Zaed Ismail, Safa Adrian, Spennato Piero, Mottolese Carmine, Chibbaro Salvatore, Cannizzaro Delia, Faggin Roberto, Frassanito Paolo, Maduri Rodolfo, Messerer Mahmoud, Servadei Franco
Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Department of Neurosurgery, IRCCS Humanitas Research Hospital, Milan, Italy.
Front Surg. 2022 Mar 23;9:848620. doi: 10.3389/fsurg.2022.848620. eCollection 2022.
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.
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 (). 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 .
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.
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.
颅骨成形术（CP）是一种旨在重建颅骨缺损完整性的外科干预措施。自体骨和不同的异体材料被用于此目的，有各种报道的相关并发症，尤其是在儿童中。本研究旨在评估多孔羟基磷灰石（PHA）CP植入治疗的多中心儿科患者队列中的并发症发生率，并评估制造公司收集的上市后临床数据的可靠性。
作者主动收集了来自欧洲不同国家20个机构的16岁以下接受PHA植入治疗患者的临床数据。数据是通过对负责患者的医生进行现场访谈获得的（）。终点是不良事件的发生率和相关的植入物取出情况。将临床数据与公司登记册进行比较，该登记册包括2004年1月1日至2020年12月31日接受相同植入物的所有16岁以下患者，以及外科医生自愿报告的收集到的并发症。
两组在人口统计学特征和并发症发生率方面相似。在主动收集的65例患者组的PMS组中，共报告了11例（16.9%）并发症。骨折和感染都是最常见的并发症，各有4例（6.2%）。在感染和骨折的情况下，仅1例患者（1.5%）需要翻修手术。报告了3例（4.5%）移位病例，其中1例（1.5%）需要手术翻修，总共3例（4.5%）需要手术翻修。平均随访时间为26.7个月。
与先前关于成人的研究不同，儿科神经外科医生更倾向于向制造公司报告与儿童颅骨重建相关的并发症。因此，这些数据可以与其他临床研究的数据进行比较。这65例患者系列中的PHA CP现场收集的并发症发生率与其他异体材料相似。
