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Custom-made hydroxyapatite for cranial repair in a specific pediatric age group (7–13 years old): a multicenter post-marketing surveillance study

  • Paolo Frassanito
  • Luca Massimi
  • Gianpiero Tamburrini
  • Federico Bianchi
  • Angelo Nataloni
  • Valentina Canella
  • Massimo Caldarelli
Original Paper

Abstract

Background

CustomBone Service (CBS) is a patient-specific, biocompatible, and osteoconductive device made of porous hydroxyapatite, indicated for cranial reconstruction in adults and children. Adult literature data report a failure rate of about 8%. The aim of this Post-Marketing Surveillance study is to verify the hypothesis that CBS in children aged 7–13 years old shows a failure rate not superior to adults.

Materials and methods

Inclusion criteria were age at implantation ranging 7–13 years old, with at least 1 year elapsed from the date of surgery. The degree of satisfaction of surgeons and patients was assessed.

Results

Data about 76 implants in 67 patients (M:F = 41:26) were obtained from 28 centers across 7 European countries. The mean age at surgery was 10.03 ± 1.72 years, with age stratification almost equally distributed. Fifty-nine subjects received one CBS, 7 subjects two and one subject received three CBS. Main etiologies were trauma (60.5%), malformation (11.8%), bone tumor (10.5%), and cerebral tumor (7.9%). Main indications to CBS were decompression (47.4%), autologous bone resorption (18.4%), tumor resection (11.8%), malformation (9.2%), comminuted fracture (5.3%), and other materials rejection (5.3%). Main implantation sites were fronto-parieto-temporal (26.3%), parietal (23.7%), frontal (11.8%), fronto-temporal (10.5%), and parieto-temporal (7.9%). CBS was chosen as first line of treatment in 63.1% of the cases. Mean follow-up was about 36 months. Eleven adverse events (14.5%) were reported in nine devices. Five CBS required explantation (three cases of infection, one fracture, and one mobilization). Failure rate was 6.58%, which is statistically not superior to the explantation rate recorded in adults (two-sided 95%, CI 2.2–14.7%). Satisfaction of surgeons and patients was of about 95%.

Conclusion

CBS is a safe and effective solution for cranial repair in pediatric patients. In particular, over the age of 7, CBS shows a rate of failure as low as in adults.

Keywords

Cranioplasty Custombone Decompressive craniectomy Precision medicine 

Notes

Compliance with ethical standards

Conflict of interest

Paolo Frassanito received a grant from Fin-ceramica Faenza S.p.A.

Angelo Nataloni and Valentina Canella are fully employed at Fin-Ceramica Faenza S.p.A.

No competing financial interests exist for the remaining authors.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Pediatric NeurosurgeryFondazione Policlinico Universitario A. Gemelli IRCSSRomeItaly
  2. 2.Pediatric NeurosurgeryFondazione Policlinico Universitario A. Gemelli IRCSS, Università Cattolica del Sacro CuoreRomeItaly
  3. 3.Fin-CeramicaFaenzaItaly

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