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Stress Radiography for Pelvic Ring Injuries

Primary Purpose

Pelvic Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic Binder Radiography
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pelvic Fracture focused on measuring pelvic binder, pelvic ring injury, pelvic instability, stress radiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keck Medical Center of USCRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diagnostic Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
May 22, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05876871
Brief Title
Stress Radiography for Pelvic Ring Injuries
Official Title
Quantitative Stress Radiography With Pelvic Binder for Evaluation of Instability in Lateral Compression Pelvic Ring Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Fracture
Keywords
pelvic binder, pelvic ring injury, pelvic instability, stress radiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic Intervention
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Pelvic Binder Radiography
Intervention Description
One series of radiographic exposures
Primary Outcome Measure Information:
Title
Pelvic fracture displacement at 5 kg of stress
Description
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.
Time Frame
At diagnostic intervention, immediately following baseline data collection.
Title
Pelvic fracture displacement at 10 kg of stress
Description
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.
Time Frame
At diagnostic intervention, immediately following baseline data

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pui Yan
Phone
(323) 442-6984
Email
PuiYan@med.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph T Patterson, MD
Organizational Affiliation
Keck School of Medicine of the University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pui Yan, MS
Phone
323-442-6984

12. IPD Sharing Statement

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Stress Radiography for Pelvic Ring Injuries

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