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

Research output: Contribution to journalArticle

6 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2283-2289
Number of pages7
JournalChild's Nervous System
Volume34
Issue number11
DOIs
Publication statusPublished - Nov 1 2018

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Durapatite
Marketing
Age Groups
Pediatrics
Patient Satisfaction
Comminuted Fractures
Equipment and Supplies
Neoplasms
Bone Resorption
Decompression
Bone and Bones
Wounds and Injuries
Infection
Surgeons
Therapeutics

Keywords

  • Cranioplasty
  • Custombone
  • Decompressive craniectomy
  • Precision medicine

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Clinical Neurology

Cite this

Custom-made hydroxyapatite for cranial repair in a specific pediatric age group (7–13 years old) : a multicenter post-marketing surveillance study. / Frassanito, Paolo; Massimi, Luca; Tamburrini, Gianpiero; Bianchi, Federico; Nataloni, Angelo; Canella, Valentina; Caldarelli, Massimo.

In: Child's Nervous System, Vol. 34, No. 11, 01.11.2018, p. 2283-2289.

Research output: Contribution to journalArticle

Frassanito, Paolo ; Massimi, Luca ; Tamburrini, Gianpiero ; Bianchi, Federico ; Nataloni, Angelo ; Canella, Valentina ; Caldarelli, Massimo. / Custom-made hydroxyapatite for cranial repair in a specific pediatric age group (7–13 years old) : a multicenter post-marketing surveillance study. In: Child's Nervous System. 2018 ; Vol. 34, No. 11. pp. 2283-2289.
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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.",
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AU - Frassanito, Paolo

AU - Massimi, Luca

AU - Tamburrini, Gianpiero

AU - Bianchi, Federico

AU - Nataloni, Angelo

AU - Canella, Valentina

AU - Caldarelli, Massimo

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N2 - 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.

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