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

RecruitingNAAges 14 Years - 40 YearsAllFederal University of São Paulo
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In plain words

What the trial is, and whether it could suit you

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 prioritize increasing the diameter of an isolated intra-articular graft or alternatively, using one graft limb as an extra-articular reinforcement via the anterolateral ligament (ALL) reconstruction, with both options aiming to reduce the re-rupture rate relative to traditional quadrupled hamstring grafts. Objective: To compare, through a prospective and randomized clinical trial, intra and extra-articular ACL reconstruction with ALL using hamstring autograft versus isolated anatomical ACL reconstruction using quintuple or sextuple hamstring autograft. Methods: 146 patients will be randomized into two groups of 73 patients. Patients included in the study will be evaluated preoperatively and after

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📋 Eligibility rules (as published)
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.
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What it tests

  • Extra-articular reconstruction with the Anterolateral Ligament
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Where

2 sites
Sao Paulo Hospital
São Paulo, Brazil
Parelheiros Hospital
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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