Bruno Zanotti

Descriptive Epidemiology of Head Injury in Romagna and Trentino

We studied the occurrence of head injury in two different Italian regions: Romagna and Trentino. Both geographical areas attract large numbers of seasonal tourists. The study was carried out over 1 year (January 1, 1998 to December 31, 1998), prospectively in Romagna and retrospectively in Trentino because of their different head injury management protocols. The study was based on all admissions to hospital extracted by medical staff from the case records, and all cases were identified by the ICD-9 codes (ranges: 800.0–800.3, 801.0–801.3, 803.0–803.3, 850, 851.0–851.1, 852.0–852.1, 853.0–853.1, 854.0–854.1). The annual incidence of hospitalization for head injury was 314/100,000, 297 for Romagna and 332 for Trentino. The causes of head trauma and the type of injuries were similar to those reported in the international literature, and so were the characteristics of the population at risk. Romagna recorded a higher incidence of head injury among the elderly, probably due to the widespread use of bicycles without safety helmets. In Romagna, where neurosurgery departments exist, hospital mortality was low (8/100,000/year). Based on similar international literature findings, different prevention measures are suggested to reduce the occurrence and severity of head injury.

Custom made bioceramic implants in complex and large cranial reconstruction: A two-year follow-up ☆

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.

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.

Cranioplasty: Review of Materials.

AbstractCranioplasty remains a difficult procedure for all craniofacial surgeons, particularly when concerning the reconstruction of large lacunae in the skull. Considering the significant clinical and economic impact of the procedure, the search for materials and strategies to provide more comfortable and reliable surgical procedures is one of the most important challenges faced by modern craniofacial medicine.The purpose of this study was to compare the available data regarding the safety and clinical efficacy of materials and techniques currently used for the reconstruction of the skull. Accordingly, the scientific databases were searched for the following keywords autologous bone, biomaterials, cranial reconstruction, cranioplasty, hydroxyapatite, polyetheretherketone, polymethylmethacrylate, and titanium. This literature review emphasizes the benefits and weaknesses of each considered material commonly used for cranioplasty, especially in terms of infectious complications, fractures, and morphological outcomes.As regards the latter, this appears to be very similar among the different materials when custom three-dimensional modeling is used for implant development, suggesting that this criterion is strongly influenced by implant design. However, the overall infection rate can vary from 0% to 30%, apparently dependent on the type of material used, likely in virtue of the wide variation in their chemico-physical composition. Among the different materials used for cranioplasty implants, synthetics such as polyetheretherketone, polymethylmethacrylate, and titanium show a higher primary tear resistance, whereas hydroxyapatite and autologous bone display good biomimetic properties, although the latter has been ascribed a variable reabsorption rate of between 3% and 50%.In short, all cranioplasty procedures and materials have their advantages and disadvantages, and none of the currently available materials meet the criteria required for an ideal implant. Hence, the choice of cranioplasty materials is still essentially reliant on the surgeons preference.

Method to thicken the scalp in calvarian reconstruction.

Background: Scalp reconstruction has always been a challenging task. In our case, we report the use of INTEGRA Dermal Regeneration Flap, together with a cranioplasty for complex scalp defect. We have obtained not only an appropriate coverage of the cranial bone, but also an optimal aesthetic result. Method: We present a 24-year-old patient with a history of severe cranial trauma with sinking of the frontal bone with dural laceration and large bilateral frontal lacerocontusive focus. First, he had undergone reconstruction with the aid of autologous bone, metallic mesh, and titanium plates at a different clinical center. He arrived to our attention with exposure of the fixation devices, as well as part of the titanium plate used for the primary reconstruction. His general conditions could not allow a complex reconstructive procedure such as microsurgical flaps. The use of INTEGRA allowed us to reach the goal of a good and appropriate reconstruction, without exposing the patient to a higher-risk procedure. After the creation of a custom-made cranial implant in porous hydroxyapatite, the patient has undergone cranial bone remodeling to reach a homogeneous contour of the forehead profile. After the positioning of the implant, a single-layer INTEGRA regeneration template has been placed between the implant itself and the hypotrophic and thinned skin layer. Conclusions: The postoperative result after 16 months allowed us to observe a normal forehead profile with a normal thickness, good skin texture, and well-hidden scars.

