A randomised controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty: long-term follow-up
- 300 Downloads
To compare the long-term outcomes of patients who had been randomly allocated to receive primary titanium cranioplasty or autologous bone graft following decompressive craniectomy.
Sixty-four patients had been previously enrolled and randomised to receive either their own bone graft or a primary titanium cranioplasty. Functional and cosmetic outcomes had previously been assessed at 1-year following the cranioplasty procedure. Hospital records and the Picture Archiving communication system were reviewed to determine how many patients had cranioplasty failure or associated complications such as seizures beyond 1 year—with a minimum of 24-month follow-up.
Amongst the 31 patients in the titanium group (one patient had died), no patients had a partial or complete cranioplasty failure at 12 months follow-up and there had been no failures beyond 12 months. Amongst the 31 patients who had an autologous cranioplasty (one patient had died), 7 patients had complete resorption of the autologous bone such that it was adjudged a complete failure at 12-month follow-up. Five of these patients had had titanium augmentation and two patients declined further surgery. Both of these patients requested cranial augmentation for functional and cosmetic reasons subsequent to the 12-month follow-up. Another patient who had previously been noted to have moderate resorption at 12 months presented 1 year later with progressive bone flap resorption and also required subsequent augmentation for functional and cosmetic reasons. When follow-up was extended to a minimum of 24 months, use of titanium instead of autologous bone for primary cranioplasty resulted in a significant reduction in the number of patients who required rescue cranioplasty (0 vs 25%, 95% confidence interval [CI] 9.1–42.1%; p = 0.001). In addition, there were significantly less total hospital healthcare costs in those patients randomised to the titanium arm of the trial (difference = A$9999, 95%CI 2231–17,768; p = 0.015).
Bone resorption continued to occur beyond 12 months after autologous cranioplasty; use of primary titanium cranioplasty after decompressive craniectomy reduced the number of reoperations needed and the associated long-term total hospital costs.
KeywordsDecompressive craniectomy Autologous cranioplasty Titanium cranioplasty Randomised controlled trial
Stephen Honeybul—literature search, study design, data collection, manuscript preparation.
David Anthony Morrison—titanium plate manufacture, study design, manuscript preparation.
Kwok M. Ho—study design, data analysis, statistical analysis, manuscript preparation.
Christopher RP Lind—study design, data analysis, manuscript preparation.
Elizabeth Geelhoed—study design, data analysis, cost analysis, manuscript preparation.
Partially funded by Western Australian State Health Research Advisory Council ($129,500). This funding was used to cover the costs of the titanium plates manufactured at Royal Perth Hospital. The sponsor had no role in the design or conduct of this research.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed were in accordance with the ethical standards of the two hospitals that provide neurosurgical services in Western Australia (Royal Perth Hospital; EC 2012/126 and Sir Charles Gairdner Hospital; EC 2012-052) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
- 10.Hutchinson PJ, Kolias AG, Timofeev IS, Corteen EA, Czosnyka M, Timothy J, Anderson I, Bulters DO, Belli A, Eynon CA, Wadley J, Mendelow AD, Mitchell PM, Wilson MH, Critchley G, Sahuquillo J, Unterberg A, Servadei F, Teasdale GM, Pickard JD, Menon DK, Murray GD, Kirkpatrick PJ, RESCUEicp Trial Collaborators (2016) Trial of decompressive craniectomy for traumatic intracranial hypertension. N Engl J Med 375:1119–1130CrossRefPubMedGoogle Scholar
- 15.Vahedi K, Hofmeijer J, Juettler E, Vicaut E, George B, Algra A, Amelink GJ, Schmiedeck P, Schwab S, Rothwell PM, Bousser MG, van der Worp HB, Hacke W, DECIMAL, DESTINY, and HAMLET investigators (2007) Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol 6:215–222CrossRefPubMedGoogle Scholar