Long-term results of a randomized study on anterior cruciate ligament reconstruction with or without a synthetic degradable augmentation device to support the autograft.

PURPOSE: The aim was to compare the outcome of anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft, with and without a poly(urethane urea) augmentation device.
METHODS: Patients were randomized to BPTB reconstruction with a synthetic degradable augmentation device (n = 96) or without augmentation (n = 105). Follow-ups were made during 4 years after surgical treatment with the KT1000 arthrometer for objective evaluation of sagittal stability. The Tegner scoring system for assessment of physical activity level and the Knee injury Osteoarthritis Outcome Score (KOOS) for assessment of knee-specific health were evaluated after 4 and 12 years.
RESULTS: KT1000 tests showed a significant decrease in mean manual maximum side-to-side difference after 4 years in both patients with and those without augmentation, without any statistical difference between the groups (n.s.). Pre-injury, 76 and 80% of the patients, respectively, reported Tegner level 7-10. Pre-surgery, the corresponding figures were 6 and 5%, and at 4 years, 33 and 30 %. Twelve years after ACL reconstruction, both groups had significantly higher KOOS scores in function in sports and recreational activities (p < 0.001) and knee-related quality of life (p < 0.001) compared to before surgical treatment. In 10 patients, the augmentation device was removed, in six of these because of insufficient screw fixation to femur and in four due to swelling/hydrops.
CONCLUSION: This study showed no significant difference in clinical outcome with use of an additional synthetic augmentation device in a single-bundle BPTB ACL reconstruction compared with non-augmentation, in short, intermediate, or long-term perspective. LEVEL OF EVIDENCE: Therapeutic study, Level I.

RCT Entities:   Population Interventions Outcomes