Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02267330 |
Other study ID # |
53129 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 2012 |
Est. completion date |
May 2015 |
Study information
Verified date |
November 2023 |
Source |
University of Utah |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
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.