Preparation and characterization of wear debris of orthopedic materials for biocompatibility studies.

In order to test the biocompatibility of wear debris of orthopedic materials, a method has been developed to produce artificial debris of stainless steel, cobalt-chromium alloy, and high-density polyethylene. In this process, called the accelerated rubbing process, two cylindrical blocks of the same alloy were held under normal pressure in triply distilled water. One block remained stationary while the other rotated at approximately 4000 rpm. The water with the metal debris was recirculated between the rubbing surfaces. To prepare debris from polyethylene, a stainless steel block was rubbed over a polyethylene block submersed in liquid nitrogen. The shape of the metal debris was granular, whereas the polyethylene debris had a shred-like shape. The size distributions were determined from scanning electron micrographs, and it was found that the particles of the metal debris (stainless steel or cobalt-chrome alloy) ranged in sizes from 0.1-10 mu with 75% of all particles less than 2 mu in diameter. The size of polyethylene debris, expressed as the volume of an ellipsoid, ranged from 10-20,000 mu3 with 45% of all particles in the range of 400-2500 mu3. The x-ray diffraction pattern revealed that the debris of stainless steel consisted primarily of the face-centered cubic (fcc) alloy with small amounts of body-centered cubic (bcc) alloy and Fe3O4, whereas the cobalt-chrome debris consisted of the fcc alloy with a small amount of Cr2O3. The structure of the polyethylene debris was quite similar to that of the solid sample used in its preparation. The percent crystallinity Pc and the size of the crystalline regions D were slightly smaller in the debris than in the solid sample, i.e., Pc = 52 and 55%, D = 90 and 130 A, in the debris and the solid, respectively. To test the suitability of the artificial debris for biocompatibility studies, stainless steel debris was implanted into knees of adult female New Zealand rabbits. Bacterial challenge studies indicated prolongation, but not increased susceptibility to infection.