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After failing of autologous cranioplasty or when the bone flap is unavailable, the alloplastic (heterologous) materials are the choice for cranial reconstruction. No agreement has been reported about the material with a significant lower risk of septic complications. This is due to extremely heterogeneous prognostic factors related not only to the material used but also to the surgical procedures and/or to the timing of the procedure. More attention should be focused on the material whose characteristic could enable a delay in bacterial colonization, where an antibiotic therapy could be effective, without need of prosthesis removal. Four cases of severe septic complication following cranioplasty with porous hydroxyapatite (HA) prosthesis are presented. Patients were conservatively treated, without heterologous bone flap removal. All of our patients presented reasons for delaying HA cranioplasty removal: patients #1, 3, and 4 had an associated shunted hydrocephalus and the need for not removing the prosthesis was related to the predictable recurrence of overshunting and/or sinking skin flap syndrome. In patient #4, the revision surgery would have also damaged the microvascular flap with latissimus dorsi muscle used by plastic surgeon for skin reconstruction. In patient #2, the patient refused revision surgery. In all cases, systemic and/or radiological signs of infection were observed. In patient #2 the infective process surrounded completely the HA prosthesis, while it was located in the epidural region in patients #1 and 4. In patient #3, a surgical curettage of the infected wound was performed over the HA prosthesis. Following prosthesis retention management with antibiotic therapy, all patients revealed systemic and/or radiological signs of sepsis resolution at follow-up. The possibility to avoid a prosthesis removal with effective antibiotic treatment is mainly due to the combination of three factors: targeted antibiotic therapy, good anatomical area revascularization (resulting of an "in situ" intake of antibiotics), and the biomimetism of HA prosthesis. Further investigations in a larger number of cases need to confirm these observations.

When a cranioplasty implant becomes infected, standard operating procedure dictates its removal and the initiation of a long course of antibiotic therapy. However, removing such a prosthesis can have a series of adverse consequences, including delayed cognitive and motor recovery, lack of brain tissue protection, unsightly deformity, and the need for two additional surgical procedures, not to mention the additional costs involved. To maintain the advantages of cranioplasty, we opted for a conservative approach (levofloxacin and rifampicin every 24 hours for 8 weeks) in a 68-year-old woman whose custom-made porous hydroxyapatite implant, fitted following aneurysm clipping, had become infected. The tissues overlying the implant were curettaged, and the patient's clinical condition, blood markers, and infection course were continuously monitored (local monitoring was performed by single-photon emission computed tomography [SPECT]/computed tomography [CT after intravenous administration of Tc-labeled antigranulocyte antibody). Blood tests and SPECT/CT evidenced a progressive reduction in phlogosis indices and infection locus, even 1 month after antibiotic therapy was commenced, and at 2 years from cranioplasty, the same tests and clinical examination were negative. At 6-year follow-up, clinical assessment revealed nothing out of the ordinary.Hence, specific cases (hydroxyapatite prosthesis, intact dura, cranial CT and magnetic resonance imaging negative for empyema, well-vascularized scalp, antibiotic-responsive bacteria) of infected cranial implant can be treated using a conservative approach consisting of appropriate antibiotic therapy, accompanied by local debridement where necessary, and assiduous monitoring of phlogosis indices and local verification via labeled-leukocyte scintigraphy. Our report, which was compiled after a long-term follow-up period, shows that this conservative procedure appears to be a viable option in cases of infected, custom-made hydroxyapatite cranioplasty, provided that some basic rules concerning clinical and instrumental standards are adhered to, as clearly stated in our report.

Objective: Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion, because of its known osteoinductive and osteoconductive properties. Considering its autogenous origin, the use of ICBG has not been associated to an increase of intraoperative or postoperative complications directly related to the surgery. However, complications related to the harvesting procedure and to the donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. The family of ceramic-based bone grafts has been widely used and studied during the last years for spine surgical procedures in order to reduce the need for iliac crest bone grafting and the consequent morbidity associated to the harvesting procedures., Patients and Methods: We report here the results of a post-market surveillance analysis performed on four independent cohorts of patients (115 patients) to evaluate the safety of three different formulations of hydroxyapatite-derived products used as bone graft extenders/substitutes for lumbar arthrodesis., Results: No intraoperative or post-operative complications related to the use of hydroxyapatite-derived products were detected, during medium and long follow up period (minimum 12 months-maximum 5 years)., Conclusions: This post-market surveillance analysis evidenced the safety of ceramic products as bone graft extenders or substitutes for spine fusion. Moreover, the evidence of the safety of hydroxyapatite-derived products allows to perform clinical studies aimed at evaluating the fusion rates and the clinical outcomes of these materials as bone graft extenders/substitutes, in order to support their use as an alternative to ICBG for spine fusion.

