Trials / Unknown
UnknownNCT01899807
Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction
Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Karolinska University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi craniectomies. The frequency of infections and rupture of skin will be studied, which is a reoccurring problem with currently used bone graft substitutes in this subject population. In addition, the quality of life before and after implantation will be evaluated as well as the bone regeneration around implant.
Conditions
- Defect of Skull Ossification
- Other Specified Skull or Face Bone Anomaly
- Cranial Dysostosis Nec
- Hemicraniectomy
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OssDsign AB |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2013-07-15
- Last updated
- 2015-03-31
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01899807. Inclusion in this directory is not an endorsement.