Posterior Spinal FusionNCT00549627
Evaluation of the PediGuard™ for Pedicle Screw Insertion
A study testing Pediguard in people with Posterior Spinal Fusion, run by Shriners Hospitals for Children at 7 sites in 2 countries.
Trial summary
The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the spine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Posterior Spinal Fusion
- What is being tested?
- Pediguard
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Aug 2005to Dec 2010
- 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
- Patients undergoing primary spinal fusion with pedicle screw fixation of the spine anywhere from T1to S1
- Subjects must be skeletally mature as defined by closed growth plates on wrist via radiographs
- Written informed consent and assent (assent for adolescents)
Who cannot join
- Pedicle screw insertion by image guided techniques, including Fluoronav
- Tumor
- Diagnoses associated with diminished bone mineral density such as osteogenesis imperfecta, severe osteopenia, neurofibromatosis
- Severe senile osteoporosis (> 2 standard deviations below the norm)
- Women who are pregnant
- Children with open growth plates
- Previously fused spinal levels
- Unwillingness to sign written informed consent and assent.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Panorama Orthopedics and Spine Center
Golden, Colorado, 80401
Spine Institute
Louisville, Kentucky, 40202
Miami Children's Hospital
Miami, Florida
University of Miami
Miami, Florida
NYU Hospital for Joint Diseases
New York, New York, 10010
Shriners Hospitals for Children
Philadelphia, Pennsylvania, 19140
About this study
The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the spine.
Hypothesis #1 The PediGuardTM will be more accurate for pedicle screw placement as compared to other standard manual techniques of similar size of pedicle screw insertion. At least 90% of screws placed with the PediGuardTM will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan). In contrast, only 80% of screws using manual placement will be positioned correctly in the pedicle.
Hypothesis #2 The PediGuardTM will not be inferior to fluoroscopic techniques for pedicle screw insertion. Both techniques will achieve at least 90% accuracy in the placement of pedicle screws.
- Conditions
- Posterior Spinal Fusion
- Being tested
- Pediguard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PediguardDevice
PediGuard™ is a hand-held drilling tool that allows real-time detection of vertebral pedicle and body breaches in all directions.
What is being measured
The primary outcome is the main question the study is designed to answer.
At least 90% of screws placed with the PediGuard™ will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan).
Measured: Post-op CT prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startAug 2005
- Primary completionNov 2008
- Study completionDec 2010 (estimated)
Why it stopped: New funding sources being sought
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Spinal FusionStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Investigators
- Randal Betz, MD, Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549627
- Sponsor's protocol ID
- 4727
- Status last verified
- Feb 2009
- First submitted
- 24 Oct 2007
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PediGuard™ for Pedicle Screw Insertion
- ClinicalTrials.gov ID
- NCT00549627
- Acronym / sponsor ID
- 4727
- Conditions
- Posterior Spinal Fusion
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: New funding sources being sought
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 26 Oct 2007 (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 aim of the study is to determine the relative effectiveness of the PediGuardTM , a device manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the spine.
Hypothesis #1 The PediGuardTM will be more accurate for pedicle screw placement as compared to other standard manual techniques of similar size of pedicle screw insertion. At least 90% of screws placed with the PediGuardTM will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan). In contrast, only 80% of screws using manual placement will be positioned correctly in the pedicle.
Hypothesis #2 The PediGuardTM will not be inferior to fluoroscopic techniques for pedicle screw insertion. Both techniques will achieve at least 90% accuracy in the placement of pedicle screws.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing primary spinal fusion with pedicle screw fixation of the spine anywhere from T1to S1
- Subjects must be skeletally mature as defined by closed growth plates on wrist via radiographs
- Written informed consent and assent (assent for adolescents)
Key exclusion criteria (8 listed)
- Pedicle screw insertion by image guided techniques, including Fluoronav
- Tumor
- Diagnoses associated with diminished bone mineral density such as osteogenesis imperfecta, severe osteopenia, neurofibromatosis
- Severe senile osteoporosis (> 2 standard deviations below the norm)
- Women who are pregnant
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 |
|---|---|---|
| PediguardPediGuard™ is a hand-held drilling tool that allows real-time detection of vertebral pedicle and body breaches in all directions. | Device | – |
Primary outcome
At least 90% of screws placed with the PediGuard™ will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan).
Time frame: Post-op CT prior to discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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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.
Randal Betz, MD principal investigator
Shriners Hospitals for Children
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediguard in people with Posterior Spinal Fusion, run by Shriners Hospitals for Children at 7 sites in 2 countries.
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 3 inclusion and 8 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: paused, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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?
At least 90% of screws placed with the PediGuard™ will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan). (time frame: Post-op CT prior to discharge). 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 4 Feb 2009.