Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty

Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial

The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.

Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.

Inclusion Criteria:

1. Skull defects without the possibility to be covered with the missing own bone
2. Size of the defect ≥ 16 cm2
3. Age ≥ 18
4. Written informed consent of the patient

Exclusion Criteria:

1. Active tumor
2. ASA 4 classification
3. Allergic disposition to ceramic or titanium
4. Concomitant participation in other clinical trials
5. Pregnant or nursing women
6. Expected low compliance
7. HIV positive
8. Active drug abuses