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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Dept. of Neurosurgery, Sahlgrenska University Hospital
Gothenburg, Sweden
Dept. of Neurosurgery, Karolinska Universitetssjukhuset
Stockholm, Sweden
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.
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
SF-12 and EQ5D 3L will be used
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
The bone tracer (18 F fluoride) will be used to measure bone regeneration.
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
Subject cognitive impairment is measured by Montreal Cognitive Assessment (MOCA) (the subject will be given a score after completing the assessment)
Time frame: 3 months and 12 months follow-up compared to baseline
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