SpineGuard has announced that the anticipation of pedicle breaches using its FDA-cleared and CE-marked PediGuard device in a prospective clinical analysis of 50 patients with “rather rare and severe cervical spine disease” was 100% accurate in identifying an impassable cortical pedicle isthmus in 34 pedicles. The data was presented by principal investigator Heiko Koller, at the 5th Annual Meeting of CSRS-AP in Ho Chi Minh City, Vietnam.
In 34 pedicles a decision to stop pedicle screw tract preparation based on a signal from the PediGuard device that suggested an impassable cortical stimulus isthmus was later confirmed appropriate based on analysis of postoperative CT scans.
“We surgeons are constantly faced with difficult treatment planning for complex cervical deformities. By integrating the PediGuard device into surgery, we are able to provide our patients with greater construct stability, less neurological risk, and a better overall surgical outcome,” says Koller, Werner Wicker Klinik, Bad Wildungen, Germany.
Pedicle screws are the most common implant used in spinal surgery. Unfortunately, high rates of pedicle screw misplacements in the vertebra persist, which can lead to dramatic neurologic and vascular impairment. The scientific literature reveals that about 20% of pedicle screws are misplaced using conventional techniques, causing a 2% to 9% overall complication rate. Several published clinical studies in peer-reviewed medical journals have demonstrated the excellent pedicle screw placement accuracy of PediGuard.