Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT00923793
Status:
TERMINATED
Last Update Posted:
2015-05-21
First Post:
2009-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty
Sponsor:
University of Leipzig
Organization:
Study Overview
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
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was stopped, due to slow recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: