Status:
RECRUITING
Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction
Lead Sponsor:
Federal University of São Paulo
Conditions:
Anterior Cruciate Ligament Rupture
Ligament Knee Injury
Eligibility:
All Genders
14-40 years
Phase:
NA
Brief Summary
Abstract Introduction: Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction worldwide. There are several ways to prepare the graft using these tendons. One can priorit...
Detailed Description
1. Introduction Arthroscopic reconstruction of the anterior cruciate ligament (ACL) is a well-established procedure known for its superiority over non-surgical treatment of this injury. However, failu...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients from the hospital's demand (emergency care and outpatient care) and from CROSS (Center for Regulation of Health Service Offers) who present one or more risk factors will be included:
- Age (Female 14 years - 25 years and Male 16 years - 25 years);
- Pivot-shift test \> 2;
- Chronic ACL injury (\>12 months);
- Athlete (Tegner Scale ≥ 7);
- Tibial slope \> 12 degrees;
- Recurvatum \> 5 degrees and \< 15 degrees (asymmetric);
- Ligamentous Hypermobility (Beighton Scale \> 5).
- Non-Inclusion Criteria
- Individuals over 40 years of age will not be included;
- ACL revision;
- PCL injury (grade 2 and 3);
- MCL injury (grade 2 and 3) or (grade 1 with valgus aligned axis);
- CPL injury (grade 2 and 3 according to Fanelli classification);
- Recurrent patellar dislocation;
- Severe chondral lesion (ICRS grade 3 and 4) larger than 1cm2;
- Previous ipsilateral knee surgery;
- Kellgren Lawrence grade 3 or more;
- Autoimmune/rheumatologic inflammatory disease;
- Contralateral knee ligament injury;
- Malalignment \> 5 degrees clinical asymmetry between limbs or symmetric \> 10 degrees axis deviation to varus (corresponding to \> 4 degrees varus between the anatomical axis of the femur and the anatomical axis of the tibia in the clinical examination) or \> 10 degrees axis deviation to valgus (corresponding to \> 16 degrees valgus between the anatomical axis of the femur and the anatomical axis of the tibia in the clinical examination);
- Graft diameter \< 7 mm;
- BMI \> 35 or \< 18;
- Active or undergoing treatment for malignant neoplasia;
- Pregnancy or suspected pregnancy;
- Psychiatric disorders.
- Exclusion Criteria
- Leave of absence from work due to disability or reduced income assistance (worker's compensation) whenever one of the investigators considers that the participant may be simulating a worse health condition than reality in order to receive financial assistance with work leave.
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06505525
Start Date
August 1 2022
End Date
June 1 2027
Last Update
April 3 2025
Active Locations (2)
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1
Sao Paulo Hospital
São Paulo, São Paulo, Brazil, 04024-002
2
Parelheiros Hospital
São Paulo, São Paulo, Brazil, 04883-290