Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings

Launched by MCMASTER UNIVERSITY · Mar 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical options for repairing a torn anterior cruciate ligament (ACL) in children and teenagers aged 10 to 18 years. Specifically, it compares the use of the quadriceps tendon, which is a part of the thigh muscle, with the traditional hamstring tendon, which comes from the back of the thigh. The goal is to see which option leads to better results, such as fewer follow-up surgeries, a quicker return to sports, and improved knee function.

To participate in this study, eligible participants must have had a confirmed ACL injury and be active in sports before their injury. They should not have any other serious knee problems or previous knee surgeries that could affect the results. If selected, participants will undergo surgery using one of the two tendon options and will be followed closely to track their recovery and overall outcomes. This trial is important because it could help determine the best way to treat ACL injuries in young athletes, potentially leading to improved care for these patients in the future.

Gender

ALL

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 (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.