- Department of Neurosurgery, University of Brescia, Spedali Civili, Brescia, Italy
- Department of Neurosurgery, S. Maria Della Misericordia Hospital, Udine, Italy
- Department of Neurosurgery-Neurotraumatology, Azienda-Ospedaliero Universitaria, Parma, Italy
Department of Neurosurgery-Neurotraumatology, Azienda-Ospedaliero Universitaria, Parma, Italy
DOI:10.4103/2152-7806.106290Copyright: © 2013 Stefini R This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
How to cite this article: Stefini R, Esposito G, Zanotti B, Iaccarino C, Fontanella MM, Servadei F. Use of “custom made” porous hydroxyapatite implants for cranioplasty: postoperative analysis of complications in 1549 patients. Surg Neurol Int 28-Jan-2013;4:12
How to cite this URL: Stefini R, Esposito G, Zanotti B, Iaccarino C, Fontanella MM, Servadei F. Use of “custom made” porous hydroxyapatite implants for cranioplasty: postoperative analysis of complications in 1549 patients. Surg Neurol Int 28-Jan-2013;4:12. Available from: http://sni.wpengine.com/surgicalint_articles/use-of-custom-made-porous-hydroxyapatite-implants-for-cranioplasty-postoperative-analysis-of-complications-in-1549-patients/
Background:Cranioplasty is a surgical intervention aimed at reestablishing the integrity of skull defects, and should be considered the conclusion of a surgical act that began with bone flap removal. Autologous bone is still considered the treatment of choice for cranioplasty. An alternative choice is bioceramic porous hydroxyapatite (HA) as it is one of the materials that meets and comes closest to the biomimetic characteristics of bone.
Methods:The authors analyzed the clinical charts, compiled by the neurosurgeon, of all patients treated with custom-made porous HA devices (Custom Bone Service Fin-Ceramica, Faenza) from which epidemiological and pathological data as well as material-related complications were extrapolated.
Results:From November 1997 to December 2010, 1549 patients underwent cranioplasty with the implantation of 1608 custom-made porous HA devices. HA was used in 53.8% of patients for decompressive craniectomy after trauma or intracranial hemorrhage, while the remaining cases were for treated for comminuted fracture, cutaneous or osseous resection, cranial malformation, autologous bone reabsorption or infection or rejection of previously implanted material. The incidence of adverse events in patients treated for cranioplasty, as first line treatment was 4.78% (56 events/1171 patients), and 5.02%, (19 events/378 patients) at second line.
Conclusion:This study demonstrates that HA is a safe and effective material, is well tolerated in both adult and pediatric patients, and meets the requirements necessary to repair craniolacunia.
Keywords: Cranioplasty, customized cranioplasty, porous hydroxyapatite prosthesis
Cranioplasty is a surgical intervention aimed at reestablishing the integrity of skull defects, usually because of previous craniotomy, and should be considered as the conclusion of a surgical act that began with bone flap removal. In the past 10 years, there has been an increase in the number of cranioplasties performed, reaching 20-25 per million inhabitants per year (Europe, Middle East and Africa, area), mainly due to an increase in the use of decompressive craniectomies.[
Autologous bone is still considered the treatment of choice for cranioplasty,[
Bioceramic porous hydroxyapatite (HA) is one of the materials that meets these features and comes closest to the biomimetic characteristics of bone. Furthermore, due to its osteo-integrability it can interact with bone tissues without producing scar tissue [
The present study reviews the worldwide case reports of cranioplasty using custom-made bioceramic porous HA, analyzing the number and type of complications directly or indirectly related to the material. This permits evaluation of the safety characteristics and identification of possible corrective suggestions in terms of design, validation, and surgical technique.
Within the context of a research study, the University of Brescia entered into an agreement with Finceramica Company to gain access to data collection forms and patient data for the purposes of the investigation. The company provided the authors with all clinical charts of patients treated with custom-made porous HA devices (Custom Bone Service Fin-Ceramica, Faenza) compiled by the requesting neurosurgeon, from which epidemiological and pathological data as well as material-related complications were extrapolated.
All data collection forms, reporting immediate or long-term postoperative material-related complications collected by the company, were analyzed in accordance with postmarket clinical follow-up surveillance (PMCF) regulations as defined in Directive 93/42/EEC. The authors verified that the data were collected in full compliance with directives of the European Commission Directorate General for Health and Consumers that oversees periodic monitoring through contacts with all users of the devices.
To demonstrate the accuracy of these data, they were compared with the same data extrapolated from unsponsored studies: two already published and two unpublished studies. The unpublished data were provided by the Italian Society of Neurosurgery and the University of Leipzig (Germany).
In the first published study by Staffa,[
In the second published study by Hardy,[
The third study, unpublished, is a German study conducted by the University of Leipzig, a randomized clinical trial comparing HA versus titanium for craniofacial reconstruction. On December 31, 2010, 16 patients with a HA device were included, and there were no adverse events. The postoperative follow up visit was at 1 and 6 months, with an optional CT scan at 1 and 6 months.
The fourth study, unpublished, by Italian Neurosurgical Society (SINCH), is a prospective, multicentric, observational study in cranial lacunia reconstruction. On December 31, 2010, 48 patients were recruited and 1 adverse event was seen. The postoperative follow-up visits were at 3, 6, 12 months, and CT scan at 6 and 12 months.
