Status:
UNKNOWN
Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction
Lead Sponsor:
Karolinska University Hospital
Conditions:
Defect of Skull Ossification
Other Specified Skull or Face Bone Anomaly
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 probl...
Eligibility Criteria
Inclusion
- Obtained informed consent.
- Males or females, ≥18 years of age
- Subject with cranial defect size \> 25 cm2.
- History of previous cranial implant failure and where the latest cranial reconstruction failed within 12 months. (This means that the patient demonstrates a non-reconstructed cranial defect after removal of implant or exhibit an implant failure, e.g. local infection and/or protrusion through the skin.)
- Willing and able to comply with all study procedures and restrictions.
- The 5 subjects participating in bone regeneration analysis (PET/CT scans) has to be 50 years or older
Exclusion
- Malignancy adjacent to the reconstruction area, including brain and calvaria, with on-going or planned surgical intervention.
- Pregnant or nursing women.
- Exclusion criteria during surgery, if applicable:
- Perioperative appearance of previously not identified tumor or infection in the reconstruction area.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01899807
Start Date
June 1 2013
End Date
March 1 2016
Last Update
March 31 2015
Active Locations (2)
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1
Dept. of Neurosurgery, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
2
Dept. of Neurosurgery, Karolinska Universitetssjukhuset
Stockholm, Sweden