Cranial Bone DefectCranio-2NCT01874613
Clinical Study of FRC Implant to Treat Skull Bone Defects
A study testing FRC implant reconstruction in people with Cranial Bone Defect and Orbital Base Fracture, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cranial Bone Defect, Orbital Base Fracture
- What is being tested?
- FRC implant reconstruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2013to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Study arm 1:
- patients with skull bone defect
- reconstruction indications fullfilled
- Study arm 2:
- patients with orbital floor defect
- reconstruction indication fullfilled
Who cannot join
- if informed consent cannot be obtained
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Otorhinolaryngology
Turku, N/A = Not Applicable, 20521
About this study
Official title: 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.
Read the 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
- Being tested
- FRC implant reconstruction
- Keywords
- Craniofacial bone reconstruction, Fibre-reinforced composite, Bioactive glass, Craniotomy, Skull bone defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRC implant reconstructionDevice
A cranioplasty with the FRC implant is performed.
FRC implant reconstructionDevice
The orbital floor fracture is reconstructed with the FRC implant.
| Study group | Role | What they receive |
|---|---|---|
| Skull bone reconstruction | Experimental | Patients with skull bone defect Receives: Device: FRC implant reconstruction |
| Orbital floor defect | Experimental | Patients with orbital floor defect Receives: Device: FRC implant reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome (a composition of following measures)
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.
Measured: 2 year follow-up
Secondary outcomes (1)
Aesthetic outcome (a composition of following measures)
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.
Measured: 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial Bone DefectStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Oulu University Hospital, Turku Clinical Biomaterials Centre
- Responsible party
- Sponsor
- Investigators
- Kalle J Aitasalo, Professor, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874613
- Sponsor's protocol ID
- T97/2011
- Acronym
- Cranio-2
- Status last verified
- Feb 2015
- First submitted
- 13 Nov 2012
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Skull Defect Reconstruction With Patient-specific Fibre-reinforced Composite Implant
- ClinicalTrials.gov ID
- NCT01874613
- Acronym / sponsor ID
- Cranio-2 / T97/2011
- Conditions
- Cranial Bone Defect, Orbital Base Fracture
- Keywords
- Craniofacial bone reconstruction, Fibre-reinforced composite, Bioactive glass, Craniotomy, Skull bone defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Oulu University Hospital, Turku Clinical Biomaterials Centre
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skull bone reconstruction | Experimental | Device: FRC implant reconstructionPatients with skull bone defect |
| Orbital floor defect | Experimental | Device: FRC implant reconstructionPatients with orbital floor defect |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients with skull bone defect
- reconstruction indications fullfilled
- patients with orbital floor defect
- reconstruction indication fullfilled
Key exclusion criteria (1 listed)
- if informed consent cannot be obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRC implant reconstructionA cranioplasty with the FRC implant is performed. | Device | Skull bone reconstruction |
| FRC implant reconstructionThe orbital floor fracture is reconstructed with the FRC implant. | Device | Orbital floor defect |
Primary outcome
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.
1 secondary outcome
Aesthetic outcome (a composition of following measures)
Time frame: 2 years post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalle J Aitasalo, Professor principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRC implant reconstruction in people with Cranial Bone Defect and Orbital Base Fracture, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (a composition of following measures) (time frame: 2 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.