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Recruitment was stopped, due to slow recruitment rate
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| Name | Class |
|---|---|
| Universitätsklinikum Leipzig | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titanium | Active Comparator | Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit. |
|
| Hydroxylapatite | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titanium implant (CranioConstruct™) | Device | One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered. |
| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Lindner, Dr. med. | Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie | Leipzig | Saxony | 04107 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Eufinger H, Weihe S, Scherer P, Rasche C, Wehmöller M. Management of cranial and craniofacial bone defects with prefabricated individual titanium implants: follow-up and evaluation of 166 patients with 169 titanium implants from 1994 to 2000. Int. J. CARS 2006; 1: 197-203 | ||
| 26918471 | Derived | Lindner D, Schlothofer-Schumann K, Kern BC, Marx O, Muns A, Meixensberger J. Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial. J Neurosurg. 2017 Jan;126(1):175-183. doi: 10.3171/2015.10.JNS151245. Epub 2016 Feb 26. |
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| Hydroxylapatite (CustomBone) | Device | Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered. |
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| 48 hours post-operative |
| Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire. | 6 months |
| 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 |