Anterior Cruciate Ligament Reconstruction Using Autologous Hamstrings Augmented with Ligament Augmentation and Reconstruction Systems (LARS) or Synthetic Meshwork of LARS Compared with Four-Strand Hamstring Tendon Grafts Alone, a Prospective, Randomized Clinical Study with 2- to 8-Year Follow-Up.

PURPOSE: To compare the long-term outcomes of anterior cruciate ligament (ACL) reconstruction using a four-strand hamstring tendon graft alone (hamstring group) or with synthetics (Ligament Augmentation and Reconstruction System, LARS group) or synthetic meshwork of LARS (meshwork group).

METHODS: Patients who underwent ACL reconstruction using four-strand hamstring tendon grafts (hamstring group), autologous hamstrings augmented with the LARS (LARS group), or synthetic meshwork of LARS (meshwork group) were selected in this prospective randomized clinical study. Patient-reported outcome measures (PROMs) were obtained preoperatively; at 6, 12, and 18 months postoperatively; and at final follow-up between 3 and 8 years. Second-look arthroscopic findings were used to evaluate graft morphology based on graft tension, graft tear, and synovial coverage.

RESULTS: A total of 141 consecutive patients underwent ACL reconstruction, 47 patients in each group, and 21 patients were lost to follow-up during the study period. At the 6-month follow-up, the IKDC scores and Lysholm scores were significantly better in the LARS group ( P  < 0.05). At the 6- and 12-month follow-ups, the KOS-ADLS, KOOS-activities of daily living and quality of life, NSARS scores, GRC scores, Tegner scores, and ACL-RSI scores were significantly better in the LARS group ( P  < 0.05). For the LARS group, hamstring group, and meshwork group, the cumulative failure rates were 8.5%, 12.8%, and 4.3%, respectively. Malposition of the femoral tunnel was significantly associated with cumulative failure ( P  < 0.05). There was no difference between the groups in other outcomes at any other time, including radiographic and arthroscopic outcomes.

CONCLUSIONS: ACL reconstruction using autologous hamstring augmented with LARS resulted in significantly better clinical scores with a faster return to sports and comparative side-to-side differences in graft laxity by 6 and 12 months follow-up. Despite these findings, no statistically significant differences were seen among the three patient groups in terms of objective outcomes and clinical scores at the 18-month, 3-year and 8-year follow-ups. Additionally, a malpositioned femoral tunnel was associated with graft failure.