NCT00549627

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.

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

3.3 years

First QC Date

October 24, 2007

Last Update Submit

February 3, 2009

Conditions

Posterior Spinal Fusion

Outcome Measures

Primary Outcomes (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).

    Post-op CT prior to discharge

Interventions

PediguardDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Panorama Orthopedics and Spine Center

Golden, Colorado, 80401, United States

Location

Miami Children's Hospital

Miami, Florida, United States

Location

University of Miami

Miami, Florida, United States

Location

Spine Institute

Louisville, Kentucky, 40202, United States

Location

NYU Hospital for Joint Diseases

New York, New York, 10010, United States

Location

Shriners Hospitals for Children

Philadelphia, Pennsylvania, 19140, United States

Location

Victoria Hospital

London, Ontario, N6A4G5, Canada

Location

Study Officials

  • Randal Betz, MD

    Shriners Hospitals for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 26, 2007

Study Start

August 1, 2005

Primary Completion

November 1, 2008

Study Completion

December 1, 2010

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

CA(1)US(6)