Evaluation of the PediGuard™ for Pedicle Screw Insertion

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00549627

Enrollment

108

Registered

2007-10-26

Start date

2005-08-31

Completion date

2010-12-31

Last updated

2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Spinal Fusion

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.

Interventions

DEVICEPediguard

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026