Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction
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.
Defect of Skull Ossification
Other Specified Skull or Face Bone Anomaly
Cranial Dysostosis Nec
Device: OssDsign AB
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Rate of adverse events [ Time Frame: From the date of intervention up to 12 months post intervention ]The primary endpoint, rate of adverse events, will be measured by clinical evidence of infection and/or manifested rupture of skin around the implant, within 12 months, that necessitates explantation.
- 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 ]SF-12 and EQ5D 3L will be used
- 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 ]The bone tracer (18 F fluoride) will be used to measure bone regeneration.
- Subject mean MOCA [ Time Frame: 3 months and 12 months follow-up compared to baseline ]Subject cognitive impairment is measured by Montreal Cognitive Assessment (MOCA) (the subject will be given a score after completing the assessment)
- Health economy variables [ Time Frame: 3 months and 12 months post intervention compared to baseline visit: 3-0 weeks pre intervention ]Mean number of hospital days, hospital visits, mean time to adverse event and lost work days related to the study treatment will be counted.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01899807
|Dept. of Neurosurgery, Sahlgrenska University Hospital|
|Gothenburg, Sweden, 413 45|
|Dept. of Neurosurgery, Karolinska Universitetssjukhuset|
|Principal Investigator:||Lars Kihlström, MD, MBA||Department of Neurosurgery, Karolinska University Hospital|
|Principal Investigator:||Kalle Lundgren, MD, PhD||Karolinska University Hospital|