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Evaluation of the PediGuard™ for Pedicle Screw Insertion

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ClinicalTrials.gov Identifier: NCT00549627
Recruitment Status : Suspended (New funding sources being sought)
First Posted : October 26, 2007
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:
Shriners Hospitals for Children

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.


Condition or disease Intervention/treatment Phase
Posterior Spinal Fusion Device: Pediguard Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluation of the PediGuard™ for Pedicle Screw Insertion
Study Start Date : August 2005
Actual Primary Completion Date : November 2008
Estimated Study Completion Date : December 2010

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


Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549627


Locations
United States, Colorado
Panorama Orthopedics and Spine Center
Golden, Colorado, United States, 80401
United States, Florida
Miami Children's Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
United States, Kentucky
Spine Institute
Louisville, Kentucky, United States, 40202
United States, New York
NYU Hospital for Joint Diseases
NY, New York, United States, 10010
United States, Pennsylvania
Shriners Hospitals for Children
Philadelphia, Pennsylvania, United States, 19140
Canada, Ontario
Victoria Hospital
London, Ontario, Canada, N6A4G5
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Randal Betz, MD Shriners Hospitals for Children

Responsible Party: Randal Betz, MD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00549627     History of Changes
Other Study ID Numbers: 4727
First Posted: October 26, 2007    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009