Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction
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|ClinicalTrials.gov Identifier: NCT01899807|
Recruitment Status : Unknown
Verified March 2015 by Dr. Kalle Lundgren, Karolinska University Hospital.
Recruitment status was: Active, not recruiting
First Posted : July 15, 2013
Last Update Posted : March 31, 2015
|Condition or disease||Intervention/treatment||Phase|
|Defect of Skull Ossification Other Specified Skull or Face Bone Anomaly Cranial Dysostosis Nec Hemicraniectomy||Device: OssDsign AB||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
|Single Arm||Device: OssDsign AB|
- 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.
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): 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|