Evaluation of the PediGuard™ for Pedicle Screw Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Posterior Spinal Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Pediguard

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No