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 < 0.05). This benefit required no additional time (P = 0.78 for K-wire placement).

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