Summary
OBJECTIVE: To compare, through a prospective and randomized clinical trial in high-risk patients, combined intra and extra-articular ACLR with ALL using hamstring autograft versus anatomical ACLR using quintuple or sextuple hamstring autograft.
Abstract
Introduction
Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction (ACLR). There are several ways to prepare the graft using these tendons. One can prioritize increasing the diameter of an isolated intra-articular graft folding the grafts 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 in high-risk patients, intra and extra-articular ACLR with ALL using hamstring autograft versus anatomical ACL reconstruction using quintuple or sextuple hamstring autograft.
Methods
146 patients will be randomized into two groups of 73 patients. Group A: Anatomic ACLR(triple semitendinosus and single gracilis) combined with ALL(single gracilis strand). Group B: Isolated Intra-Articular Anatomic ACLR with Quintuple or Sextuple Hamstring Graft Configuration.
INCLUSION CRITERIA: Present ONE OR MORE of the following risk factors for failure- Age for females between 14-25years and for males between 16-25years; Pivot-shift test>2; Chronic ACL injury (>12 months); Athlete (Tegner Scale=7); Tibial slope >12degrees; Recurvatum >5degrees and <15degrees; Generalized ligament laxity (Beighton Scale>5).
NON-INCLUSION CRITERIA: Age>40years;ACL revision;PCLinjury(grade2and3);MCLinjury(grade2and3) or (grade 1 with valgus aligned axis);PLCinjury(grade 2 and 3 Fanelli classification);Recurrent patellar dislocation;Chondral lesion ICRS grade3and4>1cm2;Previous ipsilateral knee surgery;Kellgren-Lawrence grade3or4; Inflammatory disease;Contralateral knee ligament injury;Malalignment >5degrees of clinical asymmetry or symmetric >10degrees varus or valgus;Graft diameter<7mm;BMI>35or< 18;Active malignant neoplasia;Pregnancy;Psychiatric-disorders.
EVALUATION AND OUTCOMES: Patients included in the study will be evaluated preoperatively and after surgery at 3, 6, 9, 12, and 24 months postoperatively. The primary outcomes will be clinical failure rate (persistence of pivot shift grade 1 or higher in more than one postoperative evaluation compared to the contralateral knee, or a grade 2 or higher pivot shift at any postoperative evaluation) and graft rerupture rate (graft tear confirmed by magnetic resonance imaging or arthroscopy in the presence of any clinical failure criteria). Secondary outcomes will include functional capacity assessed through IKDC, Lysholm, KOOS, and Tegner scores, pain using the VAS, as well as stability assessed by digital rolimeter and objective IKDC. Kinesiophobia and anxiety will be measured using the Tampa Scale and Anxiety and Depression scale.
SAMPLE SIZE: 126 individuals (significance-level a of 5%, effect size of 25%, and degree of freedom equal to 1) were calculated for the primary outcome: clinical failure rate and graft rerupture rate. Anticipating a 15% loss of patients during follow-up, 145 patients will be needed to evaluate the graft rupture rate and clinical failure rate as primary outcomes.
STATISTICAL ANALYSIS: The analysis of quantitative variables will be performed with the calculation of mean, standard deviation, and 95% confidence interval for each estimated point. Secondary variables will be analyzed through absolute and relative frequency with a 95% confidence interval calculation. Data will be presented in bar graphs and tables for sample characteristics.
Results
Study started at August, 2022. The ongoing results of the study will be presented at the 2026 ACL Study Group Meeting.