Internally Randomized Control Trial of Radiation Exposure Using Ultra-low Radiation Imaging Versus Traditional C-arm Fluoroscopy for Patients Undergoing Single-level Minimally Invasive Transforaminal Lumbar Interbody Fusion.

STUDY DESIGN Randomized controlled trial. OBJECTIVE To compare radiation exposure between ultra-low radiation imaging (ULRI) with image enhancement and standard-dose fluoroscopy for patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). SUMMARY OF BACKGROUND DATA Although the benefits of MIS are lauded by many, there is a significant amount of radiation exposure to surgeon and operating room personnel. Our goal with this work was to see if by using ultra-low dose radiation settings coupled with image enhancement, this exposure could be minimized. METHODS An institutional review board approved, prospective, internally randomized controlled trial was performed comparing ultra-low dose settings coupled with image enhancement software to conventional fluoroscopic imaging. In this study, each patient served as their own control, randomly assigning one side of MIS-TLIF for cannulation and K-wire placement using each imaging modality. Further, the case was also randomly divided into screw placement and cage placement/final images to allow further comparisons amongst patients. Radiation production from the C-arm fluoroscope and radiation exposure to all operating room personnel were recorded. RESULTS Twenty-four patients were randomly assigned to undergo a single level MIS-TLIF. In no case was low radiation imaging abandoned, and no patient had a neurologic decline or required hardware repositioning. Everyone in the operating room-the physician, scrub nurse, circulator, and anesthesiologist-all benefited with 61.6% to 83.5% reduction in radiation exposure during cannulation and K-wire placement to screw insertion aided by ULRI. In every case but the anesthesiologist dose, this was statistically significant (P  CONCLUSION ULRI, when aided by image enhancement software, affords the ability for all parties in the operating room to substantially decrease their radiation exposure compared with standard-dose C-arm fluoroscopy without adding additional time or an increased complication rate. LEVEL OF EVIDENCE 2.