Status:
TERMINATED
Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
Universitätsklinikum Leipzig
Conditions:
Skull Defects
Cranioplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-operation...
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 empi...
Eligibility Criteria
Inclusion
- Skull defects without the possibility to be covered with the missing own bone
- Size of the defect ≥ 16 cm2
- Age ≥ 18
- Written informed consent of the patient
Exclusion
- Active tumor
- ASA 4 classification
- Allergic disposition to ceramic or titanium
- Concomitant participation in other clinical trials
- Pregnant or nursing women
- Expected low compliance
- HIV positive
- Active drug abuses
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00923793
Start Date
June 1 2009
End Date
April 1 2014
Last Update
May 21 2015
Active Locations (1)
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1
Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie
Leipzig, Saxony, Germany, 04107