Bone healing response to an injectable calcium phosphate cement with enhanced radiopacity

The aim of this study was to determine the impact of barium sulfate on remodeling and regeneration in standard tibial defects in rabbits treated with the Norian skeletal repair system (SRS). Two formulations of SRS (with and without barium sulfate) were injected into the medullary canal of the tibia of New Zealand white rabbits. Animals were sacrificed at 6 weeks, 6 months, 1 year, and 2 years. Over the 2-year duration of the study, standard SRS and SRS with barium sulfate appeared to be biocompatible and osteoconductive with no evidence of either inflammation or fibrous tissue around the implant materials or at the bone-material interfaces. This outcome underscores the osteophilic property of the SRS. A difference we observed between the standard SRS and the SRS with barium sulfate was the appearance of acellular material contiguous to the SRS with barium sulfate. Energy dispersive X-ray spectroscopy (EDX) analysis was conducted and confirmed that the acellular material was barium sulfate. Pathological examination of additional tissues including regional lymph nodes revealed neither dissemination of calcium phosphate nor barium sulfate. We concluded that the residual barium sulfate detected by EDX was localized to the intramedullary canal of the tibia.