Actively Recruiting

Phase Not Applicable
Age: 10Years - 18Years
All Genders
ID03896464

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

Research Sites

N/A

Total Duration

On this page

Sponsors

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

Regular follow-up visits over 2 years

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

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Research Team

D

Darren de SA, MD, FRCSC

N

Nicole Simunovic, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Olufemi R Ayeni, SQuASH Investigators

https://pubmed.ncbi.nlm.nih.gov/41327264