Comparing two methods of ACL reconstruction
Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction: Prospective Multicenter Randomized Clinical Trial With Hamstring Autograft
This study tests if adding a specific ligament repair during ACL surgery can help young people avoid re-injury better than the usual surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 14 Years to 40 Years |
| Sex | All |
| Sponsor | Federal University of São Paulo Academic / other |
| Locations | 2 sites (São Paulo, São Paulo and 1 other locations) |
| Trial ID | NCT06505525 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of combined intra- and extra-articular ACL reconstruction with anterolateral ligament (ALL) reinforcement against isolated intra-articular ACL reconstruction using hamstring autografts. A total of 146 patients aged 14 to 25 will be randomly assigned to one of the two surgical approaches. Participants will be evaluated preoperatively and at multiple intervals post-surgery to assess clinical outcomes and failure rates. The study seeks to determine if the addition of ALL reconstruction can reduce re-injury rates compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are athletes aged 14 to 25 with chronic ACL injuries and specific risk factors.
Not a fit: Patients over 40 years of age or those with significant knee injuries or previous surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to lower re-injury rates and improved outcomes for young athletes with ACL injuries.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo and 1 other locations
- Sao Paulo Hospital — São Paulo, São Paulo, Brazil (Recruiting)
- Parelheiros Hospital — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Marcos Vinicius Credidio — Federal University of São Paulo
- Study coordinator: Marcos Vinicius Credidio
- Email: mvcredidio@gmail.com
- Phone: 11980629367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.