NCT00549627

Evaluation of the PediGuard™ for Pedicle Screw Insertion

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Shriners Hospitals for Children · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Posterior Spinal Fusion

Interventions

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

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-11-01
• Completion: 2010-12-01
• First posted: 2007-10-26
• Last updated: 2009-02-04

Locations

7 sites across 2 countries: United States, Canada