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

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. 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. 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. 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.