title: 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 ).
authors.affiliation: Department of Neurosurgery, Sir Charles Gairdner Hospital, Nedlands;|Departments of 2 Neurosurgery.
authors.forename: Stephen
authors.initials: S
authors.lastname: Honeybul
authors.affiliation: Medical Engineering and Physics, and.
authors.forename: David Anthony
authors.initials: DA
authors.lastname: Morrison
authors.affiliation: Intensive Care, Royal Perth Hospital, Perth;|Schools of 5 Population Health and.|School of Veterinary & Life Sciences, Murdoch University, Perth, Western Australia, Australia.
authors.forename: Kwok M
authors.initials: KM
authors.lastname: Ho
authors.affiliation: Department of Neurosurgery, Sir Charles Gairdner Hospital, Nedlands;|Departments of 2 Neurosurgery.|Surgery, University of Western Australia, Perth; and.
authors.forename: Christopher R P
authors.initials: CR
authors.lastname: Lind
authors.affiliation: Schools of 5 Population Health and.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Geelhoed
mesh_terms: D000328:Adult; D001862:Bone Resorption; D016025:Bone Transplantation / Q000191:economics; D000077280:Bone-Anchored Prosthesis / Q000191:economics; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D019651:Plastic Surgery Procedures / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D012086:Reoperation; D012886:Skull / Q000601:surgery*; D014025:Titanium; D014182:Transplantation, Autologous / Q000191:economics; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014025:Titanium
keywords: autologous cranioplasty; decompressive craniectomy; randomized controlled trial; surgical technique; titanium cranioplasty