title: 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 ).
authors.affiliation: Department of Neurosurgery, Leipzig University, Leipzig.
authors.forename: Dirk
authors.initials: D
authors.lastname: Lindner
authors.affiliation: Department of Neurosurgery, Leipzig University, Leipzig.
authors.forename: Kathrin
authors.initials: K
authors.lastname: Schlothofer-Schumann
authors.affiliation: Department of Neurosurgery, BG Clinic Bergmannstrost, Halle; and.
authors.forename: Bodo-Christian
authors.initials: BC
authors.lastname: Kern
authors.affiliation: Department of Neurosurgery, Nuremberg Hospital, Nuremberg, Germany.
authors.forename: Omeima
authors.initials: O
authors.lastname: Marx
authors.affiliation: Department of Neurosurgery, Leipzig University, Leipzig.
authors.forename: Andrea
authors.initials: A
authors.lastname: Müns
authors.affiliation: Department of Neurosurgery, Leipzig University, Leipzig.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Meixensberger
mesh_terms: D000367:Age Factors; D017886:Durapatite; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011183:Postoperative Complications; D019736:Prostheses and Implants; D011788:Quality of Life; D019651:Plastic Surgery Procedures / Q000295:instrumentation*; D012886:Skull / Q000601:surgery*; D013697:Thermosensing; D014025:Titanium; D016896:Treatment Outcome
chemical_list: D017886:Durapatite; D014025:Titanium
keywords: AE = adverse event; CCT = cranial computed tomography; GCS = Glasgow Coma Scale; HA = hydroxyapatite; KPS = Karnofsky Performance Scale; SAE = significant AE; SF-36 = 36-Item Short Form Health Survey; cranioplasty; hydroxyapatite; mGOS = modified Glasgow Outcome Scale; prospective study; titanium