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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Oulu University Hospital
Turku Clinical Biomaterials Centre
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01874613
First received: November 13, 2012
Last updated: February 18, 2015
Last verified: February 2015
  Purpose

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 Intervention
Cranial Bone Defect
Orbital Base Fracture
Device: FRC implant reconstruction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Functional outcome (a composition of following measures) [ Time Frame: 2 year follow-up ] [ Designated as safety issue: Yes ]

    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:
  • Aesthetic outcome (a composition of following measures) [ Time Frame: 2 years post-operatively ] [ Designated as safety issue: No ]

    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.



Enrollment: 19
Study Start Date: January 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01874613     History of Changes
Other Study ID Numbers: T97/2011
Study First Received: November 13, 2012
Last Updated: February 18, 2015
Health Authority: Finland: National Supervisory Authority for Welfare and Health

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

ClinicalTrials.gov processed this record on September 03, 2015