Clinical Study of FRC Implant to Treat Skull Bone Defects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant

Conditions
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Cranial Bone Defect, Orbital Base Fracture

Intervention / Treatment
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* Device: FRC implant reconstruction
* Device: FRC implant reconstruction


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skull bone reconstruction<br>Patients with skull bone defect | Device: FRC implant reconstruction<br>* A cranioplasty with the FRC implant is performed.<br>|
| Experimental: Orbital floor defect<br>Patients with orbital floor defect | Device: FRC implant reconstruction<br>* The orbital floor fracture is reconstructed with the FRC implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniofacial bone reconstruction, Fibre-reinforced composite, Bioactive glass, Craniotomy, Skull bone defect