Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty
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|ClinicalTrials.gov Identifier: NCT00923793|
Recruitment Status : Terminated (Recruitment was stopped, due to slow recruitment rate)
First Posted : June 18, 2009
Last Update Posted : May 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Skull Defects Cranioplasty||Device: Titanium implant (CranioConstruct™) Device: Hydroxylapatite (CustomBone)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: Titanium
Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit.
Device: Titanium 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.
Other Name: CranioConstruct™
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.
Device: Hydroxylapatite (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.
Other Name: CustomBone
- 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 ]
- Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms. [ Time Frame: 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. [ Time Frame: 48 hours post-operative ]
- Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire. [ Time Frame: 6 months ]
- Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features. [ Time Frame: 6 months ]
- Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups. [ Time Frame: 6 months ]
- Description of osteointegration with CT and bone scan six months post-operative in both groups [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923793
|Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie|
|Leipzig, Sachsen, Germany, 04107|
|Study Director:||Dirk Lindner, Dr. med.||Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie|