Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02267330|
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : May 29, 2015
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.
|Condition or disease||Intervention/treatment|
|Hip Fractures Femur Fractures Acetabular Fractures Pelvic Injuries||Procedure: Exposure Recording|
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 comparatively low doses such as those seen in trauma patients.14,15 Using a more accurate and previously validated model, the stochastic effects of exposure to the reproductive organs can be calculated at a more precise level than provided by previous studies.15,16
The investigators hope this research would allow the orthopaedic community to more accurately express the risks of intraoperative radiation to the patient, while supporting improved training on fluoroscopic technique and promoting the development of less fluoroscopic dependent fixation techniques.
|Study Type :||Observational|
|Actual Enrollment :||135 participants|
|Official Title:||A Descriptive Cohort Analysis of Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery About the Pelvis and Femur|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Standard of care, Exposure recording
Patient will undergo fracture surgery as per standard of care, and will have radiation exposure recording.
Procedure: Exposure Recording
Patient undergoing fracture surgery will have radiation exposure recorded
- 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.
- Fluoroscope-calculated dose. [ Time Frame: During surgical intervention ]The investigators will document fluoroscope-calculated dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267330
|Principal Investigator:||Thomas Higgins, M.D.||University of Utah|