Skip to content

Stress Radiography for Pelvic Ring Injuries

Quantitative Stress Radiography With Pelvic Binder for Evaluation of Instability in Lateral Compression Pelvic Ring Injuries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05876871
Enrollment
31
Registered
2023-05-26
Start date
2023-02-01
Completion date
2025-06-30
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Fracture

Keywords

pelvic binder, pelvic ring injury, pelvic instability, stress radiography

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTPelvic Binder Radiography

One series of radiographic exposures

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic fracture displacement at 5 kg of stressAt 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 stressAt diagnostic intervention, immediately following baseline dataLinear 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026