Long-term follow-up of custom-made porous hydroxyapatite cranioplasty in adult patients: a multicenter European study. Can we trust self-reported complications?

Zaed, Ismail; Rossini, Zefferino; Faedo, Francesca; Fontanella, Marco Maria; Cardia, Andrea; Servadei, Franco

doi:10.23736/s0390-5616.20.05138-3

Cited by 5 publications

(11 citation statements)

References 38 publications

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“…Different from the study performed on the adult population ( 6 ), the revision rate ( |t| = 0.7433) and explantation rate ( |t| = 0.5106) between the two groups were not significantly different, making the data obtained by self-reporting neurosurgeons in pediatric cranioplasty reliable. Similarly, the rate of complications is summarized in Table 4 .…”

Section: Resultscontrasting

confidence: 79%

“…Moreover, the rate of explantation (4.5%) is similar to the rate recently reported in a large adult series of PHA CP (4.25%) ( 6 ), although the present study also included patients under 7 years of age at higher risk of complications ( 23 ).…”

Section: Discussionsupporting

confidence: 83%

“…Details about the surgical methodology were already published elsewhere ( 6 ). The current European Medical Device Regulation requires post-market clinical follow-up activities to be carried out by manufacturers to evaluate device performance and safety.…”

Section: Methodsmentioning

confidence: 99%

“…To overcome the limitations of autologous cranioplasty in children, several heterologous materials have been developed recently such as porous hydroxyapatite (PHA), titanium, polyetheretherkone (PEEK), and polymethylmethacrylate (PMMA) ( 6 ).…”

Section: Introductionmentioning

confidence: 99%

“…In this study, the authors evaluated cranioplasty complication rate in a multicentric cohort of pediatric patients who underwent PHA cranioplasty, and compared these results with a company post-market clinical analysis to see the reliability of self-reported complications by surgeons in the field of pediatric cranioplasty, as previously performed on the adult population ( 6 ). Lack of reported complications to the manufacturing company makes it difficult to compare these reports to any other study published by neurosurgical centers.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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BackgroundCranioplasty (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.MethodsThe 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 (Post-Marketing Surveillance, PMS group). The endpoints were the incidence of adverse events and related implant removal. The clinical data were compared to the company-based register including all patients under the age of 16 who received the same implant from January 1, 2004 to December 31, 2020, and the collecting complications voluntarily reported by surgeons (Database, DB group).ResultsThe 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.ConclusionsDifferent 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.

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Section: Resultscontrasting

confidence: 79%

Section: Discussionsupporting

confidence: 83%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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Prevalence of Postoperative Complications of Autologous and Heterologous Cranioplasty in the Pediatric Population: A Systematic Review of the Literature

et al. 2022

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Introduction. Cranial reconstruction (CR) is a neurosurgical procedure performed to restore the cranial vault after a decompressive craniectomy. There are contrasting reports from the literature about the complications related to the use of heterologous materials for CR in the pediatric population. In this study, the authors we try to better define such rate of adverse events for autologous and heterologous materials Material and method. A systematic review of articles published up to December 2021 was performed. Studies were included if they reported the specific use of cranioplasty materials following craniectomy in patients younger than 18 years of age, and had a minimum follow-up of at least 1 year. Results. A total of 20 studies have been selected. A total of 544 cases were included, of which 422 cases (77.6 %) with heterologous materials and 122 cases (22.4%) with autologous bone. The mean average age was 9.5 years. PEEK and PMMA reported 29% and 33.3%, respectively of complications but only 3% and 5.6%, of surgical revision. PHA reported a rate of 11.9%. Titanium reported 9.2% complications and 4.1% of surgical revisions. Porous polyethylene had a complication rate of 36.4% and a revision rate of 0%. Conclusion. There is still no perfect material for CR. it seems that heterologous materials are superior to autologous bone for CR is children and we may consider, whenever economical conditions will allow it, to use alloplastic material as first-line in small children

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Letter: Complications of Cranioplasty in Relation to Material: Systematic Review, Network Meta-Analysis and Meta-Regression

et al. 2021

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Long-term follow-up of custom-made porous hydroxyapatite cranioplasty in adult patients: a multicenter European study. Can we trust self-reported complications?

Cited by 5 publications

References 38 publications

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

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

Prevalence of Postoperative Complications of Autologous and Heterologous Cranioplasty in the Pediatric Population: A Systematic Review of the Literature

Letter: Complications of Cranioplasty in Relation to Material: Systematic Review, Network Meta-Analysis and Meta-Regression

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