Status:
ENROLLING_BY_INVITATION
Reconstruction of the ACL With QT Graft With Bone Plug vs BPTB
Lead Sponsor:
Instituto Nacional de Rehabilitacion
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
15-55 years
Phase:
NA
Brief Summary
Background: Anterior cruciate ligament (ACL) injury is one of the most common orthopedic injuries worldwide. Currently, the use of the bone patellar tendon bone graft (BPTB) technique is considered th...
Detailed Description
JUSTIFICATION ACL rupture is one of the most frequent and studied injuries in orthopedic literature. Various short-, medium- and long-term results of ACL reconstruction have been described in the inte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06189573
Start Date
December 18 2023
End Date
December 30 2027
Last Update
May 30 2025
Active Locations (1)
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1
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra
Mexico City, Mexico City, Mexico, 14389