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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
| Turku Clinical Biomaterials Centre | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skull bone reconstruction | Experimental | Patients with skull bone defect |
|
| Orbital floor defect | Experimental | Patients with orbital floor defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FRC implant reconstruction | Device | A cranioplasty with the FRC implant is performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome (a composition of following measures) | After reconstruction, patient follow-up protocol follows to assess functional outcome, including safety. Follow-up is done at timepoints of 1 week, 1 month, 3 months, 6 months and after that every 6 month up to 2 years post-operatively. After this the follow-up is continued yearly, if necessary. Visual and manual assessment is done by a doctor. Lateral and PA skull rtg is obtained to assess the fixation and position of the implant. C-reactive protein level and leukocyte level is measured to assess the possible inflammation. | 2 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic outcome (a composition of following measures) | After reconstruction, patient follow-up protocol follows to assess aesthetic outcome. Follow-up is done at timepoints of 1 week, 1 month, 3 months, 6 months and after that every 6 month up to 2 years post-operatively. After this the follow-up is continued yearly, if necessary. Visual and manual assessment is done by a doctor. Visual Analog Scale (VAS) is used by patient to assess
C-reactive protein level and leukocyte level is measured to assess the possible inflammation. |
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Inclusion Criteria:
Study arm 1:
Study arm 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kalle J Aitasalo, Professor | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology | Turku | N/A = Not Applicable | 20521 | Finland |
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| FRC implant reconstruction | Device | The orbital floor fracture is reconstructed with the FRC implant. |
|
| 2 years post-operatively |