| Abstract: | ![]()
A thermoplastic polymer, Delrin 150 (polyoxymethylene homopolymer), with creep resistance ten times that of ultrahigh-molecular-weight polyethylene, is used as a material for total joint prostheses. A study was made of the local and systemic host response to this polymer when implanted in three different mammalian species. 316 LC stainless steel was used as a control. The materials were implanted into muscle and bone as solid cylinders. A total of 446 samples were implanted into 74 animals. The duration of implantation ranged from 2 weeks to 2 years. A semi-quantitative evaluation of local tissue reaction was performed. For each implant, 16 histological criteria were graded for severity of host tissue reaction. The liver, spleen, kidneys, pancreas, and lungs from each animal were also studied for evidence of systemic toxicity. The polymer implants exhibited a mild tissue reaction with the same characteristics as the control. Local tumor formation, bone osteolysis, and surrounding muscle necrosis were not seen. No pathological changes compatible with systemic toxicity by Delrin 150 were observed in the study of the organs. Delrin 150 in solid form did not exhibit local or systemic toxicity and is therefore biocompatible by this study. Powder implantation studies should be performed to simulate tissue response to wear particles. |
