Abstract
BACKGROUND: It is unclear whether there is a clinical benefit to adding hydroxyapatite (HA) coatings to total knee implants, especially with the tibial component, where failure of the implant more often occurs. A systematic review of the literature was undertaken to identify all prospective randomized trials for determining whether the overall clinical results (as a function of durability, function, and adverse events) favored HA-coated tibial components. METHODS: A comprehensive literature search was performed for the years 1990 to September 16, 2010. We restricted our search to randomized controlled trials involving participants receiving either an HA-coated tibia or other forms of tibial fixation. The primary outcome measures evaluated were durability, function, and acute adverse events. RESULTS: Data from 926 evaluable primary total knee implants in 14 studies were analyzed. Using an RSA definition for durability, HA-coated tibial components (porous or press-fit) without screw fixation were less likely to be unstable at 2 years than porous and cemented metal-backed tibial components (RR = 0.58, 95% CI: 0.34-0.98; p = 0.04, I(2) = 39%, M-H random effects model). There was no significant difference in durability, as measured from revision and evaluated at 2 and 8-10 years, between groups. Also, functional status using different validated measures showed no significant difference at 2 and 5 years, no matter what measure was used. Lastly, there was no significant difference in adverse events. Limitations included small numbers of evaluable patients (≤ 50) in 7 of the 14 trials identified, and a lack of "hard" evidence of durability with need for replacement (i.e. frank failure, pain, or loss of functionality). INTERPRETATION: In patients > 65 years of age, an HA-coated tibial implant may provide better durability than other forms of tibial fixation. Larger trials should be undertaken comparing the long-term durability, function, and adverse events of HA-coated implants with those of other porous-coated tibial implants in younger, more active OA patients.