Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery
Condition: Hip Fractures; Femur Fractures; Acetabular Fractures; Pelvic Injuries
MeSH terms: Fractures, Bone; Hip Fractures; Femoral Fractures
Study type: Observational

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 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.
    

Intervention name(s): Exposure Recording
Intervention type(s): Procedure
Intervention description(s): Patient undergoing fracture surgery will have radiation exposure recorded
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be identified for inclusion in the study through routine trauma workup
        performed at the University of Utah. Patients will be managed through standard of care
        treatment as dictated by their injuries. If standard of care treatment dictates that a
        patient requires operative intervention for their injuries and injury pattern is found to
        meet inclusion criteria, an orthopaedics attending or resident physician will determine the
        patient's ability to enter the study.
      
Keywords: Gonadal Radiation Exposure; Fluoroscopic Imaging; Trauma Surgery; Pelvis fractures; Femur fractures