Evaluation of the PediGuard™ for Pedicle Screw Insertion
- Conditions
- Posterior Spinal Fusion
- Registration Number
- NCT00549627
- Lead Sponsor
- Shriners Hospitals for Children
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 108
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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). Post-op CT prior to discharge
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Panorama Orthopedics and Spine Center
🇺🇸Golden, Colorado, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Spine Institute
🇺🇸Louisville, Kentucky, United States
NYU Hospital for Joint Diseases
🇺🇸NY, New York, United States
Shriners Hospitals for Children
🇺🇸Philadelphia, Pennsylvania, United States
Victoria Hospital
🇨🇦London, Ontario, Canada
Panorama Orthopedics and Spine Center🇺🇸Golden, Colorado, United States