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

Cranioplasty Clinical Trial

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cranioplasty
• Skull Defects

• NCT number: NCT00923793
• Study type: Interventional
• Source: University of Leipzig
• Status: Terminated
• Phase: Phase 3
• Start date: June 2009
• Completion date: April 2014