Actively Recruiting
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
Led by McMaster University · Updated on 2025-03-30
352
Participants Needed
6
Research Sites
521 weeks
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
C
Canadian Orthopaedic Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
Who Can Participate
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 (open growth plates) on X-ray or MRI near time of injury
- Patient was involved in competitive or recreational sports before injury
- Patient and parent/guardian understand and speak 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 with symptoms needing treatment beyond debridement or microfracture
- Surgically treated tibial eminence/spine fractures
- Additional ligament or cartilage injuries requiring surgical reconstruction or advanced restoration
- Previous ACL reconstruction in either knee
- Previous physeal 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 arthropathy
- Significant medical conditions needing daily assistance
- Belief that patient will have difficulty maintaining follow-up by patient, guardian, or investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
McMaster University
Hamilton, Ontario, Canada, L8N3Z5
Actively Recruiting
2
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
3
Women's College Hospital/Research Institute
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
4
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
5
Shriners Hospitals for Children - Canada
Montreal, Quebec, Canada, H4A 0A9
Actively Recruiting
6
Kobe University
Kobe, Japan
Actively Recruiting
Research Team
D
Darren de SA, MD, FRCSC
CONTACT
N
Nicole Simunovic, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here