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

ABSTRACT:

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 (

SUBMITTER: Zaed I 

PROVIDER: S-EPMC8983879 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature