Evaluation of the PediGuard™ for Pedicle Screw Insertion

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Conditions studied: Posterior Spinal Fusion

In brief

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.

Key facts

Study ID

NCT00549627

Run by

Shriners Hospitals for Children

People needed

108

Starts

2005-08-01

Expected to finish

2010-12-01

Last updated by the study team

2009-02-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• 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 — New York, New York, United States
• Shriners Hospitals for Children — Philadelphia, Pennsylvania, United States
• Victoria Hospital — London, Ontario, Canada

Full record on ClinicalTrials.gov

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