Effect of Instrument Navigation on C-arm Radiation and Time during Spinal Procedures: A Clinical Evaluation

Introduction As minimally invasive spine surgery gains popularity, a focused effort must be made to reduce intraoperative radiation exposure to levels as low as reasonably achievable. Here, we demonstrate the clinical efficacy of a novel technology to aid in instrument navigation that aims to reduce intraoperative radiation exposure, number of fluoroscopic images, and time required to perform the most radiation intensive portions of a multitude of spinal procedures.

Methods An internally randomized controlled study was performed over a 1-month period in order to clinically evaluate the effect of the C-arm assisted instrument tracking system, TrackX, on surgeon workflow, time, and radiation emitted. Three surgeons performed multiple spinal procedures on a total of 10 study patients and an additional 3 control patients. The surgeries encompassed minimally invasive spinal techniques and spanned extreme lateral interbody fusion, oblique lumbar interbody fusion, transforaminal lumbar interbody fusion along with percutaneous iliac screw placement, hardware removal, and kyphoplasty. The tasks studied included skin marking, first dilator insertion, localization for hardware placement and hardware removal.

Results Overall radiation reduction was 83% (P < .0001). Overall reduction in x-rays taken was 78% (P < .0001). Overall time reduction was 81% (P = .0003). Statistical significance held for each surgeon studied and for nearly every procedure type. In these 10 study procedures, over 2 hours of overall operating room time was saved, all while requiring negligible set up time and no system calibration or supplementary x-rays to be taken. There were no adverse outcomes for any study patient, and there was no case where TrackX was not able to successfully complete a given portion of a procedure.

Conclusions TrackX instrument navigation is a clinically efficacious and accurate instrument tracking modality. This is the first instrument navigational technology that reduces radiation exposure and images required to complete a procedure while decreasing operative time. TrackX thus allows increased surgical efficiency while increasing operative efficiency and improving intraoperative safety.

Level of Evidence 2.