Fluoroscopy for Spine Surgery Clinical Trial
Official title:
A Prospective, Randomized Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator Epidural Array
The purpose of this study is to gather information comparing LessRay Enhanced fluoroscopy with the current standard of fluoroscopy. This research is being conducted to demonstrate the utility and effectiveness of LessRay Enhanced fluoroscopy during surgical placement of a spinal cord stimulator epidural array.
The purpose of this prospective, randomized single center study is to assess the ability of
LessRay to decrease overall radiation exposure during surgical placement of a spinal
stimulator. A secondary objective is to analyze the efficacy of utilizing enhanced low
radiation imaging in a fluoroscopically intensive pain procedure.
The population group will be 65 patients from Duke University Medical Center and Duke Raleigh
Hospital who meet the medical criteria for the surgical placement of a spinal cord stimulator
epidural array. They will be divided equally into 2 arms: Research and Control and randomized
by a non-surgeon on the study team. That information will be recorded and placed in a sealed
envelope. On the day of surgery the envelope will be delivered to the OR and opened following
"time-out". At the time the envelope is opened in the OR the patient is acknowledged to be
evaluable for failure or success of LessRay during the surgical procedure if they are in the
research arm. The control arm cohort will proceed with the surgery as typical without
LessRay.
The data from the two groups (Research vs. Control) will be analyzed using a two tailed
t-test with p<.05. The risks associated specifically with the implementation of this study
are with respect to loss of confidentiality. Every effort will be made to keep the
information confidential
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