Stress Radiography for Pelvic Ring Injuries

Pelvic Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05876871
• Other study ID #: HS-22-00217
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures
• Pelvic Fracture

Intervention

Diagnostic Test:
• Pelvic Binder Radiography
One series of radiographic exposures

Locations

Country	Name	City	State
United States	Keck Medical Center of USC	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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