Reducing Radiation an Order of Magnitude During X-Ray Intensive Spinal Procedures Using a Standard Fluoroscope

Presented at SMISS Annual Forum 2014
By Isaac Karikari MD
With D. Anderson MD, Christopher Brown MD,

Disclosures: Isaac Karikari MD None D. Anderson MD , Christopher Brown MD None,

Introduction:
The detrimental effect of ionizing radiation is a well established concern in surgical procedures that utilize standard fluoroscopy. Attempts at reducing the amount of radiation exposure have been based on reducing dose settings and pulse rate on the fluoroscope at the expense of compromising image quality. Herein, we present a new technology, the LessRay®, designed to interface with the standard fluoroscope to enhance image resolution using the lowest dose setting and pulse rates.

Aims/Objectives:
To determine if LessRay® system can generate high resolution images with the lowest automatic radiation dose settings on the standard fluoroscope during a radiation intensive procedure.

Methods:
A prospective, randomized cadaveric study of surgeons performing a routine kyphoplasty. Each surgeon was instructed to perform the procedure in cadaveric specimens imitating their exact routine used in their daily practice. Each surgeon was blinded to either conventional fluoroscope or LessRay® enhanced imaging. Each surgeon repeated the procedure at one spinal level using either the conventional fluoroscopic low-dose settings and at another level using the LessRay® enhanced system. The number of images required prior to cement injection, seconds of fluoroscopy, amount of radiation in mGy were quantified for each surgeon. The Chi-square test was used to determine statistical significance. A p value of <0.05 was considered statistically significant

Results:
Seven spine surgeons performed fourteen (14) kyphoplasties throughout the thoracolumbar spines of 2 human cadavers. In no case did any of the physicians abandon the LessRay® enhanced images. The average duration of fluoroscopy time for the entire procedure was 11.0s and 65.6s in the LessRay® and conventional fluoroscopy groups respectively (p<0.001). Despite statistically similar number of images with both methods prior to cement injection (24 Conventional vs. 21 LessRay®-assisted, p=0.30), the pulsed/low dosed procedures achieved an overall 88.8% radiation reduction over conventional imaging (36.1mGy vs. 4mGy, p< 0.001).

Conclusions:
Our study demonstrates that LessRay® significantly reduces the amount of radiation exposure during a radiation intensive procedure when compared with conventional fluoroscopy. This order of magnitude reduction in radiation can potentially help mitigate the health-hazards associated with ionizing radiation.