Skip to main content

Advertisement

SpringerLink
Log in

Custom-made hydroxyapatite for cranial repair in a specific pediatric age group (7–13 years old): a multicenter post-marketing surveillance study

  • Original Paper
  • Published:
Child's Nervous System Aims and scope Submit manuscript

Abstract

Background

CustomBone Service (CBS) is a patient-specific, biocompatible, and osteoconductive device made of porous hydroxyapatite, indicated for cranial reconstruction in adults and children. Adult literature data report a failure rate of about 8%. The aim of this Post-Marketing Surveillance study is to verify the hypothesis that CBS in children aged 7–13 years old shows a failure rate not superior to adults.

Materials and methods

Inclusion criteria were age at implantation ranging 7–13 years old, with at least 1 year elapsed from the date of surgery. The degree of satisfaction of surgeons and patients was assessed.

Results

Data about 76 implants in 67 patients (M:F = 41:26) were obtained from 28 centers across 7 European countries. The mean age at surgery was 10.03 ± 1.72 years, with age stratification almost equally distributed. Fifty-nine subjects received one CBS, 7 subjects two and one subject received three CBS. Main etiologies were trauma (60.5%), malformation (11.8%), bone tumor (10.5%), and cerebral tumor (7.9%). Main indications to CBS were decompression (47.4%), autologous bone resorption (18.4%), tumor resection (11.8%), malformation (9.2%), comminuted fracture (5.3%), and other materials rejection (5.3%). Main implantation sites were fronto-parieto-temporal (26.3%), parietal (23.7%), frontal (11.8%), fronto-temporal (10.5%), and parieto-temporal (7.9%). CBS was chosen as first line of treatment in 63.1% of the cases. Mean follow-up was about 36 months. Eleven adverse events (14.5%) were reported in nine devices. Five CBS required explantation (three cases of infection, one fracture, and one mobilization). Failure rate was 6.58%, which is statistically not superior to the explantation rate recorded in adults (two-sided 95%, CI 2.2–14.7%). Satisfaction of surgeons and patients was of about 95%.

Conclusion

CBS is a safe and effective solution for cranial repair in pediatric patients. In particular, over the age of 7, CBS shows a rate of failure as low as in adults.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Lindner D, Schlothofer-Schumann K, Kern B-C, Marx O, Müns A, Meixensberger J (2016) Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial. J Neurosurg 126:1–9. https://doi.org/10.3171/2015.10.JNS151245

    Article  Google Scholar 

  2. Iaccarino C, Viaroli E, Fricia M, Serchi E, Poli T, Servadei F (2015) Preliminary results of a prospective study on methods of cranial reconstruction. J Oral Maxillofac Surg Off J Am Assoc Oral Maxillofac Surg 73:2375–2378. https://doi.org/10.1016/j.joms.2015.07.008

    Article  Google Scholar 

  3. Staffa G, Barbanera A, Faiola A, Fricia M, Limoni P, Mottaran R, Zanotti B, Stefini R (2012) Custom made bioceramic implants in complex and large cranial reconstruction: a two-year follow-up. J Cranio-Maxillo-fac Surg Off Publ Eur Assoc Cranio-Maxillo-fac Surg 40:e65–e70. https://doi.org/10.1016/j.jcms.2011.04.014

    Article  Google Scholar 

  4. Frassanito P, Tamburrini G, Massimi L, di Rocco C, Nataloni A, Fabbri G, Caldarelli M (2015) Post-marketing surveillance of CustomBone Service implanted in children under 7 years old. Acta Neurochir 157:115–121. https://doi.org/10.1007/s00701-014-2254-y

    Article  PubMed  Google Scholar 

  5. Beuriat P-A, Szathmari A, Grassiot B, di Rocco F, Mottolese C (2016) Why a hydroxyapatite cranioplasty can be used to repair a cranial bone defect in children: experience of 19 cases. Neurochirurgie 62:251–257. https://doi.org/10.1016/j.neuchi.2016.04.003

