Biocompatibility of materials for total joint replacement.

The clinical use of total joint prostheses demands absolute biocompatibility of the materials employed. The purpose of this experiment was the bioassay of some materials considered as possible candidates for use in total joint prostheses as load-bearing members or as wear-resistant surfaces. Some materials already in use were also tested. 316L stainless steel was used as a control. The materials were implanted as a standardized rod and in particulate form. An average of 12 samples per material were implanted in soft tissue for six months and a total of 145 rabbits were used in this study. Twenty-five materials including metals, polymers, and ceramics were tested in solid and powdered form. A semiquantitative evaluation of local tissue reaction and a study of organs was performed. Polymers and metallic materials showed in general a mild tissue reaction. Ceramics, which some authors describe as the best tolerated materials, elicited variable tissue responses. Some of these (glass-ceramics) presented very poor tissue tolerance. The least reactive, titanium oxide, titanium aluminate, and aluminum oxide, presented a degree of tissue reaction comparable to that of corrosion resistant metals, but not superior to them. Moderate reactivity was the general rule for particulate materials except for the Pyroceram glass-ceramics, polymides, and Teflon. Ultrahigh molecular weight polyethylene in particulate form elicited a rather cellular tissue response, a fact to be considered when projecting long-term results in total joint arthroplasty. No pathological changes compatible with systemic toxicity by materials tested were observed in the study of the organs.