All-inside versus transtibial technique in anterior cruciate ligament reconstruction: a randomized controlled clinical trial

Abstract

Background: Anterior cruciate ligament (ACL) tear is one of the most frequent injuries of sports medicine. Surgical reconstruction remains the most used treatment after an ACL tear grade III. An emerging procedure, the all-inside technique, was reported to have less postoperative pain comparing to the conventional and most used transtibial procedure. Nonetheless, low evidence is available and functional results (such as range of motion or ligament laxity) obtained after both techniques have not been assessed. Hypothesis and objectives: All-inside technique will present better functional results (expressed as range of motion) than the conventional transtibial technique, in patients aged 18-50 years old undergoing ACL reconstruction. The aim of this study is to evaluate the functional results obtained after two different techniques of ACL reconstruction, all-inside and transtibial procedures. We will also collect other data and compare the pain, the subjective knee’s functionality and report postoperative complications of patients during two years. Design and setting: A randomized, single-blind, controlled clinical trial will be carried out in Hospital Universitari Dr. Josep Trueta, in Girona, within the Orthopaedics and Trauma Surgery Department from March 2017 until September 2023. Participants: Men and women aged 18-50 years old, with a diagnosed ACL injury grade III, produced at least 21 days before the surgery, without concomitant ligament injuries, chondral debridement or documented osteoarthritis in ipsilateral knee. Methods: A non-probabilistic, consecutive method of recruitment will be used. 148 patients with an ACL tear grade III will be randomly assigned, in a 1:1 ratio, to one of the treatment groups, either all-inside technique or transtibial one. Patients will be assessed during two years after the surgery, evaluating range of motion (total range, flexion and extension), ligament laxity (KT-1000 arthrometer), pain (Visual Analogue Scale) and knee’s functionality (IKDC and Lysholm scores). We will also report any complication that may be developed. T-student’s test will be used for the statistical analysis of the mean range of motion obtained after both techniques. A confidence interval of 95% will be assumed and p<0.05 will be considered statistically significant