Clinical Study of FRC Implant to Treat Skull Bone Defects
This trial is active, not recruiting.
|Conditions||cranial bone defect, orbital base fracture|
|Treatments||frc implant reconstruction|
|Sponsor||Turku University Hospital|
|Collaborator||Oulu University Hospital|
|Start date||January 2013|
|End date||December 2016|
|Trial size||19 participants|
|Trial identifier||NCT01874613, T97/2011|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Functional outcome (a composition of following measures)
time frame: 2 year follow-up
Aesthetic outcome (a composition of following measures)
time frame: 2 years post-operatively
Male or female participants of any age.
Inclusion Criteria: Study arm 1: - patients with skull bone defect - reconstruction indications fullfilled Study arm 2: - patients with orbital floor defect - reconstruction indication fullfilled Exclusion Criteria: - if informed consent cannot be obtained
|Official title||Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant|
|Principal investigator||Kalle J Aitasalo, Professor|
|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 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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