte-Justine — Montreal, Quebec, Canada (Recruiting)
- Shriners Hospitals for Children - Canada — Montreal, Quebec, Canada (Recruiting)
- Kobe University — Kobe, Japan (Recruiting)
Study contacts
- Principal investigator: Darren de SA, MD, FRCSC — McMaster University
- Study coordinator: Darren de SA, MD, FRCSC
- Email: darren.desa@medportal.ca
- Phone: 9059232126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.