Pelvic FractureNCT05876871
Stress Radiography for Pelvic Ring Injuries
A study testing Pelvic Binder Radiography in people with Pelvic Fracture, run by University of Southern California at 1 site in United States.
Trial summary
The primary aim of this investigation is to prospectively and clinically validate a novel, reproducible method of quantitative application of compressive stress to a LC1 pelvic ring injury of indeterminate stability for the purpose of assessing quantitative pelvic ring displacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Fracture
- What is being tested?
- Pelvic Binder Radiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 30 Jun 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Acute emergency department admission or transfer to Los Angeles County + USC Medical Center
- Presentation within 3 weeks of injury
- Blunt or blast mechanism of traumatic injury
- Lateral compression pelvic ring injury with unilateral incomplete disruption of the posterior arch (OTA/AO 61B1.1/2.2; Young Burgess LC1) on radiographs and/or computed tomography scan of the pelvis obtained per routine care
- LC1 pelvic ring injuries occurring in isolation are virtually never associated with hemodynamic instability or critical patient condition
- Stress examination of LC1 pelvic ring injury is standard of care
- Patient must speak either English or Spanish
Who cannot join
- Volume expanding pelvic ring injury (Young-Burgess APC-2 and 3, LC-3, vertical shear, and combined mechanism of injury (CMI) (Tile B and C patterns; OTA codes 61-B and 61-C).
- Volume expanding pelvic ring injury injuries represent the types of pelvic ring disruption responsible for pelvic hemorrhage and hypotension and are correlate with patient hemodynamic instability as well as critical injuries
- Volume expanding pelvic ring injury injuries warrant stabilization with circumferential pelvic compression.
- Patients with volume expanding pelvic ring injury are not clinically appropriate for this study.
- Hemodynamic instability or hypotension angioembolization (AE), preperitoneal pelvic packing (PPP), or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) to obtain or maintain hemodynamic stability
- Bladder, vaginal, rectal, colonic, or other abdominal or pelvic organ injury precluding safe application of circumferential pelvic compression device
Show all 12Show fewer
- Patient likely to have severe problems with maintaining follow- up due to at least one of the following:
- Patient has been diagnosed with a severe psychiatric condition
- Patient is intellectually challenged without adequate family support
- Patient lives outside the hospital's catchment area
- Follow-up is planned at another medical center
- Patients who are prisoners or homeless
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck Medical Center of USC
Los Angeles, California, 90033
About this study
Official title: Quantitative Stress Radiography With Pelvic Binder for Evaluation of Instability in Lateral Compression Pelvic Ring Injuries
The primary aim of this investigation is to prospectively and clinically validate a novel, reproducible method of quantitative application of compressive stress to a LC1 pelvic ring injury of indeterminate stability for the purpose of assessing quantitative pelvic ring displacement.
Read the detailed description
patients will receive a diagnostic intervention with multiple x-rays. These x-rays will be taken as different levels of force are applied to the pelvis. This will be used to determine instability as an indication for surgical intervention to stabilize the pelvic ring.
- Conditions
- Pelvic Fracture
- Being tested
- Pelvic Binder Radiography
- Keywords
- pelvic binder, pelvic ring injury, pelvic instability, stress radiography
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Binder RadiographyDiagnostic test
One series of radiographic exposures
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Intervention | Other | Not described Receives: Diagnostic Test: Pelvic Binder Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic fracture displacement at 5 kg of stress
Linear displacement of the pelvis fracture defined as the difference in distance measured at the acetabular teardrops on a pelvis inlet radiograph with no applied stress and a pelvis inlet radiograph with 5 kg of stress applied with the pelvic binder.
Measured: At diagnostic intervention, immediately following baseline data collection.
Pelvic fracture displacement at 10 kg of stress
Linear displacement of the pelvis fracture defined as the difference in distance measured at the acetabular teardrops on a pelvis inlet radiograph with no applied stress and a pelvis inlet radiograph with 10 kg of stress applied with the pelvic binder.
Measured: At diagnostic intervention, immediately following baseline data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Feb 2023
- Primary completion20 Dec 2023
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Patterson, University of Southern California
- Investigators
- Joseph T Patterson, MD, Principal investigator, Keck School of Medicine of the University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876871
- Sponsor's protocol ID
- HS-22-00217
- Status last verified
- Jul 2025
- First submitted
- 28 Sep 2022
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Stress Radiography With Pelvic Binder for Evaluation of Instability in Lateral Compression Pelvic Ring Injuries
- ClinicalTrials.gov ID
- NCT05876871
- Acronym / sponsor ID
- HS-22-00217
- Conditions
- Pelvic Fracture
- Keywords
- pelvic binder, pelvic ring injury, pelvic instability, stress radiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 26 May 2023 (actual)
- 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 primary aim of this investigation is to prospectively and clinically validate a novel, reproducible method of quantitative application of compressive stress to a LC1 pelvic ring injury of indeterminate stability for the purpose of assessing quantitative pelvic ring displacement.
Detailed description
patients will receive a diagnostic intervention with multiple x-rays. These x-rays will be taken as different levels of force are applied to the pelvis. This will be used to determine instability as an indication for surgical intervention to stabilize the pelvic ring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Intervention | Other | Diagnostic Test: Pelvic Binder Radiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Acute emergency department admission or transfer to Los Angeles County + USC Medical Center
- Presentation within 3 weeks of injury
- Blunt or blast mechanism of traumatic injury
- Lateral compression pelvic ring injury with unilateral incomplete disruption of the posterior arch (OTA/AO 61B1.1/2.2; Young Burgess LC1) on radiographs and/or computed tomography scan of the pelvis obtained per routine care
Key exclusion criteria (12 listed)
- Volume expanding pelvic ring injury (Young-Burgess APC-2 and 3, LC-3, vertical shear, and combined mechanism of injury (CMI) (Tile B and C patterns; OTA codes 61-B and 61-C).
- Volume expanding pelvic ring injury injuries represent the types of pelvic ring disruption responsible for pelvic hemorrhage and hypotension and are correlate with patient hemodynamic instability as well as critical injuries
- Volume expanding pelvic ring injury injuries warrant stabilization with circumferential pelvic compression.
- Patients with volume expanding pelvic ring injury are not clinically appropriate for this study.
- Hemodynamic instability or hypotension angioembolization (AE), preperitoneal pelvic packing (PPP), or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) to obtain or maintain hemodynamic stability
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 |
|---|---|---|
| Pelvic Binder RadiographyOne series of radiographic exposures | Diagnostic test | Diagnostic Intervention |
Primary outcome
Pelvic fracture displacement at 5 kg of stress
Time frame: At diagnostic intervention, immediately following baseline data collection.
Linear displacement of the pelvis fracture defined as the difference in distance measured at the acetabular teardrops on a pelvis inlet radiograph with no applied stress and a pelvis inlet radiograph with 5 kg of stress applied with the pelvic binder.
Pelvic fracture displacement at 10 kg of stress
Time frame: At diagnostic intervention, immediately following baseline data
Linear displacement of the pelvis fracture defined as the difference in distance measured at the acetabular teardrops on a pelvis inlet radiograph with no applied stress and a pelvis inlet radiograph with 10 kg of stress applied with the pelvic binder.
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 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Joseph T Patterson, MD principal investigator
Keck School of Medicine of the University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Binder Radiography in people with Pelvic Fracture, run by University of Southern California at 1 site in United States.
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 8 inclusion and 12 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 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pelvic fracture displacement at 5 kg of stress (time frame: At diagnostic intervention, immediately following baseline data collection.). The study lists 2 primary outcomes in all. 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 8 Jul 2025.