CustomBone Service

Custom-Made Implant for Cranioplasty

CustomBone Service

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 and its Commercial Partners have combined their strengths to provide innovative and effective therapeutic solutions designed to satisfy the needs of both the surgeon and patient. Finceramica has specialised in the development and technology of bio-ceramic materials. Together with Commercial Partners, Finceramica maintains a constant information exchange with the leading neurosurgeons.

Finceramica Team works in complete synergy with Commercial Partners to provide the surgeon with state-of-the-art technical support during the entire CustomBone 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.

CustomBone Service (CBS) is a custom-made 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 CustomBone Service the ideal candidate for replacing cranial bone defect in a physiological manner.

CustomBone

TECHNICAL SPECIFICATIONS

Materials A

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 CustomBone 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, CustomBone’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).

  1. 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. 
  2. Martinetti R, Dolcini L, Mangano C. 2005. Physical and chemical aspects of a new porous hydroxyapatite. Anal Bioanal Chem 381(3):634-638. 
  3. 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 
  4. 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
  5. 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. 
  6. 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 
  7. 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 
  8. 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 
  9. 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.



(*) 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 J Neurosurg Sci. 2016 May 13

CustomBone

INDICATIONS

CustomBone Service is intended to replace bone voids in the cranial and/or craniofacial skeleton. This device may be used both for adult and paediatric patients (for children above 2 years of age).

CustomBone custom-made implants are suitable for reconstructing cranial 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.  
Explore resources by product

CLINICAL STUDIES

Clinical paper
01/2025 - I. Zaed et al. Cranioplasty infection in porous hydroxyapatite: potential antibacterial properties. » Learn more Download Download PDF
Keyword: Infections Antibacterial properties
Clinical paper
01/2025 - R. Carbonaro et al. Long term series of Custom-Bone porous hydroxyapatite cranioplasty: outcomes and survival at 15 years. » Learn more Download Download PDF
Keyword: Adult Post-op complications
Clinical paper
11/2024 - R. Messina et al. Early Osteointegration in “one-step” resection and reconstruction using Porous Hydroxyapatite Custom Made implants for skull-infiltrating tumors: a monocentric prospective series. » Learn more Download Download PDF
Keyword: Adult One Step Osteointegration
Clinical paper
11/2024 - R. Carbonaro et al. Cranioplasty With Hydroxyapatite Implants: A Multidisciplinary Approach of Neurosurgeon and Plastic Surgeons to Improve Surgical Technique and Clinical Outcome. » Learn more
Keyword: Surgical Technique
Clinical paper
10/2024 - R. Maduri, B. Zanotti. Cranioplasty with porous hydroxyapatite custom made implants: a multidisciplinary approach to improve surgical technique. » Learn more
Keyword: Surgical Technique
Clinical paper
09/2024 - B. Zanotti, A.C. Salgarelli. Human Histological Osteointegration Post-Operative Analysis in Porous Hydroxyapatite Custom Made Cranial Reconstruction: a case report.
Keyword: Adult Osteointegration
Clinical paper
09/2024 - Z. Gachouch et al. Role of cranioplasty in the management of decompressive craniectomies: Study of the Adolphe de Rothschild Foundation Hospital cohort over 7 years. » Learn more
Keyword: Adult Post-op complications
Clinical paper
08/2024 - GP. Zambon et al. Osteointegration of porous hydroxyapatite ceramic implant for pediatric cranioplasty: a pediatric case report with 12 years of follow-up. » Learn more
Keyword: Pediatric Osteointegration
Clinical paper
02/2024 - F. Mannella et al. Long-term follow-up of custom-made porous hydroxyapatite cranioplasties: analysis on infections in adult and pediatric patients. » Learn more
Keyword: Adult Pediatric Infections
Clinical paper
09/2023 - A. Vandenbulcke, R. Maduri. Use of PEEK clamps to fix hydroxyapatite cranial implants: a pediatric case report.
Keyword: Pediatric Surgical Technique