gms | German Medical Science

Objective: Cranioplasty procedures are routinely done in neurosurgical departments. Due to the lack of prospective studies and the relative low number of patients in each hospital, decisions in favor or against a certain material are difficult. This study was prospectively planned to compare CustomBone (Codman) versus Titanium (DDI Düsseldorf). Both manufacturers produce the implants on the base of the individual CT data sets. This publication includes first data of one clinical centre.

Method: The study include the screening and randomization 6-8 weeks before operation, pre-, intra and postoperative documentation until discharge as well as follow-up after 1 and 6 month postoperatively.

Results: 44 (18f and 26m) patients were treated in one of three clinical centre. Mean age was 57, 5 years (25-71y). 23 patients (10f/13m) were included in the titanium group and 21 (8f/13m)) in the CustomBone group. Reasons for first operation were acute subdural hematoma in 12, ischemic stroke/decompression in 11, tumor operation in 12, and aneurysm operation in 7 and CSF leakage in 2 patients. Secondary reasons are infection in 26 patients, 8 with reabsorption and 2 with re-haemorrhage. Size of the cranioplasty was <100cm² in 15 patients (7 titanium and 8 CustomBone) and 29 >100m² ((16 titanium and 13 CustomBone). In 48% of the patients complications occurred. One patient died before implantation and one patient died on haemorrhage after operation because of an undetected angioma. 5 patients suffered on an epidural hematoma, with reoperation in 2 patients and explantation in one. 3 patients showed local infection with reoperation and explantation. 2 patients with shunt devices have to be reoperated with explantation of the implant. Additional complications without reoperation were new seizures in 2 patients, subgaleal seroma in 2 patients and 2 patients with local wound dehiscence. In both group complications rate was 48% with a higher number of epidural hematoma in the CustomBone group (4:1). In both groups 3 patients suffered from an infection and explantation of the implant. 78% patient of the titanium group show no changes of neurological situation, 9% were slightly better and 9% showed a new neurological deterioration. In the CustomBone group 43% were neurological better than before, 48% were idem and only one patient showed neurological deterioration.

Conclusions: Number of complication in cranioplasty with alloplastic materials is high with nearly 50%. Neurological outcome was better in the CustomBone group.