RESUMO
PURPOSE: Button implants with an adjustable-loop device (ALD) are often used in anterior cruciate ligament reconstruction (ACLR). Clinical research comparing ALDs with fixed-loop devices (FLD) has mainly been conducted in small patient populations with short follow-up times. To determine whether ALDs are safe to use in ACLR, a non-inferiority study with a large sample population and a long follow-up period would be beneficial. This study compared ALDs with FLDs to determine non-inferior revision surgery rates, knee stability, and patient-reported outcomes (PROM) in ACLRs. METHODS: This non-inferiority register-based cohort study was conducted using data from the Danish Knee Ligament Reconstruction Registry (DKRR). A total of 12,723 patients > 15 years of age with primary ACLR using hamstring tendon autografts and either an FLD or ALD for femoral fixation were included: 9719 patients were in the FLD group, and 3014 patients were in the ALD group. The primary outcome was revision ACLR with a non-inferiority margin for ALDs at 4% at the 2-year follow-up. The secondary outcomes were anterior and rotatory knee stability and PROMs based on the Knee Injury and Osteoarthritis Outcome Score (KOOS) at the 1-year follow-up. RESULTS: The crude cumulative revision rates in ALD implants at 2 and 5 years were 2.1% (95% CI 1.62-2.68) and 5.0% (95% CI 4.22-5.96), respectively. In the FLD group, the rates were 2.2% (95% CI 1.89-2.48) at 2 years and 4.7% (95% CI 4.31-5.20) at 5 years. The 1-year side-to-side differences were 0.97 mm (95% CI 0.90-1.03) in the ALD group and 1.45 mm (95% CI 1.41-1.49) in the FLD group. In the FLD group, 13% had a positive pivot shift, and in the ALD group, 6% had a positive pivot shift. There were no differences in KOOS. CONCLUSION: ALDs were non-inferior to FLDs regarding revision rates, knee stability, and patient-reported outcomes. Based on this conclusion, ALDs are safe to use for femoral fixation in ACLR. LEVEL OF EVIDENCE: III.