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Paediatric cranial defect reconstruction using bioactive fibre-reinforced composite implant: early outcomes

  • Clinical Article - Pediatrics
  • Published:
Acta Neurochirurgica Aims and scope Submit manuscript

Abstract

Background

In children, approximately half of cryopreserved allograft bone flaps fail due to infection and resorption. Synthetic materials offer a solution for allograft bone flap resorption. Fibre-reinforced composite with a bioactive glass particulate filling is a new synthetic material for bone reconstruction. Bioactive glass is capable of chemically bonding with bone and is osteoinductive, osteoconductive and bacteriostatic. Fibre-reinforced composite allows for fabricating thin (0.8 mm) margins for implant, which are designed as onlays on the existing bone. Bioactive glass is dissolved over time, whereas the fibre-reinforced composite serves as a biostable part of the implant, and these have been tested in preclinical and adult clinical trials. In this study, we tested the safety and other required properties of this composite material in large skull bone reconstruction with children.

Method

Eight cranioplasties were performed on seven patients, aged 2.5–16 years and having large (>16 cm2) skull bone defects. The implant used in this study was a patient-specific, glass-fibre-reinforced composite, which contained a bioactive glass particulate compound, S53P4.

Results

During follow-up (average 35.1 months), one minor complication was observed and three patients needed revision surgery. Two surgical site infections were observed. After treatment of complications, a good functional and cosmetic outcome was observed in all patients. The implants had an onlay design and fitted the defect well. In clinical and imaging examinations, the implants were in the original position with no signs of implant migration, degradation or mechanical breakage.

Conclusions

Here, we found that early cranioplasty outcomes with the fibre-reinforced composite implant were promising. However, a longer follow-up time and a larger group of patients are needed to draw firmer conclusions regarding the long-term benefits of the proposed novel biomaterial and implant design. The glass-fibre-reinforced composite implant incorporated by particles of bioactive glass may offer an original, non-metallic and bioactive alternative for reconstruction of large skull bone defects in a paediatric population.

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Acknowledgements

The authors express their gratitude to the researcher team of the BioCity Turku Biomaterials Research Program (www.biomaterials.utu.fi) and principal financing partners of the FRC implant research: Finnish Agency for Technology and Innovation (TEKES), Academy of Finland and European Commission (Grant: NEWBONE NMP3-CT-006-026279-2), Turku University Hospital and Oulu University Hospital.

Robert M. Badeau, Ph.D., of Aura Professional English Consulting, Ltd (www.auraenglish.com), is acknowledged for this manuscript’s language content editing.

Disclosure

Author contributions to the study and manuscript preparation include the following. Conception and design: Aitasalo, Serlo, Vuorinen. Acquisition of data: all authors. Analysis and interpretation of data: all authors. Drafting the article: Piitulainen, Posti. Implant designing and material expertise and implant fabrication: Vallittu. Critically revising the article: all authors. Reviewed submitted version of manuscript: all authors. Approved the final version of the manuscript on behalf of all authors: Piitulainen.

Conflicts of interest

Authors J.P., J.P.P., V.V. and W.S. have received financial support in the form of a congress fee and travel expenses paid by Skulle Implants Corporation.

Authors K.A. and P.V. are Board Members and shareholders of Skulle Implants Corporation, which aims to commercialise FRC implants.

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Authors and Affiliations

  1. Division of Surgery and Cancer Diseases, Department of Otorhinolaryngology - Head and Neck Surgery, Turku University Hospital, PO Box 52, 20521, Turku, Finland

    Jaakko M. Piitulainen & Kalle M. J. Aitasalo

  2. Division of Clinical Neurosciences, Department of Neurosurgery, Turku University Hospital, Turku, Finland

    Jussi P. Posti & Ville Vuorinen

  3. Department of Biomaterials Science and Turku Clinical Biomaterials Centre - TCBC, Institute of Dentistry, University of Turku, Turku, Finland

    Jaakko M. Piitulainen & Pekka K. Vallittu

  4. City of Turku Welfare Division, Oral Health Care, Turku, Finland

    Pekka K. Vallittu

  5. Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland

    Willy Serlo

Authors
  1. Jaakko M. Piitulainen
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  2. Jussi P. Posti
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  3. Kalle M. J. Aitasalo
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  4. Ville Vuorinen
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  5. Pekka K. Vallittu
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  6. Willy Serlo
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Corresponding author

Correspondence to Jaakko M. Piitulainen.

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Piitulainen, J.M., Posti, J.P., Aitasalo, K.M.J. et al. Paediatric cranial defect reconstruction using bioactive fibre-reinforced composite implant: early outcomes. Acta Neurochir 157, 681–687 (2015). https://doi.org/10.1007/s00701-015-2363-2

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  • DOI: https://doi.org/10.1007/s00701-015-2363-2

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