The efficacy of custom-made porous hydroxyapatite prostheses for cranioplasty: Evaluation of postmarketing data on 2697 patients

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.

Surgical pitfalls with custom-made porous hydroxyapatite cranial implants

Aim: Cranioplasty implants are used primarily in cases of surgical cranial decompression following pathological elevations of intracranial pressure. Available bone substitutes include porous hydroxyapatite (HA) and polymethylmethacrylate. Whichever material is used, however, prosthetic cranial implants are susceptible to intra- and postsurgical complications and even failure. The aim of this study was to investigate such occurrences in HA cranioplasty implants, seeking not only to determine the likely causes (whether correlated or not with the device itself) but also, where possible, to suggest countermeasures. Methods: We analyzed information regarding failures or complications reported in postmarketing surveillance and clinical studies of patients treated worldwide with custom-made HA cranial implants (Custom Bone Service Fin-Ceramica Faenza, Italy) in the period 1997-2013. Results: The two most common complications were implant fractures (84 cases, 2.9% of the total fitted) and infections (51 cases, 1.77%). Conclusion: Although cranioplasties are superficial and not difficult types of surgery, and use of custom-made implants are often considered the easy option from a surgical perspective, these procedures are nonetheless plagued by potential pitfalls. If performed well they yield more than satisfactory results from the points of view of both the patient and surgeon, but lack of appropriate care can open the door to numerous potential sources of failure, which can compromise-even irreparably-the ability to heal.

Enhancing dermal and bone regeneration in calvarial defect surgery

Introduction: To optimize the functional and esthetic result of cranioplasty, it is necessary to choose appropriate materials and take steps to preserve and support tissue vitality. As far as materials are concerned, custom-made porous hydroxyapatite implants are biomimetic, and therefore, provide good biological interaction and biointegration. However, before it is fully integrated, this material has relatively low mechanical resistance. Therefore, to reduce the risk of postoperative implant fracture, it would be desirable to accelerate regeneration of the tissues around and within the graft. Objectives: The objective was to determine whether integrating growth-factor-rich platelet gel or supportive dermal matrix into hydroxyapatite implant cranioplasty can accelerate bone remodeling and promote soft tissue regeneration, respectively. Materials and Methods: The investigation was performed on cranioplasty patients fitted with hydroxyapatite cranial implants between 2004 and 2010. In 7 patients, platelet gel was applied to the bone/prosthesis interface during surgery, and in a further 5 patients, characterized by thin, hypotrophic skin coverage of the cranial lacuna, a sheet of dermal matrix was applied between the prosthesis and the overlying soft tissue. In several of the former groups, platelet gel mixed with hydroxyapatite granules was used to fill small gaps between the skull and the implant. To confirm osteointegration, cranial computed tomography (CT) scans were taken at 3-6 month intervals for 1-year, and magnetic resonance imaging (MRI) was used to confirm dermal integrity. Results: Clinical examination performed a few weeks after surgery revealed good dermal regeneration, with thicker, healthier skin, apparently with a better blood supply, which was confirmed by MRI at 3-6 months. Furthermore, at 3-6 months, CT showed good biomimetism of the porous hydroxyapatite scaffold. Locations at which platelet gel and hydroxyapatite granules were used to fill gaps between the implant and skull appeared to show more rapid integration of the implant than untreated areas. Results were stable at 1-year and remain so to date in cases where follow-up is still ongoing. Conclusions: Bone remodeling time could be reduced by platelet gel application during cranioplasty with porous hydroxyapatite implants. Likewise, layering dermal matrix over such implants appears to promote dermal tissue regeneration and the oshtemo mimetic process. Both of these strategies may, therefore, reduce the likelihood of postsurgical fracture by promoting mechanical resistance.