关节外加强技术联合前交叉韧带重建对高水平运动员临床与功能状态影响的随机临床试验方案
简介
本研究是一项前瞻性、半随机、单盲临床试验，旨在评估前交叉韧带重建（ACLR）联合三种关节外加强技术对高水平运动员术后肌肉功能、活动水平及重返运动的影响。计划纳入220名18–45岁单纯ACL损伤运动员，随机分为三组：外侧关节外肌腱固定术（LET，髂胫束条固定于前外侧韧带（ALL）附近）、单束ALL重建（ALL-S，股薄肌移植物连接股骨外上髁与Gerdy结节）…
英文摘要
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) at 30° knee flexion for rotational stability; single-bundle ALL reconstruction (ALL-S), using a gracilis graft between the femoral epicondyle and Gerdy's tubercle; and double-bundle ALL (ALL-D), employing two graft limbs in a double tibial tunnel located between Gerdy's tubercle and the fibular head, with a single femoral fixation at 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.