Evaluation of the PediGuard™ for Pedicle Screw Insertion

Shriners Hospitals for Children

Status: Suspended

Conditions: Posterior Spinal Fusion

Treatments: Device: Pediguard

Study type: Interventional

Funder types: Other

Identifiers

NCT00549627

4727

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Volunteers: No Healthy Volunteers

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
• 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.