Evaluation of the PediGuard™ for Pedicle Screw Insertion

Posterior Spinal Fusion Clinical Trial

Official title:

Evaluation of the PediGuard™ for Pedicle Screw Insertion

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00549627
• Other study ID #: 4727
• Status: Suspended
• Phase: N/A
• First received: October 24, 2007
• Last updated: February 3, 2009
• Start date: August 2005
• Est. completion date: December 2010

Study information

• Verified date: February 2009
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 108
• Est. completion date: December 2010
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Posterior Spinal Fusion

Intervention

Device:
• Pediguard
PediGuard™ is a hand-held drilling tool that allows real-time detection of vertebral pedicle and body breaches in all directions.

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario
United States	Panorama Orthopedics and Spine Center	Golden	Colorado
United States	Spine Institute	Louisville	Kentucky
United States	Miami Children's Hospital	Miami	Florida
United States	University of Miami	Miami	Florida
United States	NYU Hospital for Joint Diseases	NY	New York
United States	Shriners Hospitals for Children	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes