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Evaluation of the PediGuard™ for Pedicle Screw Insertion

This study has suspended participant recruitment.
(New funding sources being sought)
Sponsor:
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00549627
First received: October 24, 2007
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention
Posterior Spinal Fusion
 Device: Pediguard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of the PediGuard™ for Pedicle Screw Insertion

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 108
Study Start Date: August 2005
Estimated Study Completion Date: December 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Randal Betz, MD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00549627     History of Changes
Other Study ID Numbers: 4727
Study First Received: October 24, 2007
Last Updated: February 3, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013