Pelvic Binder Radiography for Pelvic Fracture

Overseen By Pui Yan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Severe psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

31 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Pelvic Binder Radiography for Pelvic Fracture?

Pelvic Binder Radiography can help detect hidden instability in certain types of pelvic fractures, which is important for proper treatment. This method does not require sedation or patient transport, making it a practical option in emergency settings. ^{1 2 3 4 5}

How is Pelvic Binder Radiography different from other treatments for pelvic fractures?

Pelvic Binder Radiography is unique because it uses a pelvic binder to stabilize pelvic injuries during imaging, which can help detect hidden instabilities in certain types of pelvic fractures without needing sedation or additional radiation exposure. This approach is different from standard imaging techniques that might not reveal these hidden issues. ^{1 2 6 7 8}

Research Team

Joseph T Patterson, MD

Principal Investigator

Keck School of Medicine of the University of Southern California

Eligibility Criteria

This trial is for adults over 18 who've been admitted to the Los Angeles County + USC Medical Center within 3 weeks of a specific type of pelvic injury (LC1) from blunt or blast trauma. They must speak English or Spanish and be able to follow up; those with severe psychiatric issues, intellectual challenges without support, living outside the area, prisoners, homeless, or with certain other injuries are excluded.

Inclusion Criteria

My injury was caused by a blunt force or an explosion.

My pelvic injury is being tested under stress conditions.

Presentation within 3 weeks of injury

Exclusion Criteria

I have a severe pelvic injury.

I have a severe pelvic injury that caused internal bleeding and low blood pressure.

I have a severe pelvic injury that needs stabilization.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Intervention

Participants undergo multiple x-rays with varying levels of force applied to the pelvis to assess instability

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic intervention

4 weeks

Treatment Details

Interventions

• Pelvic Binder Radiography

Trial Overview The study tests a new method using stress radiography on patients with LC1 pelvic ring injuries. It aims to measure how much the pelvis moves under pressure to determine stability after an injury. Participants will undergo this novel imaging technique as part of their standard care.

Participant Groups

Group I: Diagnostic Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

References

1. Italy pubmed.ncbi.nlm.nih.gov

An algorithm to avoid missed open-book pelvic fractures. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Pelvic binder radiography detects occult instability in cadaveric simulated lateral compression type I (LC1) pelvic fractures. [2023]

3. England pubmed.ncbi.nlm.nih.gov

In a simulated adult trauma patient, can pelvic binders be applied accurately by paramedics and HEMS paramedics? A pilot observational study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pelvic fractures. [2007]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Identifying risk factors for suboptimal pelvic binder placement in major trauma. [2021]

6. England pubmed.ncbi.nlm.nih.gov

False negative computed tomography scan due to pelvic binder in a patient with pelvic disruption: a case report and review of the literature. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Can MDCT Unmask Instability in Binder-Stabilized Pelvic Ring Disruptions? [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Pelvic Binder Placement on OTA Classification of Pelvic Ring Injuries Using Computed Tomography. Does It Mask the Injury? [2017]