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< Vol. 13 Issue 2 | Apr-Jun 2015 | pp. e73 - e193

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

Abstract

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.

J Appl Biomater Funct Mater 2015; 13(2): e136 - e144

Article Type: ORIGINAL RESEARCH ARTICLE

DOI:10.5301/jabfm.5000211

Authors

Roberto Stefini, Bruno Zanotti, Angelo Nataloni, Roberta Martinetti, Michele Scafuto, Marco Colasurdo, Anna Tampieri

Article History

  • • Accepted on 24/01/2014
  • • Available online on 19/12/2014
  • • Published online on 04/07/2015

Disclosures

Informed consent: Postmarketing clinical data were treated in compliance with D.Lgs. n.196/2003.
Financial support: None.
Conflict of interest: None.

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Authors

Affiliations

  • Department of Neurosurgery, University of Brescia, Spedali Civili, Brescia - Italy
  • Department of Neurosurgery, S. Maria della Misericordia Hospital, Udine - Italy
  • Fin-Ceramica Faenza S.p.A., Faenza, Ravenna - Italy
  • ISTEC – CNR, Faenza, Ravenna - Italy

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