Histomorphological reaction of bone to different concentrations of phagocytosable particles of high-density polyethylene and Ti-6Al-4V alloy in vivo.

Wear debris has been implicated in the pathogenesis of loosening and osteolysis of total joint replacements by stimulating a foreign body and chronic inflammatory reaction capable of bone resorption. Whether increasing concentrations of wear particles have an adverse biological effect on bone has not been elucidated. We performed a histomorphological and semi-quantitative morphometric analysis of the reaction of bone to different concentrations of phagocytosable particles of high-density polyethylene (HDPE) and titanium 6-aluminium 4-vanadium alloy (Ti-6Al-4V) implanted in the rabbit tibia. The Ti-6Al-4V particles had a diameter of 4.0 +/- 4.4 microns (mean +/- SD); the HDPE particles averaged 4.7 +/- 2.1 microns. Suspensions of 10(6)-10(9) particles per ml were mixed in saline, sterilized, and introduced through a drill hole into the proximal tibia of 30 mature female rabbits. Controls included drilled, but non-implantable limbs. The animals were killed at 16 weeks and histological sections were made of the implant area. Histomorphological assessment was carried out using an interactive image analysis system. The parameters assessed included the presence of histiocytes, foreign body giant cells and inflammatory cells, the location and number of particles, the presence of haematopoeitic elements, fat or necrosis of the marrow, whether healing of the cortical window had taken place, and whether there was evidence of formation or resorption of bone by the periosteum, cortex and marrow. A semi-quantitative rating system was employed. Phagocytosable particles of Ti-6Al-4V and HDPE, in concentrations of 10(6)-10(9) particles per ml, evoked a histiocytic reaction without extensive fibrosis, necrosis or granuloma formation. This reaction occurred without disturbing the normal repair processes of bone formation and resorption to the surgical insult. A clear dose-response effect on the histological parameters assessed in this study was not noted. Using the present model, by 16 weeks, a similar "one time' particle load could be accommodated. The ongoing generation of particulate debris over a more extended period of time might be necessary before the remodelling processes of bone would be disturbed.