Abstract
In neurosurgery, cranioplasty (CP) stands as a pivotal surgical intervention, particularly following head trauma or various neurosurgical interventions. This study scrutinizes the intricacies of CP, emphasizing its prevalence and associated complications, with a specific focus on custom-made porous hydroxyapatite (PHA) implants. The investigation spans 687 patients (with 80 patients of pediatric age, less than 14 years old) across 26 neurosurgical centers in five European countries. Methodologically, this study delves into patient characteristics, complications, and infection data through a comprehensive post-marketing on-site surveillance approach. Notably, infections emerged as the primary complication, affecting 41 patients (6% of implants) with a clear distinction in onset patterns between pediatric (with more infections, 10% versus 5.4% in adults and an earlier onset of complications) and adult populations. Out of these 41 cases, cranioplasty explantation was required in 30 patients, 4.4% of the total population. Furthermore, bifrontal decompression correlated with a significantly elevated infection risk as compared to unilateral decompression (12.5% versus 5.1%) which remains after the examination of possible confounding factors. These findings provide substantial insights into the complexities of CP, suggesting the necessity for tailored strategies in pediatric and adult cases and cautioning against bifrontal decompressions. Despite acknowledging limitations and calling for prospective studies with long term follow-up, this research advances our understanding of the use of PHA CP, guiding clinical decision-making and emphasizing the importance of customized approaches for diverse patient cohorts.