The ultrastructural architecture of the tissue/hard-tissue replacement interface.

This investigation examined the tissue response and interfacial bonding between bone and hard-tissue replacement (HTR) using scanning (SEM) and transmission (TEM) electron microscopy. Twenty adult male Sprague-Dawley rats were anesthetized and a hole (1.0 mm deep by 2.0 mm wide) was drilled in the calvarium. Subsequently, HTR was implanted and the wound closed. The implants and surrounding tissues were removed at 7, 14, 28, and 56 days and prepared for examination by SEM or TEM. Scanning electron microscopic analysis revealed a typical inflammatory response that subsided by day 14. At that time, a fine layer of collagen fibrils (fibrous envelope) was observed covering the polymeric surface. Energy dispersive x-ray analysis (EDXA) showed no sign of mineralization. Ultrastructural analysis demonstrated that the fibrous envelope was bilaminar; it consisted of a relatively undifferentiated cellular layer adjacent to the polymer and an outer fibrous region. Scanning electron microscopic analysis of 28-day implants showed that osteoblasts had migrated onto the outer surface of the fibrous envelope and that calcification had been initiated as judged by EDXA. Electron microscopic examination confirmed previous observations of an undifferentiated cellular layer along the interfacial boundary, but also showed both macrophages and foreign-body giant cells. At 56 days, bone was observed to contact and cover the fibrous envelope surrounding the polymeric bead; however, EDXA showed that the fibrous envelope remained noncalcified. Transmission electron microscopic analysis revealed that the inner cellular layer was beginning to mature, as indicated by the presence of numerous cellular organelles. This maturation was accompanied by an increased incidence of macrophages as well as foreign-body giant cells. Within the time constraints of the experimental design, it is apparent that a bilaminar layer of cells and fibers remains between the HTR and the bone. Additional studies will be necessary, over extended time periods, to determine whether the bilaminar layer remains a constant feature between the HTR and the surrounding bone or whether this region is gradually supplanted by the ingrowing bone.