A Multicentric European Clinical Study on Custom-Made Porous Hydroxyapatite Cranioplasty in a Pediatric Population.

Background

Cranioplasty (CP) is a surgical intervention aiming to re-establish the integrity of skull defects. Autologous bone and different heterologous materials are used for this purpose, with various reported related complications, especially in children.This study aims to evaluate the rate of complication in a multicentric cohort of pediatric patients treated by porous hydroxyapatite (PHA) CP implantation and to assess the reliability of post-marketing clinical data collected by a manufacturing company.

Methods

The authors proactively collected clinical data from 20 institutions in different European countries for patients under the age of 16 treated with a PHA implant. The data were obtained by conducting an on-site interview with physicians in charge of the patients (

Results

The two groups were similar in terms of demographic characteristics and rate of complications. In the PMS group, a total of 11 (16.9%) complications were reported in the group of 65 patients that were proactively collected. Both fractures and infections were the most common complications with 4 cases each (6.2%). In the case of both infections and fractures, revision surgery was required for only one patient (1.5%). Three (4.5%) cases of displacements were reported, and in one (1.5%) case, a surgical revision was required, for a total of 3 (4.5%) cases requiring surgical revision. The average follow-up was 26.7 months.

Conclusions

Different from a previous study on adult age, pediatric neurosurgeons are more prone to report even to the manufacturing company complications related to skull reconstruction in children. Therefore, these data can be compared with those of other clinical studies. The PHA CP in this series of 65 patients presents a complication rate collected on-site that is similar to other heterologous materials.

Informations de copyright

Copyright © 2022 Zaed, Safa, Spennato, Mottolese, Chibbaro, Cannizzaro, Faggin, Frassanito, Maduri, Messerer and Servadei.

Déclaration de conflit d'intérêts

FS has received limited grants and consultancy fees from Fin-ceramica spa (producing HA cranioplasty) and Integra-Codman (commercializing HA cranioplasties) and from Johnson and Johnson (commercializing PEEK cranioplasty). PF received consultancy fees from Fin-ceramica spa (producing HA cranioplasty) and Integra-Codman (commercializing HA cranioplasties). Data from this clinical study were elaborated by the authors of this article without any commercial influence. All the remaining authors certified that they have no affiliations with or involvement in any organization or entity with any financial interests (such as honoraria, educational grants, participation in speakers' bureaus, membership, employment, consultancies, stock ownership, or other equity interest, and expert testimony or patent-licensing arrangements), or nonfinancial interests (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript.