Objective: The purpose of this study is to report the results using PediGuard (electrical conductivity device) to reduce radiation exposure while drilling the pilot hole for pedicle screw placement. Method: Eighteen patients diagnosed with a degenerative lumbar spine, that required a posterior spinal fusion. Average age of the patients were 55 ± 12 years. Patients received postoperative CT scans of all screws. Scans were reviewed by an independent reviewer grading 'in' < 2 mm of breach , or 'out' > 2 mm of breach. In a randomized fashion, the surgeon created pilot holes with either his standard technique or by using the PediGuard. Fluoroscopy was used for each drilling as necessary. Once the pilot hole was created, the surgeon inserted titanium screws into the pedicle pilot holes. A total of 78 screws (39 standard probe and 39 PediGuard ) were analyzed. Results: 78 screws (39 standard probe and 39 PediGuard were analyzed. No significant difference in breach rate > 2mm by either method (p=1.000), with one screw out in each group. Fluoroscopy shots averaged 5.2 (range, 0 to 15), average decrease of 2.3 (30%) per screw in the PediGuard group vs. 7.5 (range, 2 to 17) in the standard group (p< .001). Conclusion: This trial to assess pedicle probe location within the pedicle and vertebral body showed the number of fluoroscopy shots were reduced by 30%, compared to a standard probe while maintaining a 97.5% screw placement accuracy.
Objective: The purpose of this study is to report the results using PediGuard (electrical conductivity device) to reduce radiation exposure while drilling the pilot hole for pedicle screw placement. Method: Eighteen patients diagnosed with a degenerative lumbar spine, that required a posterior spinal fusion. Average age of the patients were 55 ± 12 years. Patients received postoperative CT scans of all screws. Scans were reviewed by an independent reviewer grading 'in' < 2 mm of breach , or 'out' > 2 mm of breach. In a randomized fashion, the surgeon created pilot holes with either his standard technique or by using the PediGuard. Fluoroscopy was used for each drilling as necessary. Once the pilot hole was created, the surgeon inserted titanium screws into the pedicle pilot holes. A total of 78 screws (39 standard probe and 39 PediGuard ) were analyzed. Results: 78 screws (39 standard probe and 39 PediGuard were analyzed. No significant difference in breach rate > 2mm by either method (p=1.000), with one screw out in each group. Fluoroscopy shots averaged 5.2 (range, 0 to 15), average decrease of 2.3 (30%) per screw in the PediGuard group vs. 7.5 (range, 2 to 17) in the standard group (p< .001). Conclusion: This trial to assess pedicle probe location within the pedicle and vertebral body showed the number of fluoroscopy shots were reduced by 30%, compared to a standard probe while maintaining a 97.5% screw placement accuracy.
OBJECTIVE: To determine the effectiveness of a pedicle probe to anticipate an impending breach and allow redirection during placement of a pilot pedicle hole. METHODS: Purposely four cortical wall sites were drilled: medial and lateral pedicle wall, and lateral and anterior wall of the vertebral body. The surgeon stopped probing when the sound changed, suggesting abutment against the cortical wall ("anticipation" of impending breach). A fluoroscopy image was then obtained. The surgeon then advanced the PediGuard through the cortex until the sound changed, indicating a breach. In the second part of the study three probes were used: 1) DSG (PediGuard) with curved tip with electronics ON; 2) DSG with electronics OFF; 3) standard Lenke probe. After the images were taken, the operating surgeon (blinded to x-rays) was instructed to redirect and continue drilling into the vertebral body. RESULTS: The surgeon accurately anticipated 60 of 75 (80%) of the breaches, 17 of 19 (89%) in the medial pedicle wall. In the second part of the study the DSG with electronics ON was superior to the DSG with electronics OFF as well as the standard Lenke probe (100% vs. 90% vs. 79%, p = 0.0191). CONCLUSION: Successful redirection by passing the pedicle probes into the vertebral body without a breach after anticipation of an impending pedicle wall breach occurred in 100% of the drillings when done with the DSG with the electronics ON vs only 84% when there was no electronic feedback.
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