An evaluation of variables influencing implant fixation by direct bone apposition.

A systematic mechanical and histologic evaluation of design variables affecting bone apposition to various biocompatible materials was undertaken. The variables investigated included material elastic modulus, material surface texture, as well as material surface composition. The implant materials included polymethylmethacrylate (PMMA), low-temperature isotropic (LTI) pyrolytic carbon, commercially pure (C.P.) titanium, and aluminum oxide (Al2O3). Implant surface texture was varied by either polishing or grit-blasting the various materials. Implant surface composition was varied by applying a coating of ultra-low temperature isotropic (ULTI) pyrolytic carbon to the various implants. A total of 12 types of implants were evaluated in vivo by placement transcortically in the femora of adult mongrel dogs for a period of 32 weeks. Following sacrifice, mechanical push-out testing was performed to determine interface shear strength and interface shear stiffness. The results obtained from mechanical testing indicate that for implants fixed by direct bone apposition, interface stiffness and interface shear strength are not significantly affected by either implant elastic modulus or implant surface composition. Varying surface texture, however, significantly affected the interface response to the implants. For each elastic modulus group the roughened surfaced implants exhibited greater strengths than the corresponding smooth surfaced implants. Undecalcified histologic evaluation of the implants demonstrated that the roughened implants exhibited direct bone apposition, whereas the smooth implants exhibited various degrees of fibrous tissue encasement. Thus, for implants utilizing direct bone apposition fixation, it appears that of the parameters investigated, implant surface texture is the most significant.