NCT01899807UnknownNot Applicable
Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series
Karolinska University Hospital3 sites in 1 country11 target enrollmentStarted: June 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 11
- Locations
- 3
- Primary Endpoint
- Rate of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Obtained informed consent.
- •Males or females, ≥18 years of age
- •Subject with cranial defect size > 25 cm
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- 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)
- Percentage subjects with an adverse event(From the date of intervention up to 14 days, 3 months, 6 months follow-up)
- Subject mean MOCA(3 months and 12 months follow-up compared to baseline)
Investigators
Dr. Kalle Lundgren
MD, PhD
Karolinska University Hospital
Study Sites (3)
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