Evaluation of the PediGuard™ for Pedicle Screw Insertion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Enrollment
- 108
- Locations
- 12
- Primary Endpoint
- 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).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •Pedicle screw insertion by image guided techniques, including Fluoronav
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported