caa a22 4500 606213376 CHVBK 20210128101047.0 cr unu---uuuuu 210128e20150101xx s 000 0 eng 10.1007/s00701-014-2254-y doi (NATIONALLICENCE)springer-10.1007/s00701-014-2254-y Post-marketing surveillance of CustomBone Service implanted in children under 7years old [Elektronische Daten] [Paolo Frassanito, Gianpiero Tamburrini, Luca Massimi, Concezio Di Rocco, Angelo Nataloni, Greta Fabbri, Massimo Caldarelli] 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 7years of age. This surveillance study investigates the outcome in this age group. Method: Twenty-eight children under 7years 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 7years of age was higher than reported in adults and children over 7years old (20.8 vs. 3.8%), However, CustomBone Service may be considered a valid option under 7years 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. Springer-Verlag Wien, 2014 Bioceramic nationallicence Cranioplasty nationallicence Cranial repair nationallicence CustomBone nationallicence Hydroxyapatite nationallicence Decompressive craniectomy nationallicence Frassanito Paolo Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut Tamburrini Gianpiero Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut Massimi Luca Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut Di Rocco Concezio Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut Nataloni Angelo Fin-Ceramica, Faenza, Italy aut Fabbri Greta Fin-Ceramica, Faenza, Italy aut Caldarelli Massimo Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut Acta Neurochirurgica Springer Vienna 157/1(2015-01-01), 115-121 0001-6268 157:1<115 2015 157 701 https://doi.org/10.1007/s00701-014-2254-y text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s00701-014-2254-y text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Frassanito Paolo Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut NATIONALLICENCE 700 1- Tamburrini Gianpiero Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut NATIONALLICENCE 700 1- Massimi Luca Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut NATIONALLICENCE 700 1- Di Rocco Concezio Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut NATIONALLICENCE 700 1- Nataloni Angelo Fin-Ceramica, Faenza, Italy aut NATIONALLICENCE 700 1- Fabbri Greta Fin-Ceramica, Faenza, Italy aut NATIONALLICENCE 700 1- Caldarelli Massimo Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy aut NATIONALLICENCE 773 0- Acta Neurochirurgica Springer Vienna 157/1(2015-01-01), 115-121 0001-6268 157:1<115 2015 157 701