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

Abstract

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

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“…28 Reddy et al reported that there were no significant differences in the rate of postoperative infection between autologous bone and other materials including HA. 29 Some authors have reported that HA was more beneficial than titanium in terms of the infection rate and the neurological outcome, [29][30][31] and HA block also exhibited good osteoconduction and biocompatibility. [29][30][31][32] In our cases, no case had exposure to or infection of HA even after an 8.7-year follow-up period.…”

“…29 Some authors have reported that HA was more beneficial than titanium in terms of the infection rate and the neurological outcome, [29][30][31] and HA block also exhibited good osteoconduction and biocompatibility. [29][30][31][32] In our cases, no case had exposure to or infection of HA even after an 8.7-year follow-up period. Reddy et al reported one-stage reconstruction of soft tissue and skull composite defects using LDMC with vascularized rib grafts.…”

Outcomes of Cranioplasty with Preformed Titanium versus Freehand Molded Polymethylmethacrylate Implants

“…The reported infection rate ranges from 0% to 32% with up to 75% of patients requiring revision surgery. 18,19,[28][29][30][31] We report our findings of a retrospective analysis comparing hand-molded PMMA implants with CAD/CAM titanium implants for cranioplasty. In our study, the causes for craniectomy then requiring cranioplasty were comparable with available data.…”

Bioinspired Collagen Scaffolds in Cranial Bone Regeneration: From Bedside to Bench

“…Interestingly, a recent randomized controlled trial for large defects demonstrated no significant differences between HA and titanium in terms of reoperation and explantation rates which was 11.5% and 12.5%, respectively. [48] …”