Soft-tissue Quadriceps Autograft ACL Reconstruction in Skeletally Immature Patients Compared to Hamstring Autograft A Multi-Centre Randomized Controlled Trial
Led by McMaster University · Updated on 2025-03-30
352
Participants Needed
6
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M
McMaster University
Lead Sponsor
C
Canadian Orthopaedic Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of quadriceps tendon autografts compared to the traditional hamstring autografts for primary Anterior Cruciate Ligament (ACL) reconstruction in children and adolescents aged 10 to 18 years with immature skeletons. This randomized controlled trial aims to compare these two graft options on outcomes such as ACL graft failure rates, return to sport, knee function, pain, quality of life, psychological readiness, range of motion, and adverse events over a 24-month period. This study addresses the lack of prior randomized trials in pediatric patients despite promising adult data and emerging evidence supporting quadriceps tendon use in youth.
Participants will undergo arthroscopic-assisted, single-bundle, complete transphyseal ACL reconstruction with either a soft-tissue hamstring autograft or a soft-tissue quadriceps tendon autograft. The choice of graft fixation method is left to the surgeon's discretion based on current literature showing no clear superior fixation technique. Both study groups receive the same surgical technique differing only in the tendon used for reconstruction.
During the 24 months following surgery, patients will be monitored for ACL failure incidence, return to sport, knee pain and function, health-related quality of life, psychological readiness, range of motion, and any adverse events. Assessments will include clinical evaluations and patient-reported outcomes to comprehensively evaluate the impact of the graft choice. The study involves multiple international centers and aims to enroll 352 skeletally immature participants with confirmed ACL insufficiency who were active in sports prior to injury.
CONDITIONS
Brief Title
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
Who Can Participate
Age: 10Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
Patients aged 10-18 years
Confirmed ACL insufficiency by history, physical exam, and MRI or arthroscopic imaging
Suitable for anatomic, single-bundle arthroscopic-assisted ACL reconstruction
Evidence of skeletal immaturity with open growth plates confirmed by imaging
Active in competitive or recreational sports before injury
Patient and parent/guardian understand the clinical site's language
Patient and parent/guardian provide informed consent and/or assent
You will not qualify if you...
Cartilage lesions Grade 2 or higher requiring treatment beyond debridement or microfracture
Surgically treated tibial eminence or spine fractures
Other ligament or cartilage injuries needing advanced surgical restoration
Previous ACL reconstruction in either knee
Previous growth plate injury in distal femur or proximal tibia/fibula in either knee
Use of allograft, synthetic grafts, or biological augmentation in ACL reconstruction
Primary ACL repair procedures
Diagnosis of inflammatory joint disease
Significant medical conditions needing daily assistance
Anticipated difficulty maintaining study follow-up by patient, parent/guardian, or investigator
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Surgery day and immediate recovery period
Participants undergo arthroscopic-assisted, single-bundle ACL reconstruction using either soft-tissue hamstring or quadriceps tendon autografts as decided by the surgeon.
1 surgical procedure visit
Post-operative Follow-up
Duration - Up to 2 years
Participants are monitored for recovery, knee function, pain, and any adverse events following surgery.
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.