Recruiting

Quadriceps vs. Hamstrings

Sponsor:

McMaster University

Code:

NCT03896464

Conditions

ACL - Anterior Cruciate Ligament Rupture

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Soft tissue hamstring autograft

Quadriceps tendon autograft

Study Details

Brief summary:

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

ACL - Anterior Cruciate Ligament Rupture

Study ID

NCT03896464

Start date

Jan 1, 2020

Status verified date

Mar, 2025

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

352 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

Interventions

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.

Primary outcome measure

  • Rate of ACL failure [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Darren de SA, MD, FRCSC

9059232126darren.desa@medportal.ca

Nicole Simunovic, MSc

(289) 237-3224simunon@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8N3Z5

Contacts

Darren de SA, MSc

darren.desa@medportal.ca

Nicole Simunovic, MSc

(289) 237-3224simunon@mcmaster.ca

Principal Investigator:

Darren de SA, MD

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Principal Investigator:

Sasha Carsen, MD

Women's College Hospital/Research Institute

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Principal Investigator:

Jihad Abouali, MD, FRCSC

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Principal Investigator:

Marie-Lyne Nault, MD, FRCSC

Shriners Hospitals for Children - Canada

Recruiting

Montréal, Quebec, Canada, H4A 0A9

Principal Investigator:

Justin Drager, MD, FRCSC

More Information

Sponsor

McMaster University

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Keywords

  • Autograft
  • Soft-tissue hamstring
  • Quadriceps Tendon

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McMaster University on 2025-03-30.