Pedicle screw placement accuracy during spinal fixation surgery varies greatly and severe misplacement has been reported in 1-6.5 % of screws. Diffuse reflectance (DR) spectroscopy has previously been shown to reliably discriminate between tissues in the human body. We postulate that it could be used to discriminate between cancellous and cortical bone. Therefore, the purpose of this study is to validate DR spectroscopy as a warning system to detect impending pedicle screw breach in a cadaveric surgical setting using typical clinical breach scenarios. DR spectroscopy was incorporated at the tip of an integrated pedicle screw and screw driver used for tissue probing during pedicle screw insertions on six cadavers. Measurements were collected in the wavelength range of 400-1600 nm and each insertion was planned to result in a breach. Measurements were labelled as cancellous, cortical or representing a pre-cortical zone (PCZ) in between, based on information from cone beam computed tomographies at corresponding positions. In addition, DR spectroscopy data was recorded after breach. Four typical pedicle breach types were performed, and a total of 45 pedicle breaches were recorded. For each breach direction, the technology was able to detect the transition of the screw tip from the cancellous bone to the PCZ (P < 0.001), to cortical bone (P < 0.001), and to a subsequent breach (P < 0.001). Using support vector machine (SVM) classification, breach could reliably be detected with a sensitivity of 98.3 % [94.3-100 %] and a specificity of 97.7 % [91.0-100 %]. We conclude that DR spectroscopy reliably identifies the area of transition from cancellous to cortical bone in typical breach scenarios and can warn the surgeon of impending pedicle breach, thereby resulting in safer spinal fixation surgeries.

Safe and accurate placement of screws remains a critical issue in open and minimally invasive spine surgery. We propose to use diffuse reflectance (DR) spectroscopy as a sensing technology at the tip of a surgical instrument to ensure a safe path of the instrument through the cancellous bone of the vertebrae. This approach could potentially reduce the rate of cortical bone breaches, thereby resulting in fewer neural and vascular injuries during spinal fusion surgery. In our study, DR spectra in the wavelength ranges of 400 to 1600 nm were acquired from cancellous and cortical bone from three human cadavers. First, it was investigated whether these spectra can be used to distinguish between the two bone types based on fat, water, and blood content along with photon scattering. Subsequently, the penetration of the bone by an optical probe was simulated using the Monte-Carlo (MC) method, to study if the changes in fat content along the probe path would still enable distinction between the bone types. Finally, the simulation findings were validated via an experimental insertion of an optical screw probe into the vertebra aided by x-ray image guidance. The DR spectra indicate that the amount of fat, blood, and photon scattering is significantly higher in cancellous bone than in cortical bone (p < 0.01), which allows distinction between the bone types. The MC simulations showed a change in fat content more than 1 mm before the optical probe came in contact with the cortical bone. The experimental insertion of the optical screw probe gave similar results. This study shows that spectral tissue sensing, based on DR spectroscopy at the instrument tip, is a promising technology to identify the transition zone from cancellous to cortical vertebral bone. The technology therefore has the potential to improve the safety and accuracy of spinal screw placement procedures.

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Background: The safe and accurate placement of pedicle screws remains a critical step in open and minimally invasive spine surgery, emphasizing the need for intraoperative guidance techniques. Diffuse reflectance spectroscopy (DRS) is an optical sensing technology that may provide intraoperative guidance in pedicle screw placement. Purpose: The study presents the first in vivo minimally invasive procedure using DRS sensing at the tip of a Jamshidi needle with an integrated optical K-wire. We investigate the effect of tissue perfusion and probe-handling conditions on the reliability of fat fraction measurements for breach detection in vivo. Methods: A Jamshidi needle with an integrated fiber-optic K-wire was gradually inserted into the vertebrae under intraoperative image guidance. The fiber-optic K-wire consisted of two optical fibers with a fiber-to-fiber distance of 1.024 mm. DRS spectra in the wavelength range of 450 to 1600 nm were acquired at several positions along the path inside the vertebrae. Probe-handling conditions were varied by changing the amount of pressure exerted on the probe within the vertebrae. Continuous spectra were recorded as the probe was placed in the center of the vertebral body while the porcine specimen was sacrificed via a lethal injection. Results: A typical insertion of the fiber-optic K-wire showed a drop in fat fraction during an anterior breach as the probe transitioned from cancellous to cortical bone. Fat fraction measurements were found to be similar irrespective of the amount of pressure exerted on the probe (p = 0.65). The 95% confidence interval of fat fraction determination was found in the narrow range of 1.5-3.6% under various probe-handling conditions. The fat fraction measurements remained stable during 70 min of decreased blood flow after the animal was sacrificed. Discussions: These findings indicate that changes in tissue perfusion and probe-handling conditions have a relatively low measureable effect on the DRS signal quality and thereby on the determination of fat fraction as a breach detection signal. Conclusions: Fat fraction quantification for intraoperative pedicle screw breach detection is reliable, irrespective of changes in tissue perfusion and probe-handling conditions.