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

NCT00923793 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2015-05-21

No results posted yet for this study

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.

Conditions

  • Skull Defects
  • Cranioplasty

Interventions

DEVICE

Titanium implant (CranioConstruct™)

One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered.

DEVICE

Hydroxylapatite (CustomBone)

Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.

Sponsors & Collaborators

  • Universitätsklinikum Leipzig

    collaborator OTHER

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Dirk Lindner, Dr. med. · Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00923793 on ClinicalTrials.gov