Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
NCT ID: NCT03896464
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
352 participants
INTERVENTIONAL
2020-01-01
2030-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Soft-tissue hamstring
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.
Soft tissue hamstring autograft
Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
Quadriceps tendon
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.
Quadriceps tendon autograft
Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.
Interventions
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Soft tissue hamstring autograft
Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
Quadriceps tendon autograft
Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.
Eligibility Criteria
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Inclusion Criteria
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
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.
10 Years
18 Years
ALL
No
Sponsors
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Canadian Orthopaedic Foundation
OTHER
The Physicians' Services Incorporated Foundation
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Darren de SA, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Women's College Hospital/Research Institute
Toronto, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
Shriners Hospitals for Children - Canada
Montreal, Quebec, Canada
Kobe University
Kobe, , Japan
Countries
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Central Contacts
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Facility Contacts
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Sasha Carsen, MD
Role: primary
Ananya Pathak, MSc
Role: primary
Nathalie Jourdain
Role: primary
Nicolas Herrera, MSc
Role: primary
Kanto Nagai, MD, PhD
Role: primary
Other Identifiers
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SQuASH
Identifier Type: -
Identifier Source: org_study_id
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