The efficacy of custom-made porous hydroxyapatite prostheses for cranioplasty: Evaluation of postmarketing data on 2697 patients

Purpose: Cranioplasty is a surgical intervention aimed at reestablishing the integrity of skull defects. Autologous bone is still considered the treatment of choice for cranioplasty. The aims of this study were to characterize and evaluate the efficacy of porous hydroxyapatite (HA) to fill skull defects based on its biomimetic characteristics. Methods: The authors analyzed the postmarketing data of all patients treated with custom-made porous HA prostheses (CustomBone Service). Characterization data in terms of physicochemical analysis and mechanical performance of the porous HA prostheses were also reported. Results: The low incidence of adverse events (5.72%) due to the use of HA porous custom-made prostheses for cranioplasty is related to the biomimetic performance of the prostheses. The composition and morphology of the porosity enable it to be a useful biomimetic prosthesis for the reconstruction of large and complex skull defects, also able to promote osteointegration. Conclusions: These collected and analyzed data demonstrate that porous HA is a suitable material to produce custom-made prostheses to repair craniolacunia. It is a biomimetic implant well-tolerated in both adult and pediatric patients and has been shown to be an effective and good alternative for cranial reconstruction.