Purpose: Cranioplasty is a surgical intervention aimed at reestablishing the integrity of skull defects. Autologous bone is still considered the treatment of choice for cranioplasty. The aims of this study were to characterize and evaluate the efficacy of porous hydroxyapatite (HA) to fill skull defects based on its biomimetic characteristics., Methods: The authors analyzed the postmarketing data of all patients treated with custom-made porous HA prostheses (CustomBone Service). Characterization data in terms of physicochemical analysis and mechanical performance of the porous HA prostheses were also reported., Results: The low incidence of adverse events (5.72%) due to the use of HA porous custom-made prostheses for cranioplasty is related to the biomimetic performance of the prostheses. The composition and morphology of the porosity enable it to be a useful biomimetic prosthesis for the reconstruction of large and complex skull defects, also able to promote osteointegration., Conclusions: These collected and analyzed data demonstrate that porous HA is a suitable material to produce custom-made prostheses to repair craniolacunia. It is a biomimetic implant well-tolerated in both adult and pediatric patients and has been shown to be an effective and good alternative for cranial reconstruction.

Background: Although the porous hydroxyapatite (PHA) used in custom-made cranioplasty implants is a material appreciated for its biomimetic properties, before osteointegration it is initially very fragile. Nevertheless, we wondered whether this primary fragility is entirely due to brittleness or whether the surgeon's actions may influence the behavior of the material., Methods: To study the influence of the surgeon's behavior, we made a virtual model of a custom-made PHA cranioplasty implant and submitted it to three implant procedural variables using finite element methods. In the first test, a scenario in which the surgeon's design, validation, and positioning techniques are impeccable, the edges of the implant adhered well to the craniectomy margins. In the second test, a discrepancy between a portion of the perimeter of the craniectomy and the profile of the prosthesis was modeled, and in the third test, several gaps were simulated between the implant and the craniectomy margins., Results: Our mathematical model showed that when local and general discontinuities were included in the test scenarios, there was an increase in the load coming to bear on the cranioplasty implant, which amounted to 80 and 50 %, respectively., Conclusions: The fragility of custom-made PHA cranioplasty implants increases if the surgeon fails to achieve a precise design and validation, and/or an accurate surgical procedure. Nevertheless, careful attention during these phases helps to maintain the strength of the implant, given the more favorable mechanical conditions, without interfering with its biomimetic capacity.

Introduction: Large cranial defects still represent a challenge in neurosurgery. Currently different biomaterials are available for cranial reconstruction including titanium, acrylic mesh and different types of calcium phosphate-based bone grafts. The goal of surgery is a perfect fit of the implant without infection and absorption, and a good aesthetic result. This paper describes a surgical method for cranioplasty, using a customised porous hydroxyapatite (HA) prosthesis., Materials and Methods: Sixty patients treated surgically with a customised porous-HA prosthesis for large cranial defects, were followed retrospectively. A two-year follow-up was carried out with periodic visits and CT scans. Safety (the incidence of adverse events and fractures of the implant) and clinical performance (biological and cosmetic results) were evaluated., Results: Fifty one patients were followed-up, no rejection occurred and only one case of infection was recorded. Five patients had minor surgery-related complications, and no spontaneous implant fractures or mobilisation were reported. Three patients exhibited implant fractures as a result of trauma and all healed spontaneously. All patients showed a satisfactory clinical outcome with good cosmetic appearance in the early postoperative period and after a long-term follow-up., Conclusions: Cranioplasty performed with a customised porous-HA prosthesis gave a positive outcome, showing it to be an appropriate technique for use in large and complex cranial reconstruction., (Copyright © 2011 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.)