Isolation and characterization of debris in membranes around total joint prostheses.

Particles of wear debris have been implicated in osteolysis around and aseptic loosening of total joint prostheses, but the number and size distribution of particles present in periprosthetic tissues are unknown. A method of particle assay was developed, consisting of nitric-acid digestion of tissue followed by collection of particles, electronic quantitation, and parallel morphological and chemical characterization. Nitric acid had minimum deleterious effects on control samples of titanium, cobalt-chromium alloy, and polyethylene particles, as determined by atomic absorption spectroscopy, scanning electron microscopy, and electronic measurements of the sizes of the particles. Acid digestion of twelve control samples of tissue, including tissue rich in hemosiderin, resulted in particle counts that were no higher than that in the digestion solution background. Other digestion preparations, including hydrochloric acid and sodium hypophosphate, were not as effective as nitric acid. With the low size limit of detection of approximately 0.58 micrometer, particle analysis of tissue adjacent to twenty retrieved total joint implants indicated a range of concentration of 0.85 to 141.85 x 10(9) particles per gram of tissue (dry weight). Although a few particles of more than 100 micrometers were detected, the mode of particle diameter from each sample ranged from the lower limit of detection (approximately 0.58 micrometer) to 0.79 micrometer. The findings of morphological studies and x-ray spectroscopy of isolated particles corresponded with those of light microscopy of the fibrous membranes. These data indicate that most of the particles in implant membranes are smaller than the resolution of the light microscope and that tissue digestion is necessary for quantitation and characterization.