CustomizedBone
CustomizedBone Service
Customized Implant for Cranioplasty
Science and research are an integral part of Finceramica’s DNA.
Finceramica’s research activity is aligned with the innovation in biomimetic regenerative medicine of today and tomorrow.
Finceramica has collaborated to provide effective therapeutical solutions through the development and technology of bio-ceramic materials, while paying particular attention to the development of patient specific solutions designed to satisfy the needs of both surgeon and patient.
Cranial reconstruction of large and complex skull defects is no longer considered simply a matter of the aesthetics but neurological and psychological side effects must also be taken into account.
Through use of an advanced and bio-mimetic ceramic material, CustomizedBone Service provides a proven solution for bone replacement for adult and pediatric patients (above 7 years).
Finceramica team works to provide the surgeon with cutting-edge technical support during the entire CustomizedBone Service process.
Cranial reconstruction is a complex surgical procedure associated with high morbidity rates, regardless of the material chosen. Different solutions have been developed and deeply investigated over the years to find out the “ideal material”, which might be biocompatible and able to osteointegrate with the host bone, mechanically resistant, osteoconductive and resistant to infection.
CustomizedBone Service (CBS) is a patient-specific cranial implant made of hydroxyapatite (HA), a Ca/P-derivative with chemico-physical features and a 3D porous structure which resembles the mineral component and structure of human bone. Compared to other alloplastic alternatives on the market (i.e. PMMA, PEEK, Titanium), these peculiar properties make CustomizedBone Service an ideal candidate for replacing cranial bone defect in a physiological manner.
CustomizedBone
TECHNICAL SPECIFICATIONS
The importance of bio-mimetic materials
In modern medical science, the concept and application of bio-mimetic materials has been consolidated and incorporated into everyday clinical practice. These bio-mimetic materials are defined as synthetic materials with a chemical composition and structure that resembles the mineral component of human bones.
For CustomizedBone Service, the research team at Finceramica has transferred this concept into reality through the development of a bio-mimetic ceramic biomaterial based on macro and micro porous hydroxyapatite, a major (70%) component of human bone (1,2).
Specific bio-mimetic chemical composition combined with an elevated interconnected porosity plays a decisive role in the osteointegration and healing processes. In particular, CustomizedBone’s interconnected pores favor migration and attachment of the progenitor bone cells responsible for osteointegration (3,4). Based on CT studies, the implants demonstrate an effective osteointegration (3, 5-9).
- Peyrin F, Mastrogiacomo M, Cancedda R, Martinetti R. “SEM and 3D synchrotron radiation micro-tomography in the study of bioceramic scaffolds for tissue-engineering applications”. Biotechnol Bioeng. 2007 Jun 15;97(3):638-48.
- Martinetti R, Dolcini L, Mangano C. 2005. Physical and chemical aspects of a new porous hydroxyapatite. Anal Bioanal Chem 381(3):634-638.
- Lucia Martini, Guido Staffa, Gianluca Giavaresi, Francesca Salamanna, Annapaola Parrilli, Elena Serchi, Daniele Pressato, Elena Arcangeli, Milena Fini. 2012. Long-term results following Cranial Hydroxyapatite Proshtesis Implantation in a Large Skull Defect Model. Plastic and Reconstructive Surgery. 625-635
- Maddalena Mastrogiacomo, Silvia Scaglione, Roberta Martinetti, Laura Dolcini, Francesco Beltrame, Ranieri Cancedda, Rodolfo Quarto. Role of scaffold internal structure on in vivo bone formation in macroporous calcium phosphate bioceramics. 2006. Biomaterials
- Staffa G, Barbanera A, Faiola A, Fricia M, Limoni P, Mottaran R, Zanotti B, Stefini R. “Custom made bioceramic implants in complex and large cranial reconstruction: a two-year follow-up ». J Craniomaxillofac Surg. 2012 Apr;40(3):e65-70.
- Zaccaria L, SJ Tharakan, Altermatt S “Hydroxyapatite ceramic implants for cranioplasty in children: a single-center experience” Childs Nerv Syst. 2017 Feb;33(2):343-348
- Fricia M, Passanisi M, Salamanna F, Parrilli AP, Giavaresi G, Fini M. “Osteointegration in Custom-made Porous Hydroxyapatite Cranial Implants: From Reconstructive Surgery to Regenerative Medicine” World Neurosurg. 2015 Aug;84(2):591.e11-6
- Messina G, Dones I, Nataloni A, Franzini A.“Histologically demonstrated skull bone integration in a hydroxyapatite prosthesis in a human”Acta Neurochir (Wien). 2011 Aug;153(8):1717-8
- Sprio S, Fricia M, Maddalena G, Nataloni A, Tampieri A “Osteointegration in cranial bone reconstruction: a goal to achieve” J Appl Biomater Funct Mater 2016; 14(4): e470-e476
The unique properties of bio-ceramic material
- Macro-and micro-porosity;
- Chemical and morphological biomimetic structure similar to the mineral component of human bone, enhancing osteointegration through progenitor bone cells migration and adhesion;
- Highly bio-compatible material, showing a reduce post-op infection incidence than titanium-based implants (*);
- The porous structure and hydrophilic surface allow for loco-regional use of antibiotics, when deemed clinically useful by the surgeon (**, ***);
- Natural aesthetic result leading to high level of patient satisfaction
- Completely radiolucent allowing for MRI diagnostics without artifacts.
(*) Data consider both local and systemic infections, Lindner D, Schlothofer-Schumann K, Kern BC, Marx O, Müns A, Meixensberger J. Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial.
J Neurosurg. 2017 Jan;126(1):175-183.
(**) Nataloni A., Martinetti R., Staffa G., Servadei F. Rifamicine release from porous hydroxyapatite as anti-infection prophylactic for the cranial theca reconstruction.
(***) Iaccarino C, Mattogno PP, Zanotti B, Bellocchi S, Verlicchi A, Viaroli E, Pastorello G, SGULò F, Ghadirpour R, Servadei F Septic complication following porous hydroxyapatite cranioplasty: prosthesis retention management
CustomizedBone
INDICATIONS
CustomizedBone Service is intended to replace bone voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device may be used both for adult and paediatric patients (for children 7 years of age and above).
CustomizedBone Service implants are suitable for reconstructing cranial and/or craniofacial defects resulting from:
- Trauma and vascular pathologies, either associated or non-associated to cranial decompression;
- Removal of tumours;
- Reabsorption of autologous bone;
- Rejection of other prosthetic materials;
- Congenital malformations.
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CLINICAL STUDIES
