Tissue response to in situ polymerization of a new two-solution bone cement: Evaluation in a sheep model

A two-solution bone cement (2-SC) was evaluated in a non-load bearing sheep model that simulated insertion of a cemented total joint replacement. A commercial powder–liquid bone cement formulation (Palacos® R) was used as the control. The systemic response to the two cements was determined by monitoring changes in arterial blood pressure (ABP) and serum concentrations of methyl methacrylate monomer at intervals after insertion of the cement. The short-term tissue response to the two cements was assessed by quantifying histomorphometric parameters of new bone formation at 2, 4, and 12 weeks postsurgery. Intraoperatively, injection and pressurization of bone cement were well tolerated, with no significant changes in ABP in either group and no detectable circulating monomer in any animal. Several interesting trends were identified in the histomorphometry data. In the trabecular specimens, new bone formation immediately adjacent to the cement mantle was apparently suppressed in the first 2 weeks postsurgery, increased dramatically at 4 weeks, and then returned to baseline values by 12 weeks. This pattern was seen with both Palacos® and 2-SC. In the cortical specimens, new bone formation was reduced on the endosteal surface when compared with the periosteal surface, with this effect being more noticeable at 2 and 4 weeks than at 12 weeks. There were no significant histopathological findings in either the bone or the draining lymph nodes. These data indicate that the biological response to 2-SC is substantially equivalent to that of Palacos® R. Additional testing in a functional, load-bearing animal model is now recommended to more fully characterize the long-term biological response to 2-SC and to determine the mechanical performance of this new cement in vivo. © 2006 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2006