A randomized controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty

Abstract

OBJECTIVE Autologous bone is usually used to reconstruct skull defects following decompressive surgery. However, it is associated with a high failure rate due to infection and resorption. The aim of this study was to see whether it would be cost-effective to use titanium as a primary reconstructive material. METHODS Sixty-four patients were enrolled and randomized to receive either their own bone or a primary titanium cranioplasty. All surgical procedures were performed by the senior surgeon. Primary and secondary outcome measures were assessed at 1 year after cranioplasty. RESULTS There were no primary infections in either arm of the trial. There was one secondary infection of a titanium cranioplasty that had replaced a resorbed autologous cranioplasty. In the titanium group, no patient was considered to have partial or complete cranioplasty failure at 12 months of follow-up (p = 0.002) and none needed revision (p = 0.053). There were 2 deaths unrelated to the cranioplasty, one in each arm of the trial. Among the 31 patients who had an autologous cranioplasty, 7 patients (22%) had complete resorption of the autologous bone such that it was deemed a complete failure. Partial or complete autologous bone resorption appeared to be more common among young patients than older patients (32 vs 45 years old, p = 0.013). The total cumulative cost between the 2 groups was not significantly different (mean difference A$3281, 95% CI $−9869 to $3308; p = 0.327). CONCLUSIONS Primary titanium cranioplasty should be seriously considered for young patients who require reconstruction of the skull vault following decompressive craniectomy. Clinical trial registration no.: ACTRN12612000353897 (anzctr.org.au)

Cranioplasty: morbidity and failure

“…However, the reopening of previous incisions, dissection of scarred tissue planes as well as the use of implants can lead to many instances where sterility may be compromised in inexperienced hands and this would seem to be confirmed by the results of a recent cranioplasty trial. 22 The trial compared outcome following cranioplasty with either autologous bone or primary titanium and in order to limit confounding all procedures were performed by a single neurosurgeon (SH) using a standardised surgical technique with strict adherence to asepsis. This resulted in no primary infections in the 64 patients and the subsequent changes in management of cranioplasty procedure were such that there have been no cranioplasty infections for the past three years within the two neurotrauma hospitals in Western Australia.…”

“…22,23 Prior to 2012 there was no standardisation of either timing of the procedure, surgical technique or surgeon seniority. Indeed, in most cases the procedure was delegated to a relatively junior staff member.…”

“…21 Data were available from a recently completed randomised trial that started in 2012 and finished recruiting in the middle of 2014. 22 Following completion of the trial, data have been collected prospectively as part of an ongoing clinical audit. For the remaining patients, data were obtained retrospectively from the hospital records and the radiology picture archiving and communications system (PACS).…”

Repair of inferior sternal cleft using a titanium plate in an infant with pentalogy of Cantrell

“…Titanium plates are widely used in adults and children with skull defects, maxillofacial surgery, and thoracic defects . Advantages of titanium plates include light weight, higher strength and stiffness, plasticity, resistance to infection, good histocompatibility, and low interference with computed tomographic and magnetic resonance imaging .…”

Review of Cranioplasty after Decompressive Craniectomy

“…Some authors report lower complication with synthetic materials 825262728). Some reports say the total cumulative cost, including complication risks and treatments, was not significantly different between titanium and autologous bone flaps in United States of America & Canada 2450). The total average cost of cranioplasty was $25,000 to $29,000 at Canada, reported in 2015 20).…”