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OpenTrials
Completed

NCT Number: NCT05876871

Stress Radiography for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic Binder Radiography

Diagnostic Test

One series of radiographic exposures

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
May 26, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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