Prospective observational cohort study on epidemiology, treatment and outcome of patients with traumatic brain injury (TBI) in German BG hospitals.

OBJECTIVES: Since 2000/2001, no large-scale prospective studies addressing traumatic brain injury (TBI) epidemiology in Germany have been published. Our aim was to look for a possible shift in TBI epidemiology described in other European countries, to look for possible changes in TBI management and to identify predictors of 1-year outcome especially in patients with mild TBI. DESIGN: Observational cohort study. SETTING: All patients suffering from a TBI of any degree between 1 October 2014 and 30 September 2015, and who arrived in one of the seven participating BG hospitals within 24 hours after trauma, were included. PARTICIPANTS: In total, 3514 patients were included. OUTCOME MEASURES: Initial care, acute hospital care and rehabilitation were documented using standardised documentation forms. A standardised telephone interview was conducted 3 and 12 months after TBI in order to obtain information on outcome. RESULTS: Peaks were identified in males in the early 20s and mid-50s, and in both sexes in the late 70s, with 25% of all patients aged 75 or older. A fall was the most frequent cause of TBI, followed by traffic accidents (especially bicyclists). The number of head CT scans increased, and the number of conventional X-rays of the skull decreased compared with 2000/2001. Besides, more patients were offered rehabilitation than before. Though most TBI were classified as mild, one-third of the patients participating in the telephone interview after 12 months still reported troubles attributed to TBI. Negative predictors in mild TBI were female gender, intracranial bleeding and Glasgow Coma Scale (GCS) 13/14. CONCLUSION: The observed epidemiologic shift in TBI (ie, elderly patients, more falls, more bicyclists) calls for targeted preventive measures. The heterogeneity behind the diagnosis 'mild TBI' emphasises the need for defining subgroups not only based on GCS.

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

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 ).