Independent assessment of a new pedicle probe and its ability to detect pedicle breach: A cadaveric study - Laboratory investigation

Abstract

Object. The authors undertook an independent, non-industry funded cadaveric study to evaluate the efficacy of a pedicle-probing device, which uses impedance measurement to warn of impending and actual pedicle screw breach. Methods. A previously validated fresh-frozen cadaver model (saline-soaked spine) was used. Individuals at 3 levels of training (attending spine surgeon, orthopedic surgery resident, and medical student) used a cannulated pedicle-probing device to cannulate each of the levels between T-2 and S-1. Each pedicle was cannulated freehand using 2 approaches: 1) a standard trajectory through the middle of the pedicle, and 2) a medial trajectory aimed to breach the medial wall of the pedicle. A 16-slice helical CT scanner was used. The images were interpreted and analyzed by 2 orthopedic spine surgeons and a neuroradiologist. Results. The sensitivity of the pedicle probe to detect impending breach or breach of 4 mm or less was 90.06%. The sensitivity in detecting medial wall breach was 95.8%. The positive predictive value was 87.1%. The device detected medial breach more often than lateral breach. Conclusions. This study showed that this pedicle-probing device could reasonably be used to detect impending breach and actual breach of 4 mm or less. Medial breach was detected better than lateral breach. Use of the pedicle probe may improve patient safety.