Reconstruction of the ACL With QT Graft With Bone Plug vs BPTB
Launched by INSTITUTO NACIONAL DE REHABILITACION · Dec 18, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This clinical trial is investigating two different methods for repairing a torn anterior cruciate ligament (ACL), which is a common injury, especially among athletes. The trial compares the traditional bone-patellar tendon-bone (BPTB) graft technique with a newer option called the quadriceps tendon (QT) graft. Researchers want to see which method provides better results in terms of knee function and if there are any complications after surgery.
To participate in this study, you need to be between 15 and 55 years old and have a confirmed ACL tear diagnosed by an MRI. Certain health conditions, like diabetes or previous knee surgeries, might disqualify you from joining. If you do take part, you'll undergo surgery where you'll be randomly assigned to one of the two graft types. Over the next two years, your knee will be evaluated at regular intervals to measure its stability and your recovery. This trial is an opportunity to help improve ACL repair techniques, benefiting future patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Men and women from 15 to 55 years old.
- • Primary ACL rupture diagnosed by MRI.
- • INR-LGII patients with a complete institutional record.
- • Without the presence of systemic, chronic degenerative comorbidities that could affect the quality of the graft. (Diabetes, Thyroid, Autoimmune diseases).
- Exclusion Criteria:
- • Grade 2 or 3 posterior cruciate ligament injuries.
- • Multiligamentous injuries.
- • Severe varus/valgus deformities (mechanical axis outside the range of 35% to 65% of the articular surface of the tibia).
- • Previous knee surgeries to be treated.
- • Anterior knee pain present (VAS greater than 6), with brush and escape maneuvers positive.
- • K\&L osteoarthritis ≥ 2 in the knee to be treated.
- • History of intra-articular fractures of the injured knee.
- • History of ACL injury and/or surgery in the contralateral knee.
- • Previous injury to the patellar or quadriceps tendon (total or partial rupture).
- • Symptomatic extensor mechanism tendinopathies.
- • High patella (Caton-Deschamps index 1.2 mm)
- • ICRS grade III or IV chondral lesion in patella greater than 1cm 2
- • Medical conditions that prevent full patient participation (e.g. cancer active, rheumatoid arthritis, etc.)
- • Pregnancy.
- • Obesity (WCC \>30).
- Perioperative elimination criteria:
- • Medial or lateral meniscus injury \>50% non-repairable.
- • Medial and/or lateral menisectomy \> 50%
- • Grade 2-3 ligament instability associated with ACL injury.
- • Cartilage lesion \>2 cm2 ICRS grade 3-4, untreated.
- • Associated surgeries due to instability.
About Instituto Nacional De Rehabilitacion
The Instituto Nacional de Rehabilitación (INR) is a leading clinical research organization dedicated to advancing rehabilitation science and improving patient outcomes. As a prominent sponsor of clinical trials, INR focuses on innovative therapeutic interventions and comprehensive rehabilitation strategies for individuals with disabilities and chronic conditions. With a commitment to excellence in research methodology and ethical standards, INR collaborates with multidisciplinary teams to conduct rigorous studies that contribute to evidence-based practices in rehabilitation medicine. Through its initiatives, the institute aims to enhance the quality of life for patients while fostering the development of new treatments and technologies in the field.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Mexico City, , Mexico
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported