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Clareo Health | Evaluation of the PediGuard™ for Pedicle Screw Insertion

Evaluation of the PediGuard™ for Pedicle Screw Insertion

NCT00549627·7 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

Shriners Hospitals for Children

Age

Any age

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible 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 be 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.

The record

StatusSuspended

PhaseNo phase

Taking part108

StartedAug 2005

UpdatedFeb 4, 2009

Conditions

Posterior Spinal Fusion

Where7

Panorama Orthopedics and Spine Center
Golden, Colorado, United States
Miami Children's Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States