Mid-Term Performance of the First Mass-Produced Three-Dimensional Printed Cementless Tibia in the United States as Reported in the American Joint Replacement Registry.

ABSTRACT

BACKGROUND: Cementless tibial components have shown improvements in clinical performance compared to predicate designs, though evidence supporting mid-term performance and fixation is scarce. The purpose of this study is to determine the mid-term survivorships, revision rates, and reasons why 3-dimensional printed cementless tibial baseplates (3DTKAs) failed compared to other cementless as well as cemented tibial baseplates reported from the American Joint Replacement Registry (AJRR) data. METHODS: All primary total knee arthroplasty (TKA) cases performed in patients 65 years of age or older within the AJRR from January 2, 2012 through June 30, 2020 were queried. A total of 28,631 3DTKAs were identified from 428 institutions. These were compared to all other "aggregated cementless tibia" (n = 7,577) and "aggregated cemented tibia" (n = 550,133) cases. Centers for Medicare & Medicaid Services data over the same time period were merged with AJRR data to determine survivorship and patient-timed incident revision rates per 1,000 years. Failure reasons were tracked during this study period. RESULTS: At 60 months, Kaplan-Meier implant survivorship was 98.9% (CI 98.7-99.0), 98.3% (CI 97.9-98.6), and 98.4% (CI 98.4-98.5) in the 3DTKA, aggregate cementless, and cemented knee cohorts, respectively (P < .0001). Patient-timed incident revision rates were 3.11 (CI 2.75-3.53), 3.99 (CI 3.34-4.76), and 3.35 (CI 3.28-3.42) for those cohorts, which corresponds to a revision rate of 0.31%, 0.40%, and 0.34% per year. CONCLUSION: In this analysis, 3DTKA had favorable survivorship and lower revision rates compared to aggregate cementless and cemented TKAs implanted from the same national database during the same time period.