NCT01874613

Clinical Study of FRC Implant to Treat Skull Bone Defects

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cranial Bone Defect
• Orbital Base Fracture

Interventions

Type	Name	Description
DEVICE	FRC implant reconstruction	A cranioplasty with the FRC implant is performed.
DEVICE	FRC implant reconstruction	The orbital floor fracture is reconstructed with the FRC implant.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-12-01
• Completion: 2019-12-01
• First posted: 2013-06-11
• Last updated: 2015-02-19

Locations

1 site across 1 country: Finland