    Article  PubMed  Google Scholar 

  6. Zaccaria L, Tharakan SJ, Altermatt S (2016) Hydroxyapatite ceramic implants for cranioplasty in children: a single-center experience. Childs Nerv Syst ChNS Off J Int Soc Pediatr Neurosurg 33:343–348. https://doi.org/10.1007/s00381-016-3327-4

    Article  Google Scholar 

  7. Hardy H, Tollard E, Derrey S, Delcampe P, Péron JM, Fréger P, Proust F (2012) Clinical and ossification outcome of custom-made hydroxyapatite prothese for large skull defect. Neurochirurgie 58:25–29. https://doi.org/10.1016/j.neuchi.2011.09.006

    Article  CAS  PubMed  Google Scholar 

  8. Stefini R, Esposito G, Zanotti B, Iaccarino C, Fontanella MM, Servadei F (2013) Use of “custom made” porous hydroxyapatite implants for cranioplasty: postoperative analysis of complications in 1549 patients. Surg Neurol Int 4:12. https://doi.org/10.4103/2152-7806.106290

    Article  PubMed  PubMed Central  Google Scholar 

  9. Bowers CA, Riva-Cambrin J, Hertzler DA, Walker ML (2013) Risk factors and rates of bone flap resorption in pediatric patients after decompressive craniectomy for traumatic brain injury. J Neurosurg Pediatr 11:526–532. https://doi.org/10.3171/2013.1.PEDS12483

    Article  PubMed  Google Scholar 

  10. Grant GA, Jolley M, Ellenbogen RG, Roberts TS, Gruss JR, Loeser JD (2004) Failure of autologous bone—assisted cranioplasty following decompressive craniectomy in children and adolescents. J Neurosurg Pediatr 100:163–168. https://doi.org/10.3171/ped.2004.100.2.0163

    Article  Google Scholar 

  11. Josan VA, Sgouros S, Walsh AR, Dover MS, Nishikawa H, Hockley AD (2005) Cranioplasty in children. Childs Nerv Syst ChNS Off J Int Soc Pediatr Neurosurg 21:200–204. https://doi.org/10.1007/s00381-004-1068-2

    Article  CAS  Google Scholar 

  12. Martin KD, Franz B, Kirsch M, Polanski W, von der Hagen M, Schackert G, Sobottka SB (2014) Autologous bone flap cranioplasty following decompressive craniectomy is combined with a high complication rate in pediatric traumatic brain injury patients. Acta Neurochir 156:813–824. https://doi.org/10.1007/s00701-014-2021-0

    Article  PubMed  Google Scholar 

  13. Piedra MP, Thompson EM, Selden NR, Ragel BT, Guillaume DJ (2012) Optimal timing of autologous cranioplasty after decompressive craniectomy in children. J Neurosurg Pediatr 10:268–272. https://doi.org/10.3171/2012.6.PEDS1268

    Article  PubMed  Google Scholar 

  14. Kabbani H, Raghuveer TS (2004) Craniosynostosis. Am Fam Physician 69:2863–2870

    PubMed  Google Scholar 

  15. Morice A, Kolb F, Picard A, Kadlub N, Puget S (2017) Reconstruction of a large calvarial traumatic defect using a custom-made porous hydroxyapatite implant covered by a free latissimus dorsi muscle flap in an 11-year-old patient. J Neurosurg Pediatr 19:51–55. https://doi.org/10.3171/2016.8.PEDS1653

    Article  PubMed  Google Scholar 

  16. Frassanito P, Tamburrini G, Massimi L, Peraio S, Caldarelli M, di Rocco C (2017) Problems of reconstructive cranioplasty after traumatic brain injury in children. Childs Nerv Syst ChNS Off J Int SocPediatr Neurosurg 33:1759–1768. https://doi.org/10.1007/s00381-017-3541-8

