Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction

Study Overview
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Brief Summary
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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.

Official Title
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Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series

Conditions
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Defect of Skull Ossification, Other Specified Skull or Face Bone Anomaly, Cranial Dysostosis Nec, Hemicraniectomy

Intervention / Treatment
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* Device: OssDsign AB


Participation Criteria
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Eligibility Criteria
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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. Exclusion criteria during surgery, if applicable: Perioperative appearance of previously not identified tumor or infection in the reconstruction area.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br> | Device: OssDsign AB<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |