CustomizedBone

patient specific
implant for cranioplasty
USA only

CustomizedBone-patient specific
implant for cranioplasty
USA only

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 bone1, 2. 
Specific bio-mimetic chemical composition combined with an elevated interconnected porosity play a role in the perimetral osteointegration process. 
In particular CustomizedBone’s interconnected macro-pores are suitable for housing cells responsible for bone regeneration3,4. Based on CT studies, the implants demonstrate perimetral 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


(*) 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
 

Customized Bone 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 above 13 years of age). 
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. 

Clinical studies

1. Etude prospective observationnelle multicentrique portant sur l’évaluation à long terme de la prothèse crânienne Custombone en France en 110 patients (In Progress)

2. Comparative prospective study Mono-Centre (CustomBone vs. Titanium) in Germany (Lipsia) of 44 patients (results published), 2016

3. Comparative multicentre prospective study (CustomBone vs. Autograft and PMMA) SINCH (Italian Society of Neurosurgery) of 100 patients (results published), 2015

4. Retrospective study Mono-Centre in France (CHU Rouen) of 8 patients, (results published), 2012

5. Retrospective study Multicentre SINCH (Italian Society of Neurosurgery) of 51 patients (results published), 2008

 

 

Publications in scientific journals 

1. 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
https://link.springer.com/article/10.1007/s00381-016-3327-4
(keyword: osteointegration, natural aesthetic results)

2. R. Carloni; C. Herlin; B. Chaput; A. De Runz; Hersant; E. Watier; N. Bertheuil: “Scalp tissue expansion above a custom-bone hydroxyapatite cranial implant to correct sequelar alopecia on a transposition flap: a case report” World Neurosurg 2016 Sep 5. pii: S1878-8750(16)30800-2. doi: 10.1016/j.wneu.2016.08.116.(2016) http://www.ncbi.nlm.nih.gov/pubmed/27609453
(keyword: surgical tips, natural aesthetic results)

3. B. Zanotti; N. Zingaretti; A. Verlicchi; M. Robiony; A. Alfieri; P.C. Parodi: “Cranioplasty: Review of Materials” Journal of Craniofacial Surgery, (2016) http://www.ncbi.nlm.nih.gov/pubmed/27548829(keyword: review)

4. C. Iaccarino; PP Mattogni; B. Zanotti; S. Bellochi; A. Verlicchi; E. Viaroli; G. Pastorello; F. Sgulò; R. Ghardirpour; F. Servadei: “Septic complication following porous hydroxyapatite cranioplasty: prosthesis retention management”. Journal of Neurosurgical Sciences (May 2016) 
http://www.ncbi.nlm.nih.gov/pubmed/27175619
(keyword: case studies, complications and biomaterial characteristics)

5. D. Lindner; K. Schlothofer-Schumann; C. Kern; O. Marx; J. Meixensberger:: “Cranioplasty of CustomBone versus CAD based Titanium - a randomized clinical trial”. Journal of Neurosurgery, 1-9, (Feb 2016). 
http://www.ncbi.nlm.nih.gov/pubmed/26918471
(keyword: biocompatibility) 

6. 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
https://www.ncbi.nlm.nih.gov/pubmed/27311430
(keyword: osteointegration)

7. M. Bruneau; R. Kamouni; F. Schoovaerts; HB Pouleau; O. De Witte: “Simultaneous Image-Guided Skull Bone Tumor Resection and Reconstruction With a Preconstructed Prosthesis Based on an OsiriX Virtual Resection”. Neurosurgery, (Aug 2015). 
http://www.ncbi.nlm.nih.gov/pubmed/26287551
(keyword: surgical technique) 

8. 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
https://www.ncbi.nlm.nih.gov/pubmed/25819529
(keyword: osteointegration)

9. C. Iaccarino; E. Viaroli; M. Fricia; E. Serchi; T. Poli; F. Servadei: “Preliminary results of a prospective study on methods of cranial reconstruction”. Journal of Oral and Maxillofacial Surgery. S0278-2391(15)01007-1.doi: 10.1016/j.joms.2015.07.008 (2015). 
http://www.ncbi.nlm.nih.gov/pubmed/26253012
(keyword: clinical studies)

10. R. Carloni; B. Hersant; R. Bosc; C. Le Guerinel; J.P. Meningaud: “Soft Tissue Expansion and Cranioplasty: For Which Indications?” Journal of Cranio-Maxillofacial Surgery, pii: S1010-5182(15)00191-2.doi:10.1016/j.jcms. (2015) 
http://www.ncbi.nlm.nih.gov/pubmed/26189146
(keyword: surgical tips)

