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

University of Leipzig

Status and phase: Terminated; Phase 3

Conditions: Cranioplasty; Skull Defects

Treatments: Device: Titanium implant (CranioConstruct™); Device: Hydroxylapatite (CustomBone)

Study type: Interventional

Funder types: Other

Identifiers

NCT00923793

CustomBone vs. Titanium

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Titanium

Active Comparator group

Description:

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

Treatment:

Device: Titanium implant (CranioConstruct™)

Hydroxylapatite

Experimental group

Description:

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.

Treatment:

Device: Hydroxylapatite (CustomBone)