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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Skull Defects Cranioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Titanium

Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit.

Group Type ACTIVE_COMPARATOR

Titanium implant (CranioConstruct™)

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Hydroxylapatite (CustomBone)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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CranioConstruct™ CustomBone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No