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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OssDsign AB | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events | 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. | From the date of intervention up to 12 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage subjects with an adverse event | From the date of intervention up to 14 days, 3 months, 6 months follow-up | |
| Quality of life scores | SF-12 and EQ5D 3L will be used | Assessed during the 3 month- and 12 month follow-up visit post intervention, compared to the screening visit: 3-0 weeks prior to intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Health economy variables | Mean number of hospital days, hospital visits, mean time to adverse event and lost work days related to the study treatment will be counted. | 3 months and 12 months post intervention compared to baseline visit: 3-0 weeks pre intervention |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria during surgery, if applicable:
Perioperative appearance of previously not identified tumor or infection in the reconstruction area.
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| Name | Affiliation | Role |
|---|---|---|
| Lars Kihlström, MD, MBA | Department of Neurosurgery, Karolinska University Hospital | Principal Investigator |
| Kalle Lundgren, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Neurosurgery, Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden | |||
| Dept. of Neurosurgery, Karolinska Universitetssjukhuset |
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| PET/CT analysis with bone tracer, confirms bone regeneration activity within the reconstruction area | The bone tracer (18 F fluoride) will be used to measure bone regeneration. | 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 | Subject cognitive impairment is measured by Montreal Cognitive Assessment (MOCA) (the subject will be given a score after completing the assessment) | 3 months and 12 months follow-up compared to baseline |
| Stockholm |
| Sweden |