Independent assessment of a new pedicle probe and its ability to detect pedicle breach: a cadaveric study
Laboratory investigation
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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.
Abbreviation used in this paper:
PPV = positive predictive value.
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