Surgical Procedure, UnspecifiedPhase 3FLUORONAVNCT01335841
Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis
A Phase 3 study testing Navigation station coupled with a 3D fluoroscopy in people with Surgical Procedure, Unspecified, run by AdministrateurCIC at 1 site in France.
Trial summary
The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Navigation station coupled with a 3D fluoroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Jul 2012
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged over 18 years old
- Patient affiliated to social security or similarly regime
- Patient with a disease of the pelvic ring, with an indication of establishment of a screw sacro-iliac
- Patient with a disease of the spine, with an indication of establishment of pedicle implant
Who cannot join
- Intubated patient resuscitation
- Pregnant women and lactating mothers
- Adult unable to express their consent
- Ward of court or under guardianship
- Person under legal protection
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
Grenoble
About this study
The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Navigation station coupled with a 3D fluoroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation station coupled with a 3D fluoroscopyDevice
After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.
| Study group | Role | What they receive |
|---|---|---|
| 3D fluoroscopy and navigation station | Experimental | Not described Receives: Device: Navigation station coupled with a 3D fluoroscopy |
| 2D and anatomical landmarks | Active comparator | Not described Receives: Device: Navigation station coupled with a 3D fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM
Measured: two years
Secondary outcomes (2)
measure radiation of the surgeon and the patient in the two groups
delivered dose and irradiation time during the duration of the intervention for the sacro-iliac screw connections, or for the establishment of two pedicle screws in spinal surgery over a 2-D amplifier
Measured: two years
Show that the operative time is not increased significantly taking into account the learning curve and the benefit provided from a conventional 2-D amplifier
comparison of operating times of interventions between "3D-navigation" and conventional methods
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurCIC
- Sponsor type
- University, hospital or other
- Collaborators
- PRAXIM company
- Responsible party
- Sponsor-investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Philippe Merloz, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335841
- Sponsor's protocol ID
- DCIC-10 25
- Acronym
- FLUORONAV
- Status last verified
- Jan 2013
- First submitted
- 31 Jan 2011
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis
- ClinicalTrials.gov ID
- NCT01335841
- Acronym / sponsor ID
- FLUORONAV / DCIC-10 25
- Conditions
- Surgical Procedure, Unspecified
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AdministrateurCICUniversity, hospital or other
- Collaborators
- PRAXIM company
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Apr 2011 (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.
The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D fluoroscopy and navigation station | Experimental | Device: Navigation station coupled with a 3D fluoroscopy |
| 2D and anatomical landmarks | Active comparator | Device: Navigation station coupled with a 3D fluoroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged over 18 years old
- Patient affiliated to social security or similarly regime
- Patient with a disease of the pelvic ring, with an indication of establishment of a screw sacro-iliac
- Patient with a disease of the spine, with an indication of establishment of pedicle implant
Key exclusion criteria (7 listed)
- Intubated patient resuscitation
- Pregnant women and lactating mothers
- Adult unable to express their consent
- Ward of court or under guardianship
- Person under legal protection
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 |
|---|---|---|
| Navigation station coupled with a 3D fluoroscopyAfter randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants. | Device | 2D and anatomical landmarks, 3D fluoroscopy and navigation station |
Primary outcome
Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM
Time frame: two years
2 secondary outcomes
measure radiation of the surgeon and the patient in the two groups
Time frame: two years
Show that the operative time is not increased significantly taking into account the learning curve and the benefit provided from a conventional 2-D amplifier
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
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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.
Philippe Merloz, Pr principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Navigation station coupled with a 3D fluoroscopy in people with Surgical Procedure, Unspecified, run by AdministrateurCIC at 1 site in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 25 Jan 2013. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM (time frame: two years). 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 25 Jan 2013.