Ultrasound-based navigated pedicle screw insertion without intraoperative radiation: feasibility study on porcine cadavers.

Background: Navigation systems for spinal fusion surgery rely on intraoperative computed tomography (CT) or fluoroscopy imaging. Both expose patient, surgeons and operating room staff to significant amounts of radiation. Alternative methods involving intraoperative ultrasound (iUS) imaging have recently shown promise for image-to-patient registration. Yet, the feasibility and safety of iUS navigation in spinal fusion have not been demonstrated.

Purpose: To evaluate the accuracy of pedicle screw insertion in lumbar and thoracolumbar spinal fusion using a fully automated iUS navigation system.

Study Design: Prospective porcine cadaver study.

Methods: Five porcine cadavers were used to instrument the lumbar and thoracolumbar spine using posterior open surgery. During the procedure, iUS images were acquired and used to establish automatic registration between the anatomy and preoperative CT images. Navigation was performed with the preoperative CT using tracked instruments. The accuracy of the system was measured as the distance of manually collected points to the preoperative CT vertebral surface and compared against fiducial-based registration. A postoperative CT was acquired, and screw placements were manually verified. We report breach rates, as well as axial and sagittal screw deviations.

Results: A total of 56 screws were inserted (5.50 mm diameter n=50, and 6.50 mm diameter n=6). Fifty-two screws were inserted safely without breach. Four screws (7.14%) presented a medial breach with an average deviation of 1.35±0.37 mm (all <2 mm). Two breaches were caused by 6.50 mm diameter screws, and two by 5.50 mm screws. For vertebrae instrumented with 5.50 mm screws, the average axial diameter of the pedicle was 9.29 mm leaving a 1.89 mm margin in the left and right pedicle. For vertebrae instrumented with 6.50 mm screws, the average axial diameter of the pedicle was 8.99 mm leaving a 1.24 mm error margin in the left and right pedicle. The average distance to the vertebral surface was 0.96 mm using iUS registration and 0.97 mm using fiducial-based registration.

Conclusions: We successfully implanted all pedicle screws in the thoracolumbar spine using the ultrasound-based navigation system. All breaches recorded were minor (<2 mm) and the breach rate (7.14%) was comparable to existing literature. More investigation is needed to evaluate consistency, reproducibility, and performance in surgical context.

Clinical Significance: Intraoperative US-based navigation is feasible and practical for pedicle screw insertion in a porcine model. It might be used as a low-cost and radiation-free alternative to intraoperative CT and fluoroscopy in the future.