Stress Radiography for Pelvic Ring Injuries

NCT05876871 | Completed

• 1 other identifier: HS-22-00217
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Fracture

Keywords

pelvic binder; pelvic ring injury; pelvic instability; stress radiography

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Diagnostic Intervention

OTHER

Diagnostic Test: Pelvic Binder Radiography

Interventions

Pelvic Binder Radiography DIAGNOSTIC_TEST

One series of radiographic exposures

Diagnostic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Joseph T Patterson, MD

  Keck School of Medicine of the University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: May 26, 2023
• Study Start: February 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: June 30, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)