Ismail Zaed1,2, Zefferino Rossini3, Francesca Faedo4, Marco M Fontanella5, Andrea Cardia3, Franco Servadei4,3. 1. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy - ismailzaed1@gmail.com. 2. Department of Neurosurgery, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy - ismailzaed1@gmail.com. 3. Department of Neurosurgery, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy. 4. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy. 5. Neurosurgery, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.
Abstract
BACKGROUND: Cranioplasty 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. The aim of the study was to evaluate the complication rate in a multicentric cohort of patients underwent porous hydroxyapatite (PHA) cranioplasty implantation and to assess the validity of company post-market clinical analysis. METHODS: Authors analyzed a company-based register of 6279 PHA cranioplasty implanted all over the world. In these adult patients only self-reported complications were available. We then obtained the data of adult patients treated with custom-made porous HA prostheses (CustomBone Service) in 20 institutions from different European countries through an on-site interview with the physicians in charge of the patients (N.=494). The endpoints were the incidence of adverse events and of related implant removal. RESULTS: The groups of patients had similar demographics characteristics. The average follow-up was 26.7 months. A significantly higher number of complications was recorded in the group of patients underwent on-site interview. Thirty-nine complications were reported (7.89%) with an explantation rate of 4.25% (21 cases) in the series, compared to the data reported from the Company (complications rate of 3.3% and explantation rate of 3.1%). The most common complications were infection (4.86%), hematomas (1.22%), fractures (1.01%), mobilization (0.4%) and scar retraction (0.4%). CONCLUSIONS: Our data confirm that porous HA cranioplasty is at least as effective as other heterologous materials to repair cranial defects. Another interesting finding is that self-reporting complications by surgeons does not give a precise picture of the real rate of complications of the devices. These data in future studies need to be re-confirmed with on-site interviews.
BACKGROUND: Cranioplasty 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. The aim of the study was to evaluate the complication rate in a multicentric cohort of patients underwent porous hydroxyapatite (PHA) cranioplasty implantation and to assess the validity of company post-market clinical analysis. METHODS: Authors analyzed a company-based register of 6279 PHA cranioplasty implanted all over the world. In these adult patients only self-reported complications were available. We then obtained the data of adult patients treated with custom-made porous HA prostheses (CustomBone Service) in 20 institutions from different European countries through an on-site interview with the physicians in charge of the patients (N.=494). The endpoints were the incidence of adverse events and of related implant removal. RESULTS: The groups of patients had similar demographics characteristics. The average follow-up was 26.7 months. A significantly higher number of complications was recorded in the group of patients underwent on-site interview. Thirty-nine complications were reported (7.89%) with an explantation rate of 4.25% (21 cases) in the series, compared to the data reported from the Company (complications rate of 3.3% and explantation rate of 3.1%). The most common complications were infection (4.86%), hematomas (1.22%), fractures (1.01%), mobilization (0.4%) and scar retraction (0.4%). CONCLUSIONS: Our data confirm that porous HA cranioplasty is at least as effective as other heterologous materials to repair cranial defects. Another interesting finding is that self-reporting complications by surgeons does not give a precise picture of the real rate of complications of the devices. These data in future studies need to be re-confirmed with on-site interviews.