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Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopedic Procedures
This study is currently recruiting participants.
Verified on June 2011 by Loma Linda University

FirstReceived on August 20, 2009. Last Updated on June 20, 2011 History of Changes
Sponsor: | Loma Linda University |
Information provided by: | Loma Linda University |
ClinicalTrials.gov Identifier: |NCT00972647 |
Purpose
Introduction: The orthopaedic surgeon is frequently exposed to ionizing radiation, especially during intraoperative fluoroscopy. It is expected that using a laser guidedfluoroscopy technique, which should improve accuracy of radiography, should also reduce the amount of time of exposure to radiation. Finally, the literature appears controversial in this matter with noclear conclusions that could be drawn from such.
Hypothesis: The test hypothesis is that the use of the laser-aiming device for fluoroscopy in several orthopaedic procedures will reduce the exposure ofthe patient and the surgeon to the damaging effects of radiation. The null hypothesis then states that there will be no difference in exposure to radiation between the group using the laser device andthe group not using the apparatus.
Methods: A prospective randomized controlled trial will be performed in which patients undergoing fluoroscopy will be randomly allocated to two groups. One groupwill undergo imaging with use of the device throughout the procedure and the other group will undergo radiation without the laser guided device. Number and time of exposure will be recorded for eachprocedure. It is of the utmost importance that the complexity of the procedures remains relatively similar. It is believed that a good measure of complexity is the surgical time. Therefore, anyprocedures that are statistically similar from a set mean (p > 0.05) would be included into the study. It is also important that one or two surgeons with similar expertise and years of experience perform...