TerminatedPhase 3

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

Stopped: Recruitment was stopped, due to slow recruitment rate

Germany53 participantsStarted 2009-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Skull defects without the possibility to be covered with the missing own bone
✓. Size of the defect ≥ 16 cm2
✓. Age ≥ 18
✓. 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

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT00923793

SponsorUniversity of Leipzig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Skull Defects trials