Cranial Bone Defect Clinical Trial
— Cranio-2Official 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.
| Status | Active, not recruiting |
| Enrollment | 19 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Finland | Department of Otorhinolaryngology | Turku | N/A = Not Applicable |
| Lead Sponsor | Collaborator |
|---|---|
| Turku University Hospital | Oulu University Hospital, Turku Clinical Biomaterials Centre |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 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. |
2 years post-operatively | No |