Evaluation of the PediGuard™ for Pedicle Screw Insertion

February 3, 2009 updated by: Shriners Hospitals for Children

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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A4G5
        • Victoria Hospital
  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Panorama Orthopedics and Spine Center
    • Florida
      • Miami, Florida, United States
        • University of Miami
      • Miami, Florida, United States
        • Miami Children's Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Spine Institute
    • New York
      • NY, New York, United States, 10010
        • NYU Hospital for Joint Diseases
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Shriners Hospitals for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Post-op CT prior to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Investigators

  • Principal Investigator: Randal Betz, MD, Shriners Hospitals for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 24, 2007

First Posted (Estimate)

October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 4727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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