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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

October 24, 2007
October 26, 2007
February 4, 2009
August 2005
November 2008   (Final data collection date for primary outcome measure)
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 ]
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).
Complete list of historical versions of study NCT00549627 on ClinicalTrials.gov Archive Site
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Evaluation of the PediGuard™ for Pedicle Screw Insertion
Evaluation of the PediGuard™ for Pedicle Screw Insertion

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Posterior Spinal Fusion
Device: Pediguard
PediGuard™ is a hand-held drilling tool that allows real-time detection of vertebral pedicle and body breaches in all directions.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
108
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December 2010
November 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00549627
4727
No
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Randal Betz, MD, Shriners Hospitals for Children
Shriners Hospitals for Children
Not Provided
Principal Investigator: Randal Betz, MD Shriners Hospitals for Children
Shriners Hospitals for Children
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP