Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial

• DOI: 10.3171/2015.10.jns151245
• Publication Date: 2016-02-26T15:05:01Z
• Authors: Dirk Lindner; Kathrin Schlothof...; Bodo-Christian Kern; Omeima Marx; Andrea Müns; Jürgen Meixensberger
• Keywords: Cranioplasty

OBJECTIVE Cranioplasty is routinely performed in neurosurgery. One of its underestimated problems the high postoperative complication rate up to 40%. Due lack good prospective studies and small number patients (5-20 each year) who receive alloplastic materials, decisions favor or against a certain material are based on subjective empirical economic reasons. The main goal this study-the first prospective, randomized multicenter study Germany-of custom-made titanium hydroxyapatite (HA) implants was compare local systemic infections related implant within 6 months after implantation. Secondary objectives included comparing reoperation rate, clinical neurological outcomes, health-related quality life. METHODS patient screening randomization at 8 weeks before operation; pre-, intra-, documentation until discharge; follow-ups 1 months. Approval for obtained from ethics committee. RESULTS A total 52 were study. implant-associated wound infection HA group 2 26 (7.7%) 5 24 (20.8%) (p = 0.407). Systemic inflammation operation affected none 4 (37.5%) 0.107). In both groups, 7 required 6-month follow-up (26.9% 29.2% group; not significant). Reoperation with an explantation necessary 3 (11.5% 12.5% results demonstrated significantly higher epidural hematomas comparison group. Altogether, 46 adverse events found 27 (54%). An improvement outcome experienced by 43% 26.3% 0.709). CONCLUSIONS emphasizes that cranioplasty high-risk intervention. titanium, shows benefits terms outcome, but same time has risk hematoma. Depending individual conditions, materials have their place future therapies. Clinical trial registration no.: NCT00923793 ( clinicaltrials.gov ).