Background: A large skull defect may occur after different events such as trauma, tumor resection, and vascular injuries. There is still some doubt about the best material to use for reconstruction. Hydroxyapatite ceramic is one of the materials in use, and its biocompatibility and osteoconductivity are well established. This study evaluated the interaction of a commercial hydroxyapatite custom-made prosthesis implanted in a large skull defect, to assess its osteointegration and its habitability with newly formed bone over time. Methods: Ten sheep underwent craniectomy and reconstruction of the skull defect with a porous hydroxyapatite cranial prosthesis. The animals were divided into two groups: animals in group A were euthanized after 6 months and animals in group B were euthanized after 12 months. At the end of the experimental periods, each implant was evaluated macroscopically and radiologically, and analyzed by micro-computed tomography, histology, histomorphometry, and microhardness techniques. Results: During the study, no adverse events occurred, and there was no evidence of inflammation or negative tissue reactions. Histology and histomorphometry showed new bone formation inside the implant in both experimental periods; newly formed bone had increased significantly (p <0.05) by over 300 percent between 6 and 12 months. Three-dimensional micro-computed tomographic analysis showed new bone formation and material remodeling. Microhardness analysis indicated that the mineralization process and the mechanical properties of newly formed bone were not altered. Conclusions: The hydroxyapatite prosthesis showed its osteoconductivity and good biocompatibility. A low rate of fibrous tissue formation and a high rate of bony regeneration were found.
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