    Article  Google Scholar 

  17. Frassanito P, Massimi L, Caldarelli M, Tamburrini G, di Rocco C (2014) Bone flap resorption in infants. J Neurosurg Pediatr 13:243–244. https://doi.org/10.3171/2013.6.PEDS13312

    Article  PubMed  Google Scholar 

  18. Frassanito P, Massimi L, Caldarelli M, Tamburrini G, di Rocco C (2012) Complications of delayed cranial repair after decompressive craniectomy in children less than 1 year old. Acta Neurochir 154:927–933. https://doi.org/10.1007/s00701-011-1253-5

    Article  PubMed  Google Scholar 

  19. Jaberi J, Gambrell K, Tiwana P, Madden C, Finn R (2013) Long-term clinical outcome analysis of poly-methyl-methacrylate cranioplasty for large skull defects. J Oral Maxillofac Surg Off J Am Assoc Oral Maxillofac Surg 71:e81–e88. https://doi.org/10.1016/j.joms.2012.09.023

    Article  Google Scholar 

  20. Lam S, Kuether J, Fong A, Reid R (2015) Cranioplasty for large-sized calvarial defects in the pediatric population: a review. Craniomaxillofacial Trauma Reconstr 8:159–170. https://doi.org/10.1055/s-0034-1395880

    Article  Google Scholar 

  21. Lee S-C, Wu C-T, Lee S-T, Chen P-J (2009) Cranioplasty using polymethyl methacrylate prostheses. J Clin Neurosci Off J Neurosurg Soc Australas 16:56–63. https://doi.org/10.1016/j.jocn.2008.04.001

    Article  CAS  Google Scholar 

  22. Iaccarino C, Mattogno PP, Zanotti B, et al (2016) Septic complication following porous hydroxyapatite cranioplasty: prosthesis retention management. J Neurosurg Sci

  23. Wehrli LA, Zweifel N, Weil R, Altermatt S (2012) Juvenile psammomatoid ossifying fibroma of the forehead, radical resection, and defect coverage with a hydroxyl-apatite composite-a case report. Eur J Pediatr Surg Off J Austrian Assoc Pediatr Surg Al Z Für Kinderchir 22:479–484. https://doi.org/10.1055/s-0032-1313349

    Article  Google Scholar 

  24. F-C Faenza, Data on file, pending publication

Download references

Author information

Authors and Affiliations

  1. Pediatric Neurosurgery, Fondazione Policlinico Universitario A. Gemelli IRCSS, Largo Agostino Gemelli, 8, 00168, Rome, Italy

    Paolo Frassanito

  2. Pediatric Neurosurgery, Fondazione Policlinico Universitario A. Gemelli IRCSS, Università Cattolica del Sacro Cuore, Rome, Italy

    Luca Massimi, Gianpiero Tamburrini, Federico Bianchi & Massimo Caldarelli

  3. Fin-Ceramica, Faenza, Italy

    Angelo Nataloni & Valentina Canella

Authors
  1. Paolo Frassanito
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Luca Massimi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Gianpiero Tamburrini
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Federico Bianchi
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Angelo Nataloni
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Valentina Canella
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Massimo Caldarelli
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Paolo Frassanito.

Ethics declarations

Conflict of interest

Paolo Frassanito received a grant from Fin-ceramica Faenza S.p.A.

Angelo Nataloni and Valentina Canella are fully employed at Fin-Ceramica Faenza S.p.A.

No competing financial interests exist for the remaining authors.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Frassanito, P., Massimi, L., Tamburrini, G. et al. Custom-made hydroxyapatite for cranial repair in a specific pediatric age group (7–13 years old): a multicenter post-marketing surveillance study. Childs Nerv Syst 34, 2283–2289 (2018). https://doi.org/10.1007/s00381-018-3905-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00381-018-3905-8

Keywords

Search

Navigation