Cranial Bone Defect Clinical Trial
Official title:
Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant
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.
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 orbital floor fracture
Investigational drug/treatment, dose and mode of administration: FRC implant Comparative
drug(s)/placebo/treatment, dose and mode of administration: -
Duration of treatment: 2 years of follow-up
Assessments:
Clinical outcome and radiologic assesment Functional and aesthetic outcome with Visual
Analog Scale (VAS). Pain assessment with VAS.
Statistical methods:
Adequate statistical methods for publishing in international peer-reviewed journals.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment