Clinical Study of FRC Implant to Treat Skull Bone Defects
NCT ID: NCT01874613
Last Updated: 2015-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
19 participants
INTERVENTIONAL
2013-01-31
2019-12-31
Brief Summary
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Functional and aesthetic outcome is assessed by patient and doctor.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Skull bone reconstruction
Patients with skull bone defect
FRC implant reconstruction
A cranioplasty with the FRC implant is performed.
Orbital floor defect
Patients with orbital floor defect
FRC implant reconstruction
The orbital floor fracture is reconstructed with the FRC implant.
Interventions
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FRC implant reconstruction
A cranioplasty with the FRC implant is performed.
FRC implant reconstruction
The orbital floor fracture is reconstructed with the FRC implant.
Eligibility Criteria
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Inclusion Criteria
* patients with skull bone defect
* reconstruction indications fullfilled
Study arm 2:
* patients with orbital floor defect
* reconstruction indication fullfilled
Exclusion Criteria
ALL
No
Sponsors
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Oulu University Hospital
OTHER
Turku Clinical Biomaterials Centre
UNKNOWN
Turku University Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Kalle J Aitasalo, Professor
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Locations
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Department of Otorhinolaryngology
Turku, N/A = Not Applicable, Finland
Countries
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Other Identifiers
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T97/2011
Identifier Type: -
Identifier Source: org_study_id
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