Cranial Dysostosis Nec, Defect of Skull Ossification, Hemicraniectomy, Other Specified Skull or Face Bone Anomaly
Conditions
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 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.
Interventions
DEVICEOssDsign AB
Sponsors
Karolinska University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject mean MOCA | 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) |
| 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 | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health economy variables | 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. |
Countries
Sweden
Outcome results
None listed