11. B. Zanotti; A.Verlicchi; R. Stefini; A.C. Salgarelli; N. Zingaretti; P.C. Parodi; M. Casadei; M. Robiony: “Surgical pitfalls with custom-made porous hydroxyapatite cranial implants” Plastic and Aesthetic Research (journal of Asia-Pacific Association of Medical Research and European Residents in Plastic Surgery), Vol. 2, Issue 1, IP: 95.227.84.84. (January 2015) 
(keyword: surgical tips)

12. B. Zanotti; A.Verlicchi; S. Indiani; S.A. Scarparo; N. Zingaretti; P.C. Parodi: “Spontaneous fractures in custom-made porous hydroxyapatite cranioplasty implants: is fragility the only culprit?” Acta Neurochirurgica ;157(3):517-23. doi: 10.1007/s00701-014-2319-y. (January 2015) 
http://www.ncbi.nlm.nih.gov/pubmed/25588747
(keyword: biomaterial characteristics)

13.M. Fricia; M. Passanisi: “Long-term results following porous hydroxyapatite bilateral cranioplasty: an 8-year radiological follow-up”. Progress in Neuroscience, 2015, 3 (1-4): 125-128.
http://www.progressneuroscience.com/pdf/vol_3_n_1_2015/10.14588PiN.2015.Fricia.125.pdf        (keyword: long term follow-up)

14.F. Servadei, C. Iaccarino: “Perspective: The therapeutic cranioplasty still needs an ideal material and surgical timing”. World Neurosurgical. pii: S1878-8750(14)00752-9. doi: 10.1016/j.wneu.2014.08.031 (2014) 
http://www.ncbi.nlm.nih.gov/pubmed/25153284
(keyword: review)

15. A. Di Rienzo, M. Iacoangeli, L. Alvaro, R. Colasanti, M. Dobran, LG Di Somma, E. Moriconi, A. Scerrati: “The sinking bone syndrome?”. Neurologica medico-chirurgica Journal (The Japan Neurosurgical Society), 53(5):329-35 (2013) 
http://www.ncbi.nlm.nih.gov/pubmed/23708225
(keyword: surgical technique) 

16. 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. 2013;4:12. doi: 10.4103/2152-7806.106290. Epub 2013 Jan 28.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3589836/
(keyword: porosity)

17. J.-M. Lemée, D. Petit, M. Splingard, P. Menei: “Autologous bone flap versus hydroxyapatite prosthesis in first intention in secondary cranioplasty after decompressive craniectomy: A French medico-economical study”. Journal de Neurochirurgie. 10.138 (2013) 
http://www.ncbi.nlm.nih.gov/pubmed/23414773
(keyword: comparison other material)

18. A. Di Rienzo, M. Iacoangeli, LG Di Somma, L. Alvaro, N. Nocchi, A. Scerrati: “Shape modifications of porous hydroxyapatite prostheses to improve rigid implant fixation: Experience in 12 cases”. Surgical Neurology International. 3:161 (2012) 
http://www.ncbi.nlm.nih.gov/pubmed/23372977
(keyword: case studies)

19. A.T. Adetchessi; G. Pech-Gourg; P. Metellus; S. Fuentes:  “Fracture précoce d’une cranioplastie en céramique macropoereuse d’hydroxyapatite”. Journal de Neurochirurgie. Dec; 58(6):382-5 (2012)
http://www.ncbi.nlm.nih.gov/pubmed/22898300
(keyword: case report)

20.G. Staffa; A. Barbanera; A. Faiola; M. Fricia; P. Limoni; R. Mottaran; B. Zanotti; R. Stefini: “Custom made bioceramic implants in complex and large cranial reconstruction: a two-year follow-up” Journal of Cranio-Maxillofacial Surgery, 65-70 (2012) 
http://www.ncbi.nlm.nih.gov/pubmed/21640597
(keyword: porosity and osteointegration)

21. B. Zanotti; A. Verlicchi; M. Robiony; P.C. Parodi: “Surgical calvarial demolition and reconstruction: procedure, implants and results”, Topics in Medicine Journal, Vol. 16 (2011)
(keyword: surgical technique) 

22. M. Fabbri; V. Rava; A. Nataloni “From CT scan to the operating theatre: designing and producing a custom-made cranioplasty in porous hydroxapatite” Topics in Medicine Journal, Vol. 16 (2011)
(keyword: biomaterial characteristics) 

