This trial is active, not recruiting.

Conditions cranial bone defect, orbital base fracture
Treatments frc implant reconstruction
Sponsor Turku University Hospital
Collaborator Oulu University Hospital
Start date January 2013
End date December 2016
Trial size 19 participants
Trial identifier NCT01874613, T97/2011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients with skull bone defect
frc implant reconstruction
A cranioplasty with the FRC implant is performed.
Patients with orbital floor defect
frc implant reconstruction
The orbital floor fracture is reconstructed with the FRC implant.

Primary Outcomes

Functional outcome (a composition of following measures)
time frame: 2 year follow-up

Secondary Outcomes

Aesthetic outcome (a composition of following measures)
time frame: 2 years post-operatively

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant
Principal investigator Kalle J Aitasalo, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Turku University Hospital.