1509. Clinical Efficacy, Accuracy, and Radiation Reduction Using Instrument Tracking and Ultra-Low Radiation Imaging in Minimally Invasive Surgery

Authors: Timothy Y. Wang, MD; Vikram Mehta, MD, MPH; Eric Sankey, MD; Elizabeth Howell; Chester Yarbrough, MD; Muhammad Abd-El-Barr, MD, PhD (Durham, NC)

Introduction:

Image-guided surgery (IGS) reduces blood loss, morbidity, and pain associated with open spine surgery, but it is associated with a substantial increase in patient radiation, operating room time, and a change in surgeon workflow. The principle of ultra-low radiation imaging with image enhancement, coupled with simultaneous instrument tracking (ULRI-IE/IT) is an IGS principle that can be used to reduce procedural radiation exposure, increase surgeon accuracy, and reduce operative time; however, there is currently a lack of clinical data to support or refute this claim.

 

Methods:

A randomized study was performed evaluate radiation exposure, accuracy, and operative time of ULRI-IE/IT compared to conventional fluoroscopy.  Consecutive spine procedures involving multiple levels or left and right-sides were included so that each level could be randomized to either ULRI-IE/IT or standard c-arm fluoroscopy. Number of images taken, radiation, and time to perform each task with or without ULRI-IE/IT were recorded. Given that this was a limited trial, identical cases that did not utilize the technology had similar data recorded in order to supplement the control arm.

Results:

Ten study patients and three control patients were enrolled in this trial. The tasks studied included skin marking, placement of an initial dilator, and instrument localization for hardware placement.  Forty-one total levels had internal controls. Overall, ULRI-IE/IT resulted in radiation reduction of 86% (p<0.001), as well as an 80% overall reduction in localizing images (p<0.001). Overall time reduction was 74% (p<0.001). Cumulatively, ULRI-IE/IT resulted in 123 minutes of saved operating room time.

Conclusions:

ULRI-IE/IT drastically reduced operating room radiation, x-rays required, and procedural time. To date, this is the first clinical study showing that IGS technology using ULRi-IE/IT can make a surgeon safer and more efficient in the OR without significantly impacting preoperative or intraoperative time.