Hip FracturesNCT02267330
Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery
An observational study of Hip Fractures and Femur Fractures, run by University of Utah.
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… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hip Fractures, Femur Fractures, Acetabular Fractures
- What is being tested?
- Exposure Recording
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Any patients under the age of 18
- Any patient not fluent in English.
- Hip fracture undergoing prosthetic replacement
About this study
Official title: A Descriptive Cohort Analysis of Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery About the Pelvis and Femur
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.
Read the 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.
- Conditions
- Hip Fractures, Femur Fractures, Acetabular Fractures, Pelvic Injuries
- Being tested
- Exposure Recording
- Keywords
- Gonadal Radiation Exposure, Fluoroscopic Imaging, Trauma Surgery, Pelvis fractures, Femur fractures
- Medical subject headings
- Hip Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure RecordingProcedure or surgery
Patient undergoing fracture surgery will have radiation exposure recorded
| Study group | Role | What they receive |
|---|---|---|
| Standard of care, Exposure recording | Patient will undergo fracture surgery as per standard of care, and will have radiation exposure recording. Receives: Procedure: Exposure Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgical intervention
Secondary outcomes (1)
Fluoroscope-calculated dose.
The investigators will document fluoroscope-calculated dose.
Measured: During surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startFeb 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Higgins, University of Utah
- Investigators
- Thomas Higgins, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267330
- Sponsor's protocol ID
- 53129
- Status last verified
- Nov 2023
- First submitted
- 3 Sep 2014
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Cohort Analysis of Gonadal Radiation Exposure and Risk Secondary to Fluoroscopic Imaging During Trauma Surgery About the Pelvis and Femur
- ClinicalTrials.gov ID
- NCT02267330
- Acronym / sponsor ID
- 53129
- Conditions
- Hip Fractures, Femur Fractures, Acetabular Fractures, Pelvic Injuries
- Keywords
- Gonadal Radiation Exposure, Fluoroscopic Imaging, Trauma Surgery, Pelvis fractures, Femur fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care, Exposure recording | – | Procedure: Exposure RecordingPatient will undergo fracture surgery as per standard of care, and will have radiation exposure recording. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Patients over the age of 18
- Hip fractures (femoral neck fractures, intertrochanteric fractures)
- Femur fractures (subtrochanteric fractures, femoral shaft fractures)
- Acetabular fractures
- Posterior pelvic ring injuries
Key exclusion criteria (3 listed)
- Any patients under the age of 18
- Any patient not fluent in English.
- Hip fracture undergoing prosthetic replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure RecordingPatient undergoing fracture surgery will have radiation exposure recorded | Procedure or surgery | Standard of care, Exposure recording |
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.
1 secondary outcome
Fluoroscope-calculated dose.
Time frame: During surgical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Higgins, M.D. principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Femur Fractures, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gonadal radiation dose (time frame: During surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.