Use of "custom made" porous hydroxyapatite implants for cranioplasty: postoperative analysis of complications in 1549 patients.

Background: Cranioplasty is a surgical intervention aimed at reestablishing the integrity of skull defects, and should be considered the conclusion of a surgical act that began with bone flap removal. Autologous bone is still considered the treatment of choice for cranioplasty. An alternative choice is bioceramic porous hydroxyapatite (HA) as it is one of the materials that meets and comes closest to the biomimetic characteristics of bone. Methods: The authors analyzed the clinical charts, compiled by the neurosurgeon, of all patients treated with custom‑made porous HA devices (Custom Bone Service Fin‑Ceramica, Faenza) from which epidemiological and pathological data as well as material‑related complications were extrapolated. Results: From November 1997 to December 2010, 1549 patients underwent cranioplasty with the implantation of 1608 custom‑made porous HA devices. HA was used in 53.8% of patients for decompressive craniectomy after trauma or intracranial hemorrhage, while the remaining cases were for treated for comminuted fracture, cutaneous or osseous resection, cranial malformation, autologous bone reabsorption or infection or rejection of previously implanted material. The incidence of adverse events in patients treated for cranioplasty, as first line treatment was 4.78% (56 events/1171 patients), and 5.02%, (19 events/378 patients) at second line. Conclusion: This study demonstrates that HA is a safe and effective material, is well tolerated in both adult and pediatric patients, and meets the requirements necessary to repair craniolacunia.