Quadriceps vs Hamstrings for ACL Surgery in Young Patients
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
Recruiting
N/AInterventional Study
ACL - Anterior Cruciate Ligament Rupture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 – 18
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
352 (estimated)
Sponsor
McMaster University · Other
Who this trial is looking for
This trial is looking for young people aged 10 to 18 who need surgery for a torn ACL. Participants will have a choice between using a tendon from their quadriceps or hamstrings for the surgery and will be followed for 24 months to see how well the surgery works.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 10-18 years.
I have a confirmed torn ACL.
I am suitable for ACL reconstruction surgery.
I have evidence of skeletal immaturity in X-ray or MRI.
I was involved in sports before my injury.
I can understand the language of the clinical site.
I provide informed consent and/or assent.
You may not be able to join if
I have a significant cartilage injury that needs more than minor treatment.
I have had surgery for a fracture in my knee.
I have other knee problems that need surgery.
I have had previous ACL surgery in either knee.
I have had a serious injury to my knee growth plates.
I have had synthetic materials used in my previous knee surgery.
I have a condition that causes joint inflammation.
I have serious medical issues that need daily help.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.