Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial

University of Leipzig1 site in 1 country53 target enrollmentJune 2009

ConditionsSkull Defects Cranioplasty

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Skull Defects
Sponsor: University of Leipzig
Enrollment: 53
Locations: 1
Primary Endpoint: Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

April 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Leipzig

Responsible Party

Principal Investigator

Dirk Lindner

Dr.

University of Leipzig

Eligibility Criteria

Inclusion Criteria

•Skull defects without the possibility to be covered with the missing own bone
•Size of the defect ≥ 16 cm2
•Written informed consent of the patient

Exclusion Criteria

•Active tumor
•ASA 4 classification
•Allergic disposition to ceramic or titanium
•Concomitant participation in other clinical trials
•Pregnant or nursing women
•Expected low compliance
•HIV positive
•Active drug abuses

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)