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

May 20, 2015 updated by: Dirk Lindner, University of Leipzig

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Leipzig, Sachsen, Germany, 04107
        • Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Titanium
Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit.
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.
Other Names:
  • CranioConstruct™
Experimental: Hydroxylapatite
Hydroxylapatite (CustomBone) implant Hydroxylapatite implants are used since about 3 years in Germany. As this material is very similar to human bone structure an improved osteointegration has been observed.
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.
Other Names:
  • CustomBone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms.
Time Frame: 6 months
6 months
Comparison of post-operative computer tomography (CT) (native and bone 5 mm) within 48 h in respect to bleeding, dislocation and further complications after cranioplasty in both arms.
Time Frame: 48 hours post-operative
48 hours post-operative
Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire.
Time Frame: 6 months
6 months
Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features.
Time Frame: 6 months
6 months
Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups.
Time Frame: 6 months
6 months
Description of osteointegration with CT and bone scan six months post-operative in both groups
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Universitätsklinikum Leipzig

Investigators

  • Study Director: Dirk Lindner, Dr. med., Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CustomBone vs. Titanium

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skull Defects

Clinical Trials on Titanium implant (CranioConstruct™)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe