Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction

Launched by FEDERAL UNIVERSITY OF SÃO PAULO · Jul 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical approaches for treating torn anterior cruciate ligaments (ACL) in young athletes. The goal is to compare a combined surgery that repairs the ACL and adds extra support to the knee, versus a standard surgery that only focuses on the ACL itself. Researchers want to find out which method leads to fewer re-injuries and better recovery outcomes for patients.

To participate in the trial, patients need to be aged between 14 and 25 years and show certain signs of a chronic ACL injury, such as having a specific knee test result. The study will include 146 patients, who will be randomly assigned to one of the two surgery groups. Participants can expect to be evaluated before their surgery and then again at several points after the surgery over the next two years. This will help track their recovery, pain levels, and overall knee function. It's important to note that some individuals will not be eligible, including those over 40 or with certain knee injuries or health conditions.

Gender

ALL

Eligibility criteria

• • 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.