Clinical Trial: Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Descriptive Cohort Analysis of Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery About the Pelvis and Femur

Brief Summary:

The aim of this cohort study is to precisely measure patients' exposure to gonadal radiation during orthopaedic trauma surgery involving the acetabulum, pelvis, hip, and femur, and to apply these findings to a previously described and validated formula to determine the increased risk of future adverse health effects to the reproductive organs.

The investigators null hypothesis is standard of care use of x-ray fluoroscopy during treatment of pelvis, hip, and femur fractures will not expose patients to a significant gonadal radiation load. Analysis of patients' intraoperative radiation doses by means of a previously validated formula will not display a significantly increased risk of adverse health events in the reproductive organs.


Detailed Summary:

In the United States, physicians treat more than one and a half million fractures of the pelvis, hip, and femur each year.1-3 Exposure of patients to ionizing radiation during both diagnosis and treatment of these injuries is an unfortunate reality in the standard of care.

Regulations put forth by the US National Radiation Committee (USNRC) include limiting maximum radiation exposure, above background levels, to individual members of the public to less than 1 millisievert (mSv) per year.4 While no current recommendations exist regarding medical exposure in patients, physicians are expected to display judicious practice of both diagnostic and therapeutic procedures during which patients are exposed to ionizing radiation.4 Nevertheless, patients whom undergo trauma activation are exposed to radiation levels that are significant and possibly excessive at 25 to 32 mSv during admission.5,6 The probability that radiation exposure may be reduced is supported by previous studies, which have established that only 60% of surgical trainees take into account the risks of radiation to a patient and that training on intraoperative fluoroscopy technique can decrease patient exposure by more than 50%, while maintaining an equivalent result.7,8

Few previous studies have addressed patient exposure to radiation during operative treatment of orthopaedic injuries.5,9,10 Previous research documenting radiation dose during surgeries of the pelvis and femur have used fluoroscope-calculated dose area product (DAP), which is less accurate than the direct dosimetry proposed in our study.11-13 Furthermore, prior studies have inappropriately determined stochastic risk through the linear no-threshold (LNT) model, which according to the USNRC, provides limited statistical power for epidemiologically based conclusions and overestimates risk at comparativ
Sponsor: University of Utah

Current Primary Outcome: Gonadal radiation dose [ Time Frame: During surgical intervention ]

The primary outcome variable will be patient gonadal radiation dose documented through dosimeter application and analysis during standard of care operative intervention.


Original Primary Outcome: Same as current

Current Secondary Outcome: Fluoroscope-calculated dose. [ Time Frame: During surgical intervention ]

The investigators will document fluoroscope-calculated dose.


Original Secondary Outcome: Same as current

Information By: University of Utah

Dates:
Date Received: September 3, 2014
Date Started: February 2012
Date Completion:
Last Updated: May 28, 2015
Last Verified: May 2015