Stress Radiography for Pelvic Ring Injuries

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Fracture

Intervention / Treatment
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* Diagnostic Test: Pelvic Binder Radiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic Intervention<br> | Diagnostic Test: Pelvic Binder Radiography<br>* One series of radiographic exposures<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic binder, pelvic ring injury, pelvic instability, stress radiography