The effect of a plasma-sprayed hydroxylapatite (HA) coating on the degree of bone ingrowth and interface shear attachment strength was investigated using a canine femoral transcortical implant model. Cylindrical implants were fabricated by sintering spherical Co-Cr-Mo particles 500-710 microns in diameter; the nominal implant dimensions were 5.95 +/- 0.05 mm diameter by 18 mm in length. One half of each implant was coated with hydroxylapatite, 25-30 microns in thickness, by a plasma-spray technique. Using strict aseptic technique, the implants were placed through both femoral cortices into defects approximately 0.05 mm undersized. After 2, 4, 6, 8, 12, 18, 26, and 52 weeks, the implants were harvested and subjected to mechanical pullout testing and undecalcified histologic evaluation. The application of the HA coating to porous implants enhanced both the amount of bone ingrowth and the interface attachment strength at all time periods. These differences were statistically significant for the percent of bone ingrowth at the 4-, 6-, 12-, 18-, 26-, and 52-week time periods, and interface shear strength values were significantly different at the 6-, 8-, 12-, 18-, and 26-week time periods. The rate of development of interface strength and bone ingrowth was also more rapid for the HA-coated implants. No evidence of any disruption, mechanical failure, or biologic resorption of the HA coating was observed. The results of the present study--demonstrating a beneficial effect of the HA coating at all time periods--are believed to be due to the use of paired comparisons, which allow assessment of subtle differences that might otherwise have been obscured by normal biological variability.

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The purpose of this study was to evaluate the interface attachment strength and histology of hydroxylapatite (HA) coated and uncoated titanium and cobalt-chromium alloy implants. The canine transcortical plug model was utilized. Four different hydroxylapatite coatings were evaluated. In vitro analysis confirmed that all coatings met FDA guidelines for HA coatings. An unspecified FDA parameter, porosity was found to range from 5-15%. Mechanical testing of the bone-implant interface demonstrated large variation in the performance of the coatings. However, further evaluation of two of the coatings did not demonstrate variations in mechanical characteristics. The histologic findings confirmed the mechanical testing results. The coatings which demonstrated the best mechanical characteristics had excellent bone apposition and uniformity and maintenance of the HA coating at all time periods upon histologic evaluation. Conversely, the coatings which demonstrated inferior mechanical characteristics demonstrated variable amounts of bone apposition and moderate to severe coating degradation and breakup. Cell-mediated osteolysis was observed in regions of severe coating degradation, and particle migration was noted in regions far from the interface. It was hoped that the four coatings would behave similarly as they all met current FDA guidelines. The only parameter which differed significantly among the coatings was coating porosity. Our results indicate that coatings with large porosities were associated with increased coating degradation and poor mechanical performance and osteolysis at the bone-coating interface.

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