John N. Insall Award: Randomized Clinical Trial of Cementless Versus Cemented Tibial Components: Durable and Reliable at a Mean 10-Years Follow-Up.

BACKGROUND: Cementless fixation is gaining popularity for primary total knee arthroplasties (TKAs). The prior 5-year results of our randomized clinical trial that included 3 different tibial designs found minimal differences. The purpose of the current study was to investigate the 10-year results in the same cohort.

METHODS: Between 2003 and 2006, 389 primary TKAs were randomized: traditional modular cemented tibia (135); hybrid (cemented baseplate with uncemented pegs) monoblock tibia (128); and cementless monoblock tibia (126). Implant survivorships, radiographs, and clinical outcomes were analyzed. Mean age at TKA was 68 years (range, 41 to 85), 46% were male, and mean body mass index was 32 (range, 21 to 59). The mean follow-up was 10 years.

RESULTS: The 10-year survivorship free of any revision was similar between the hybrid monoblock and cementless monoblock groups at 96%, but lower (89%) for the traditional modular cemented tibia (P = .05). The traditional modular cemented tibia group had significantly more revisions for aseptic tibial loosening than the other 2 groups (7 versus 0%) at 10 years (P = .003). The traditional modular cemented tibia group had significantly more nonprogressive radiolucent lines than the hybrid and cementless monoblock groups (24, 12, and 9%, respectively). Clinical outcomes were similar and excellent between all 3 groups.

CONCLUSION: Cementless and hybrid monoblock tibial components have excellent implant survivorship (96%) with no cases of aseptic tibial loosening to date. The traditional cemented modular tibial group had a 7% cumulative incidence of aseptic loosening at 10 years.

LEVEL OF EVIDENCE: Level I, Prospective Randomized Control Trial.