A new custom made bioceramic implant for the repair of large and complex craniofacial bone defects

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Abstract

Introduction

Neurosurgery and Maxillofacial Surgery Departments of Limoges University Hospital Centre have developed a new concept of a custom made ceramic implant in hydroxyapatite (HA) for the reconstruction of large and complex craniofacial bone defects (more than 25 cm2).

Materials and methods

The manufacturing process of the implants used a stereolithography technique that produces implants with three-dimensional shapes derived directly from the scan file of the patient's skull without moulding or machining. Eight patients received 8 implants between 2005 and 2008.

Results

The surgical procedure is simple and fast. The post-operative follow-up was 12 months. No major complications (infection or fracture of the implant) were observed. The cosmetic result was considered satisfactory by both patients and surgeons.

Conclusions

These new implants are well suited for reconstruction of large craniofacial bone defects (greater than 25 cm2) in adults and children over 8 years.

Introduction

Reconstruction of large cranial bone defects (Durham et al., 2003) using natural materials (autografts and allografts) (Edwards and Ousterhout, 1987; Gladstone et al., 1995; Costantino et al., 2000; Saringer et al., 2002) gives poor cosmetic results. Custom made implants (Wehmoller et al., 2004; Staffa et al., 2007, 2012; Hanasono et al., 2009, Lee et al., 2009) obtained through computer aided designing and manufacturing techniques (CAD/CAM) (Chim and Schantz, 2005; Spetzger et al., 2010) can produce excellent cosmetic results.

Neurosurgery and Maxillofacial Surgery Departments of Limoges University Hospital Centre have developed a new concept of custom made hydroxyapatite (HA) implants for reconstruction of large and complex craniofacial bone defects. These implants are made by stereolithography directly, with the size and three-dimensional shape desired, from the scan file of the patient's skull without a step of moulding or machining. This manufacturing method allows the production of implants with thin edges able to overlap the surrounding living bone. Eight patients were included in a clinical study, approved by the Committee to Protect Person for Biomedical Research of the Limousin, between 2005 and 2008.

The aim of our study was to show that it is possible to design custom made HA implants for reconstruction of large craniofacial bone defects that have both good mechanical and osteoconductive properties.

Section snippets

Manufacturing process used for the prostheses (Abouliatim et al., 2006)

CT scans of each patient's skull were carried out at the Limoges University Hospital Centre using a General Electrics Light Speed VAT 64 helical scanner, acquiring 150–180 sections of 1.25 mm every 0.9 mm, from the base of the skull to the vertex with a field of view (FOV) of 25 cm. The X-ray dose (DLP) received by the patients on the segment examined was between 800 and 900 mGy.cm. The computer data recorded by the scan was transmitted to the 3DCeram company on a CD-ROM.

The implant was

Results

Data on cranial bone defects and operating times are grouped in Table 1, Table 2, Table 3. No signs of inflammation and no movement was observed during the various examinations of surgical wounds. The size and shape of the first two implants are not perfectly adapted to the bone defect (deformation during the sintering stage) so that a small overhang was palpable. However, it was small enough to not be visible on the photographs. Palpation of the surgical site in patients 3–8 has always shown

Discussion

Our study shows that it is possible to reconstruct large craniofacial bone defects with custom made ceramic implants that have both good mechanical and osteoconductive properties. The choice of material and technical options were informed by the literature. Among the polymers, the most widely used is polymethyl methacrylate (PMMA) because of its low cost and ease of use. Custom-made implants composed of polyetheretherketone (PEEK) have recently emerged (Hanasono et al., 2009). However we do not

Conclusions

This study shows that these new hydroxyapatite implants are well suited to reconstruct large (greater than 25 cm2) or complex (front-orbital area) bone craniofacial defects. They possess qualities that we do not find in implants currently available on the market. However an efficacy study of a larger group of patients is needed to confirm these early results. On the other hand, the high cost of these implants requires the selection of patients. This method should not be used to reconstruct

Conflict of interest

Dr. Joël Brie received limited grants for his collaboration with 3DCeram Company. He does not have any financial or patent related interests with this company.

The others authors have never received any grants from 3DCeram Company and do not have any financial or patents related interests with this company.

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