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

NCT02267330 | Completed

• 1 other identifier: 53129
• Study Type: observational
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Fractures; Femur Fractures; Acetabular Fractures; Pelvic Injuries

Keywords

Gonadal Radiation Exposure; Fluoroscopic Imaging; Trauma Surgery; Pelvis fractures; Femur fractures

Outcome Measures

Primary Outcomes (1)

• Gonadal radiation dose

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

  During surgical intervention

Secondary Outcomes (1)

• Fluoroscope-calculated dose.

  During surgical intervention

Study Arms (1)

Standard of care, Exposure recording

Patient will undergo fracture surgery as per standard of care, and will have radiation exposure recording.

Procedure: Exposure Recording

Interventions

Exposure Recording PROCEDURE

Patient undergoing fracture surgery will have radiation exposure recorded

Standard of care, Exposure recording

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients over the age of 18
• Patients with:
• Hip fractures (femoral neck fractures, intertrochanteric fractures)
• Femur fractures (subtrochanteric fractures, femoral shaft fractures)
• Acetabular fractures
• Posterior pelvic ring injuries
• Patients requiring surgical fixation of their injuries per standard of care

You may not qualify if:

• Any patients under the age of 18
• Any patient not fluent in English.
• Hip fracture undergoing prosthetic replacement

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Hip Fractures; Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Thomas Higgins, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: October 17, 2014
• Study Start: February 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 3, 2023

Record last verified: 2023-11