Clinical Study of FRC Implant to Treat Skull Bone Defects (Cranio-2)

Turku University Hospital (TYKS)

Status: Unknown

Conditions: Cranial Bone Defect; Orbital Base Fracture

Treatments: Device: FRC implant reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01874613

T97/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Skull bone reconstruction

Experimental group

Description:

Patients with skull bone defect

Treatment:

Device: FRC implant reconstruction

Device: FRC implant reconstruction

Orbital floor defect

Experimental group

Description:

Patients with orbital floor defect

Treatment:

Device: FRC implant reconstruction

Device: FRC implant reconstruction