Stress Radiography for Pelvic Ring Injuries

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Fracture
• Intervention / Treatment: Diagnostic test: Pelvic Binder Radiography

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Diagnostic Intervention	Diagnostic test: Pelvic Binder Radiography; One series of radiographic exposures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At diagnostic intervention, immediately following baseline data

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Joseph T Patterson, MD, Keck School of Medicine of the University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: pelvic ring injury; stress radiography; pelvic binder; pelvic instability
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: HS-22-00217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No