23. C. Iaccarino; V. Ramponi; R. Ghardirpour; F. Carinci; F. Servadei: “Porous hydroxyapatite custom made cranioplasty: the 3d design techniques prostheses in 21 patients”. Journal of Osteology and Biomaterials, 2 (1); 43-53 (2011)
(keyword: case studies)

24. E. Rampino Cordaro; S. Calabrese; G.P. Faini; B. Zanotti; A. Verlicchi; P.C. Parodi: “A method to thicken the scalp in calvarian reconstruction”. The Journal of Cranial Surgery, Vol. 22, 598-601 (2011)
http://www.ncbi.nlm.nih.gov/pubmed/21403566
(keyword: surgical technique) 

25. 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.
https://pdfs.semanticscholar.org/9a37/e6671eb7fbf87c429bece2baabedb80fad0b.pdf
(keyword: osteointegration)

26. A. Della Pupa; R. Mottaran; R. Scienza: “Image-guided cranial osteoma resection and bioceramic porous hydroxyapatite custom-made reconstruction in a one-step surgical procedure. Technical notes and illustrative case”. Acta Neurochirurgia n° 152, 155-159 (2010)
http://www.ncbi.nlm.nih.gov/pubmed/19430722
(keyword: case report tumor)

27.G. Staffa; A Nataloni; G. Compagnone; F. Servadei: “Custom made cranioplasty prostheses in porous hyoxyapatite using 3D design techniques: 7 years’ experience in 25 patients”. Acta Neurochirurgia n° 149, 161-170 (2007)
http://www.ncbi.nlm.nih.gov/pubmed/17242849
(keyword: case studies, natural aesthetic results)

 

28. 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.
https://www.ncbi.nlm.nih.gov/pubmed/17089389
(keyword: chemical composition and structure)

29. 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.https://mohit.pure.elsevier.com/en/publications/role-of-scaffold-internal-structure-on-in-vivo-bone-formation-in-
(keyword: porosity)

30.F. Servadei; B. Zanotti; A. Nataloni; D. Pressato; A. Verlicchi; F. Lupidi; M. Vindigni; A. Cramaro; A. Barbanera; A. Andreoli; P. Delcampe; A. Proust; M. Fricia; N. Francaviglia; P. Limoni; E. Benericetti; M. Mottaran; M. Mattana; G.B. Costella; L. Rigobello; G. Salar; G. Staffa; R. Stefini; U. Zanetti; T. Ius; M. Skrap: “La cranioplastica su misura in idrossiapatite porosa”. Rivista Medica”, Vol. 11, n° 3-4 (2005)
(keyword: case studies and biomaterial  characteristics)

31. Martinetti R, Dolcini L, Mangano C. 2005. Physical and chemical aspects of a new porous hydroxyapatite. Anal Bioanal Chem 381(3):634-638.http://europepmc.org/abstract/med/15692812
(keyword: case studies and biomaterial characteristics)

32. R. Martinetti, L. Dolcini, A. Belpassi, R. Quarto, M. Mastrogiacomo, R.Cancedda, M. Labanti. Inspired Porosity for Cells and Tissues. 2004. Bioceramics.
(keyword: osteointegration)

33. G. Staffa; F. Servadei; A Nataloni; R. Martinetti: “Design of custom-made porous hidroxyapatite devices for the reconstruction of skull: a 6 years multicentric experience”. Journal of Applied Biomaterials & Biomechanics, Vol. 1, nr 3, 214 (2003)
(keyword: case studies)

34. R. Martinetti, A. Belpassi, A. Nataloni and C. Piconi. Porous hydroxyapatite cell carrier for tissue engineering. Bioceramics. 2001.
(keyword: porosity)

35. Nataloni A., Martinetti R., Staffa G., Servadei F. “Rifamicine release from porous hydroxyapatite as anti-infection prophylactic for the cranial theca reconstruction”. 2000
(keyword: loco-regional use of antibiotics)

36. Uchida A, Araki N, Shinto Y, Yoshikawa H, Kurisaki E, Ono K. "The use of calcium hydroxyapatite ceramic in bone tumour surgery". J Bone Joint Surg Br. 1990 Mar;72(2):298-302. 
https://www.ncbi.nlm.nih.gov/pubmed/2155908
(keyword: chemical composition)

 

*Please note that outside of the US, the product is referred to as CustomBone Service.  In the US the name for the device is CustomizedBone Service.  These referenced articles may refer to the device as CustomBone Service, rather than CustomizedBone Service, however, the devices are the same.  Also please note that in the US, the device is indicated for patients above 13 years of age.