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

Phase 3

Terminated

• Conditions: Cranioplasty; Skull Defects
• Interventions: Device: Hydroxylapatite (CustomBone); Device: Titanium implant (CranioConstruct™)

• Registration Number: NCT00923793
• Lead Sponsor: University of Leipzig

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-operations, antibiotic treatment or removal of the implant.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxylapatite	Hydroxylapatite (CustomBone)	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.
Titanium	Titanium implant (CranioConstruct™)	Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire.	6 months
Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups.	6 months
Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms.	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.	48 hours post-operative
Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features.	6 months
Description of osteointegration with CT and bone scan six months post-operative in both groups	6 months

Trial Locations

Locations (1)

Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie; 🇩🇪 Leipzig, Sachsen, Germany