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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method to better understand pelvic injuries, focusing on cases where bones are partially broken but not fully unstable. It employs pelvic binder radiography, an imaging technique, to measure bone movement under pressure. The trial seeks individuals who have experienced a specific type of pelvic injury from a car accident or similar blunt force within the last three weeks. Participants should have no other severe pelvic injuries and must communicate in English or Spanish. As an unphased study, this trial provides participants an opportunity to contribute to innovative research that could enhance future treatment methods for pelvic injuries.

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 prior data suggests that this method is safe for assessing pelvic ring injuries?

Research has shown that Pelvic Binder Radiography (PBR) is safe and practical for patients with pelvic fractures. In studies, at least 85% of patients found PBR comfortable. Importantly, no major side effects were reported, indicating that most people did not experience serious issues during the procedure. This test is conducted at the treatment location, such as an emergency room, which can reassure those considering participation in a clinical trial involving PBR. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pelvic binder radiography because it offers a new approach to diagnosing pelvic fractures, which are usually identified through traditional X-rays or CT scans. Unlike these standard methods, pelvic binder radiography could provide a quicker and more accessible way to assess injuries, especially in emergency situations or resource-limited settings. This technique might improve initial assessment accuracy without needing complex equipment, helping medical teams make faster decisions about treatment.

What evidence suggests that Pelvic Binder Radiography is effective for pelvic fracture?

Research shows that using X-rays with a pelvic binder safely and practically checks for instability in pelvic fractures. One study found that this method effectively identifies hidden instability in certain types of pelvic fractures. Although some studies suggest pelvic binders might not significantly affect outcomes for unstable fractures, using this X-ray method at the point of care helps doctors better understand the fracture's stability. This trial will evaluate the effectiveness of pelvic binder radiography as a diagnostic intervention, potentially leading to more informed treatment decisions. Overall, this approach promises accurate diagnosis of certain pelvic injuries. ^{1 2 3 6 7}

Who Is on the Research Team?

Joseph T Patterson, MD

Principal Investigator

Keck School of Medicine of the University of Southern California

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12366959/

The pelvic2bind cross-sectional survey study Furthermore, 95% estimated that ≤ 50% of patients with pelvic fractures actually bled due to the fracture, and 88.5% reported that fewer than ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1479666X25001301

Are pelvic binders an effective measure to lower mortality ... The aim of this review is to systematically analyse the literature to assess the effectiveness of pelvic binders in reducing blood product ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39431810/

Pelvic Binder Radiography Is Safe and Feasible for ... Conclusions: PBR is feasible and safe as a point-of-care test for LC1 pelvis fracture instability. Level of evidence: Level II Diagnostic.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138323007714

Pelvic binder radiography detects occult instability in ... Pelvic binder stress radiography (PBR) and bladder manometry (PBM) are novel point-of-care tests for occult instability in LC1 pelvis fractures.

5. injuryjournal.com injuryjournal.com/article/S0020-1383(24)00079-2/fulltext

Does a prehospital applied pelvic binder improve patient ... Our study found that prehospital pelvic binders did not significantly impact patient outcomes for unstable pelvic fractures, with injury ...

6. europepmc.org europepmc.org/article/med/39431810

Pelvic Binder Radiography Is Safe and Feasible for ... The primary outcome was fracture displacement on PBR. Secondary outcomes included feasibility (≥85% patient tolerance) and safety (no major adverse events).

7. injuryjournal.com injuryjournal.com/article/S0020-1383(23)00771-4/abstract

Pelvic binder radiography detects occult instability in ... A clinical trial to validate the safety and efficacy of PBR for identifying occult instability in LC1 pelvis fracture is warranted. Abstract.