Ligament Advanced Reinforcement System (LARS) synthetic graft for complex ligament reconstruction after chronic elbow instability: a randomized controlled trial.

研究概要

193 patients with complex chronic elbow instability were randomized to receive ligament reconstruction using a Ligament Advanced Reinforcement System (LARS) synthetic graft or autologous palmaris longus tendon graft reconstruction using the box-loop technique. The primary outcome of interest was the American Shoulder and Elbow Surgeons (ASES) Elbow Function Subscore at 24 weeks. Secondary outcomes included ASES pain subscores, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, elbow range of motion, flexion strength, EQ-5D-5L quality-of-life measures, adverse events, and cost-effectiveness outcomes. Outcomes were assessed preoperatively and at 4, 12, and 24 weeks postsurgery. Overall, the results of the study revealed that the LARS group demonstrated significantly greater improvements in elbow function, pain relief, and flexion strength compared to the autograft group, particularly during the early postoperative recovery period. Although total costs were higher with LARS reconstruction, the synthetic graft reduced donor-site morbidity and demonstrated acceptable safety outcomes. These findings suggest that LARS reconstruction may represent an effective alternative to autologous graft reconstruction for complex chronic elbow instability.