Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction
This trial is active, not recruiting.
|Conditions||defect of skull ossification, other specified skull or face bone anomaly, cranial dysostosis nec, hemicraniectomy|
|Sponsor||Karolinska University Hospital|
|Start date||June 2013|
|End date||March 2016|
|Trial size||11 participants|
|Trial identifier||NCT01899807, OQ-CR-001|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||single group assignment|
Rate of adverse events
time frame: From the date of intervention up to 12 months post intervention
Percentage subjects with an adverse event
time frame: From the date of intervention up to 14 days, 3 months, 6 months follow-up
Quality of life scores
time frame: Assessed during the 3 month- and 12 month follow-up visit post intervention, compared to the screening visit: 3-0 weeks prior to intervention
PET/CT analysis with bone tracer, confirms bone regeneration activity within the reconstruction area
time frame: The PET/CT scan will be taken at 12 months post intervention and it will be compared with 2 weeks post intervention
Subject mean MOCA
time frame: 3 months and 12 months follow-up compared to baseline
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Criteria: - 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.
|Official title||Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series|
|Principal investigator||Lars Kihlström, MD, MBA|
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