[Protocol for a Randomized Clinical Trial to Assess the Effects of Extra-Articular Strengthening in Anterior Cruciate Ligament Reconstruction on the Clinical and Functional Condition of High-Performance Athletes].

Abstract

Objective: To describe a randomized clinical trial designed to evaluate the impact of three extra-articular reinforcement techniques combined with anterior cruciate ligament reconstruction (ACLR) on postoperative muscle function, activity levels, and return-to-sport in high-performance athletes. The primary hypothesis is that these techniques will differentially influence joint stability and recovery trajectories.

Methods: A prospective, quasirandomized, single-blind trial intending to enroll 220 athletes, between 18 and 45-years-old, with isolated ACL injuries. Participants will be allocated via block randomization to one of three procedures: lateral extra-articular tenodesis (LET), involving fixation of a iliotibial band strip near the anterolateral ligament (ALL) insertion at 30° knee flexion for rotational stability; single-bundle ALL reconstruction (ALL-S), using a gracilis graft between the fibula head and Gerdy's tubercle; and double-bundle ALL (ALL-D), employing two graft limbs in a double tibial tunnel between Gerdy's tubercle and the fibular head, with a single femoral fixation in the anatomical position of the ALL. Assessments will occur preoperatively and at 3, 6, 9, 12, and 24-months postsurgery, including joint laxity, quadriceps morphology, functional performance, and knee isokinetic strength. Furthermore, self-reported outcomes, such as the International Knee Documentation Committee's (IKDC), 36-Item Short Form Health Survey (SF-36), and Tegner scale, will also be collected. Linear mixed-effects models will analyze outcomes, adjusting for meniscal repair status.

Results: Upon completion, this study is expected to identify the most effective extra-articular technique for restoring knee stability and function, potentially guiding surgical decision-making. Our findings may optimize rehabilitation protocols and reduce reinjury rates in athletes.

Conclusion: This protocol describes a comprehensive clinical trial that addresses important gaps in current knowledge regarding optimal surgical approaches for ACLR in athletes.