Patients who underwent cranioplasty with custom-made porous HA devices were divided into two groups: group A, patients enrolled in four independent (unsponsored) clinical studies, and group B, including the remaining patients whose data were extracted from data collection forms provided to the author by the manufacturer. An inferential statistical analysis was performed to see if the two groups were homogeneous for comparison of the incidence of material-related complications between groups.
For the purposes of this study, complications were defined as any adverse postoperative event involving the implant such as fracture, infection, mobilization that did not allow it to fulfill its proper function. Adverse events related to surgery and irrelevant for the prosthesis function, such as postoperative hematoma, brain edema and ischemia, hydrocephalus, seizures or other reasons causing neurological deterioration were not taken into account.
The patients reported to the company were followed by continuous monitoring by the surgeon who implanted the device, who in case of material-related complications, reported these to the manufacturer. If a problem with the prosthesis arose, patients were required to contact their surgeon who then transmits that information to the manufacturer. No formal evaluation of patients was anticipated.
HA is the main constituent of bone (60%) and thus its use as a prosthetic material appears obvious. HA shows excellent biocompatibility due to the absence of host immune reactions[
From November 1, 1997 to December 31, 2010, 1549 patients (991 male, 558 female) underwent cranioplasty with the implant of 1608 custom-made porous HA devices (Custom-Bone Service Fin-Ceramica, Faenza). Patient age ranged between 7 and 87 years with an average of 32 years. There were 114 pediatric patients who ranged in age from 7 to 14 years. The number of cranioplasties has gradually increased from one in 1997 and 1998, to 378 in 2010 [
The implants were performed almost entirely in Europe; only 8 were implanted in the Middle East, 6 in Africa, 2 in Canada and 1 in Central America, 1 in Oceania, and 1 in South America. In Europe, the majority of prostheses were used in Italy (n = 717), followed by France (n = 322), and Germany (n = 204). Patients were recruited by 298 neurosurgical centers.
The number of defect localizations is showed in
The different localizations are not correlated directly to the etiology of the initial event since the custom-bone was second-line treatment in 378 (24.4%) patients. Sixty-one patients had wide and complex lacunae and required a double prosthesis to reconstruct the necessary curvature; 51 of these (84%) were bifrontal lesions and 10 (16%) frontal-parietal-temporal. There were 72 (4.47%) postoperative adverse events (A-pO-event) as detailed in
Mobilization of the prosthesis [
Technical note: Necessary to ensure adherence to the bone edge, which must be freshened to guarantee the maximum contact between the device and the cranium. The prosthesis is fixed with silk. It is not possible to use rigid fixing systems with this type of material, due to the risk of inducing micro-fractures in the prosthesis when it is still fragile. In the prosthesis design phase, it is required to indicate where to place the anchoring holes, dural, and muscular attachment. This is because once produced, the prosthesis can no longer be modified. The anchoring technique must be even more scrupulous in the case of extensive lacunae, which require two devices to reconstruct the necessary curvature
A characteristic intrinsic only to HA is the possibility of self repair after head trauma, all discovered a few years after the implant, which occurred in six patients.
The time elapsed between cranioplasty and the onset of infection was as follows: less than 6 months (22 patients; 66%), within 6-12 months (2 patients; 6%), and after 1 year (9 patients; 28%). The material-related complications were divided [
Autologous bone is still considered the first choice for repair of craniolacunia because of its good tolerability and favorable biological properties. However, its use presents some problems, yet unresolved, such as unavailability, resorption and unsatisfactory esthetic results in some cases. The unavailability of bone may be due to trauma with multi-fragmentary skull fractures that cannot be reconstructed and preserved, or to skull erosion due to lesions. Furthermore, the resorption of autologous bone can occur following repositioning at the cranial level and has a variable incidence in the literature ranging from 2% to 50%,[
This study analyzed the material-related complications using bioceramic custom-made porous HA. In this series, infection related to the material was seen in 2.05% of cases, which is comparable to the incidence of infections with other materials such as titanium (1.18%, range 0.7-4.5%),[
Device fractures [
The need for reoperation to refix the prosthesis was inferior with custom-made HA compared with other materials, as shown in
The removal of prefabricated implants [
The slight difference existing between the percentage of adverse events in patients treated as first intention (4.78%) and second intention (5.02%) makes bioceramic porous HA, in our opinion, the material of choice in case of failure of another material, a situation that is often complex and which occurs in patients with a high number of comorbidities.
One limitation of the present study was the source of the data as it was provided by the company that manufactures the prosthesis and reliance on the surgeon for reporting all adverse events. The data are, however, monitored by annual inspections at the company by the Ministry of Italian Health that foresees periodic monitoring through contact with all users of the device. In addition, comparison of the data relative to complications in group A coming from retrospective and prospective studies performed at the national and international level[
Finally, there were no differences between material-related complications in pediatric and adult patients.
This extensive series of cranioplasties with a single material, previously unreported in the literature, demonstrates that porous HA is a safe and effective material that is well tolerated in both adult and pediatric patients, and that it meets the requirements necessary to repair craniolacunia. The initial fragility (lower strength) of the prosthesis has led to the design of a thicker prosthesis and to meticulous refinement of surgical technique, which the surgeon must be familiar with beforehand.
The authors thank Dr. Nataloni Angelo of Fin-Ceramica Faenza S.p.A., responsible for clinical surveillance, for providing clinical data and Dr. Marco Fricia for providing the images.
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