Evaluation of the PediGuard™ for Pedicle Screw Insertion
Public ClinicalTrials.gov record NCT00549627. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00549627
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2005 (Type not available)
- Primary completion
- Nov 2008 (Actual)
- Completion
- Dec 2010 (Estimated)
- Last update posted
- Feb 4, 2009
2005 – 2010
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Panorama Orthopedics and Spine Center | Golden | Colorado | 80401 | — |
| Miami Children's Hospital | Miami | Florida | — | — |
| University of Miami | Miami | Florida | — | — |
| Spine Institute | Louisville | Kentucky | 40202 | — |
| NYU Hospital for Joint Diseases | New York | New York | 10010 | — |
| Shriners Hospitals for Children | Philadelphia | Pennsylvania | 19140 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00549627, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2009 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00549627 live on ClinicalTrials.gov.