Status:
UNKNOWN
Clinical Study of FRC Implant to Treat Skull Bone Defects
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Oulu University Hospital
Turku Clinical Biomaterials Centre
Conditions:
Cranial Bone Defect
Orbital Base Fracture
Eligibility:
All Genders
Phase:
NA
Brief Summary
Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects and orbital floor defects. Functional and aesthetic outcome is assessed by patient and doctor.
Detailed Description
Development phase: Clinical trial Objectives: Assessment of functional and aesthetic outcome Methodology: Intervention study Sample size: 35+20+25 Main criteria for inclusion: Skull bone defect OR orb...
Eligibility Criteria
Inclusion
- Study arm 1:
- patients with skull bone defect
- reconstruction indications fullfilled
- Study arm 2:
- patients with orbital floor defect
- reconstruction indication fullfilled
Exclusion
- if informed consent cannot be obtained
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01874613
Start Date
January 1 2013
End Date
December 1 2019
Last Update
February 19 2015
Active Locations (1)
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1
Department of Otorhinolaryngology
Turku, N/A = Not Applicable, Finland, 20521