Posterior Spinal Fusion Clinical Trial
Official title:
Evaluation of the PediGuard™ for Pedicle Screw Insertion
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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