A randomised controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty: long-term follow-up.

Abstract

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 1year-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 12months follow-up and there had been no failures beyond 12months. 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 12months presented 1year 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 24months, 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 12months 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.