Cranioplasty with Individual Carbon Fibre Reinforced Polymere (CFRP) Medical Grade Implants Based on CAD/CAM Technique

Summary.

 Background: The authors present a new method for the reconstruction of large or complex-formed cranial bone defects using prefabricated, computer-generated, individual CFRP (carbon fibre reinforced plastics) medical grade implants.

 Method: CFRP is a composite material containing carbon fibres embedded in an epoxy resin matrix. It is radiolucent, heat-resistant, extremely strong and light (its weight is 20% that of steel), has a modulus of elasticity close to that of bone, and an established biocompatibility. The utilisation of a CAD/CAM (computer aided design/computer aided manufacture) technique based on digitised computed tomography (CT) data, with stereolithographic modelling as intermediate step, enabled the production of individual, prefabricated CFRP medical grade implants with an arithmetical maximum aberration in extension of less than ±0.25 mm.

 Between 1995 and February 2002, 29 patients (15 men and 14 women; mean age, 39.9 years; range, 16 to 67 years) underwent cranioplasty with CFRP medical grade implants at the neurosurgical department of the University of Vienna. Twenty-four patients were repaired secondarily (delayed cranioplasty) while 5 were repaired immediately following craniectomy (single stage cranioplasty). All cases were assessed for the accuracy of the intra-operative fit of the implant, restoration of the natural skull contour and aesthetics and adverse symptoms.

 Findings: The intra-operative fit was excellent in 93.1% and good in 6.9% of the implants. In two cases minor adjustments of the bony margin of the defect were required. The operating time for insertion ranged from 16 to 38 minutes, median 21 minutes. Postoperatively, 86.2% of the patients graded the restoration of their natural skull shape and symmetry as excellent while 13.8% termed it good. In one patient a non-space occupying subdural hygroma was found at the follow-up, but required no intervention. Two patients experienced atrophy of the frontal portion of the temporal muscle while one patient had a transient palsy of the frontal branch of the facial nerve. Over the mean follow-up period of 3.3 years (range, 0.08 to 6.8 years), there were no adverse reactions and no plate had to be removed.

 Interpretation: Individual, prefabricated CFRP medical grade implants may be considered as an alternative to conventionally utilised materials for cranioplasty, in particular in the challenging group of patients with extensive cranial defects or more complex-formed defects of the fronto-orbital or temporo-zygomatic region, guaranteeing short operating times and excellent functional and aesthetic results, which justifies the expense of their production.