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Published in: Acta Neurochirurgica 1/2015

01-01-2015 | Clinical Article - Pediatrics

Post-marketing surveillance of CustomBone Service implanted in children under 7 years old

Authors: Paolo Frassanito, Gianpiero Tamburrini, Luca Massimi, Concezio Di Rocco, Angelo Nataloni, Greta Fabbri, Massimo Caldarelli

Published in: Acta Neurochirurgica | Issue 1/2015

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Abstract

Background

The CustomBone Service is a bioceramic implant suitable for cranial repair in both adults and children, although there are no clinical data about its use in children under 7 years of age. This surveillance study investigates the outcome in this age group.

Method

Twenty-eight children under 7 years old (range, 2.5–6 years) received CustomBone Service from July 2006 to May 2013 in 16 international hospitals. Data of 23 children (12 males and 11 females), harboring 24 prosthesis, were available with a minimum follow-up of 1 year.

Findings

Sites of the cranial defect were frontal or parietal (20.8 % each), parieto-temporal (16.7 %), fronto-parietal or occipital (12.5 % each), fronto-parieto-temporal or fronto-temporal (8.3 % each). Initial diseases were trauma (54.2 %), malformation (37.5 %), or tumor of the bone/skin (8.3 %). Rupture of the implant occurred in a single case during the implant (1/26 surgeries, 3.8 %) and the cranial repair was achieved by means of the back-up prosthesis. Five adverse events were registered during the follow-up period consisting of three cases of fracture and two of exposure/infection of the prosthesis. All cases required the removal of the device (20.8 %).

Conclusions

The failure rate of CustomBone Service under 7 years of age was higher than reported in adults and children over 7 years old (20.8 vs. 3.8 %), However, CustomBone Service may be considered a valid option under 7 years old since other materials are burdened by more significant rates of complications in the long-term period. Due to specific properties of this material, indication to CustomBone Service in toddlers should be carefully evaluated by the surgeon on a case-by-case basis.
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Metadata
Title
Post-marketing surveillance of CustomBone Service implanted in children under 7 years old
Authors
Paolo Frassanito
Gianpiero Tamburrini
Luca Massimi
Concezio Di Rocco
Angelo Nataloni
Greta Fabbri
Massimo Caldarelli
Publication date
01-01-2015
Publisher
Springer Vienna
Published in
Acta Neurochirurgica / Issue 1/2015
Print ISSN: 0001-6268
Electronic ISSN: 0942-0940
DOI
https://doi.org/10.1007/s00701-014-2254-y

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