Cranioplasty, Skull Defects
Conditions
Keywords
skull defects, Hydroxylapatite implant, Titanium implant, calotte defects without the possibility to be covered with the missing own bone
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.
Interventions
DEVICETitanium 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.
DEVICEHydroxylapatite (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.
Sponsors
Universitätsklinikum Leipzig
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups. | 6 months |
| Description of osteointegration with CT and bone scan six months post-operative in both groups | 6 months |
| Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire. | 6 months |
Countries
Germany
Outcome results
None listed