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

February 18, 2015 updated by: Turku University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • N/A = Not Applicable
      • Turku, N/A = Not Applicable, Finland, 20521
        • Department of Otorhinolaryngology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skull bone reconstruction
Patients with skull bone defect
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.
Experimental: Orbital floor defect
Patients with orbital floor defect
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome (a composition of following measures)
Time Frame: 2 year follow-up

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)
Time Frame: 2 years post-operatively

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Oulu University Hospital
Turku Clinical Biomaterials Centre

Investigators

  • Principal Investigator: Kalle J Aitasalo, Professor, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • T97/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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