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

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ClinicalTrials.gov Identifier: NCT01874613
Recruitment Status : Active, not recruiting
First Posted : June 11, 2013
Last Update Posted : February 19, 2015
Sponsor:
Collaborators:
Oulu University Hospital
Turku Clinical Biomaterials Centre
Information provided by (Responsible Party):
Turku University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cranial Bone Defect Orbital Base Fracture Device: FRC implant reconstruction Not Applicable

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  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant
Study Start Date : January 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Skull bone reconstruction
Patients with skull bone defect
Device: FRC implant reconstruction
A cranioplasty with the FRC implant is performed.

Experimental: Orbital floor defect
Patients with orbital floor defect
Device: FRC implant reconstruction
The orbital floor fracture is reconstructed with the FRC implant.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874613


Locations
Finland
Department of Otorhinolaryngology
Turku, N/A = Not Applicable, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Oulu University Hospital
Turku Clinical Biomaterials Centre
Investigators
Principal Investigator: Kalle J Aitasalo, Professor Turku University Hospital

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01874613     History of Changes
Other Study ID Numbers: T97/2011
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015

Keywords provided by Turku University Hospital:
Craniofacial bone reconstruction
Fibre-reinforced composite
Bioactive glass
Craniotomy
Skull bone defect