Comparing quadriceps tendon and hamstring autografts for ACL reconstruction in young patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of quadriceps tendon autografts compared to traditional hamstring autografts in pediatric patients undergoing ACL reconstruction. It involves a randomized controlled design with 352 skeletally-immature participants aged 10-18 years, who will be assessed for ACL insufficiency through clinical evaluations and imaging. The study seeks to determine if the quadriceps tendon can provide better outcomes in this population, as it has shown promise in adults but lacks extensive pediatric research. The trial will be conducted across multiple centers in Canada, ensuring a diverse participant pool.

Why it matters

Who can join: the full rules

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.

Where it's running

• McMaster University
  Hamilton, Ontario, Canada Recruiting
• Children's Hospital of Eastern Ontario
  Ottawa, Ontario, Canada Recruiting
• Women's College Hospital/Research Institute
  Toronto, Ontario, Canada Recruiting
• CHU Sainte-Justine
  Montreal, Quebec, Canada Recruiting
• Shriners Hospitals for Children - Canada
  Montreal, Quebec, Canada Recruiting
• Kobe University
  Kobe, Japan Recruiting

Study contacts

• Principal investigator: Darren de SA, MD, FRCSC — McMaster University
• Study coordinator: Darren de SA, MD, FRCSC
• Email: darren.desa@medportal.ca
• Phone: 9059232126

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Strength training with blood-flow restriction after ACL reconstruction

  This trial will test whether adding blood flow restriction to light strength training helps people recovering from ACL reconstruction regain muscle, strength, and knee function during outpatient rehabilitation.

  Recruiting University Hospital, Bonn · Bonn, North Rhine-Westphalia · NCT07043569

• Conventional rehabilitation with or without digital therapy to restore quadriceps activation after ACL reconstruction

  This trial tests whether adding a smartphone-based digital therapy to standard physiotherapy helps adults recovering from ACL reconstruction overcome quadriceps muscle inhibition.

  Recruiting GCS Ramsay Santé pour l'Enseignement et la Recherche · Lyon, France · NCT07030764

• Microbial Profile of the Knee Joint During ACL Surgery

  This study tests whether advanced DNA sequencing can detect hidden knee infections or microbiome changes in people undergoing ACL reconstruction or ACL revision surgery.

  Recruiting GCS Ramsay Santé pour l'Enseignement et la Recherche · Lyon · NCT07009392

• Exercise with blood flow restriction for patients with complete ACL tears

  This study is testing if exercising with blood flow restriction can help people with complete ACL tears recover better than just standard treatment alone.

  Recruiting at 2 sites European University Cyprus · Nicosia and 1 other locations · NCT06727344

• Assessing soleus muscle strength in patients with ACL tears

  This study is testing the strength of a muscle in the calf of people with ACL tears to see how it compares to their uninjured leg and to healthy volunteers.

  Recruiting University of Liverpool · Liverpool · NCT06235736

• Optimizing graft selection for ACL reconstruction

  This study is testing which type of graft—quadriceps tendon, hamstring tendons, or patellar tendon—works best for helping young adults recover from their first ACL injury.

  Recruiting Hvidovre University Hospital · Hvidovre · NCT05342441

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.