Cranial Bone Defect, Orbital Base Fracture
Conditions
Keywords
Craniofacial bone reconstruction, Fibre-reinforced composite, Bioactive glass, Craniotomy, Skull bone defect
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 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.
Interventions
DEVICEFRC implant reconstruction
A cranioplasty with the FRC implant is performed.
Sponsors
Oulu University Hospital
Turku Clinical Biomaterials Centre
Turku University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome (a composition of following measures) | 2 year follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic outcome (a composition of following measures) | 2 years post-operatively | 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 * functional outcome * aesthetic outcome * pain 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. |
Countries
Finland
Outcome results
None listed