Diagnostic Accuracy and Operational Efficiency of Point-of-Care Ultrasound (POCUS) in Long Bone Fractures: A Brazilian Multicenter Study (POCUS-BONE BR)

July 21, 2026 updated by: Emanuel Ayrton Balanga, University of Sao Paulo

The purpose of this study is to evaluate the diagnostic accuracy and operational efficiency of Point-of-Care Ultrasound (POCUS) for identifying long bone fractures in the emergency department.

Traditionally, suspected long bone fractures are diagnosed using X-rays. While effective, X-rays require transporting patients to a radiology suite, involve exposure to ionizing radiation, and can contribute to longer emergency room wait times. POCUS is a portable, radiation-free imaging tool that physicians perform directly at the patient's bedside. The investigators hypothesize that POCUS can accurately identify or rule out long bone fractures when compared to standard X-rays, and that its use will reduce the time required to make clinical decisions.

This is a multicenter, prospective observational study. Participants arriving at the emergency department with a suspected long bone fracture will undergo a bedside ultrasound examination performed by a trained emergency physician. Following the ultrasound, all participants will receive standard-of-care X-ray imaging.

Researchers will compare the initial POCUS findings to the final X-ray results (the reference standard) to determine the sensitivity and specificity of the ultrasound. Additionally, the study will measure operational timelines-including time to diagnosis, time to treatment decision, and total length of stay in the emergency department-to assess the impact of POCUS on hospital workflow and patient care efficiency.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

## Background and Rationale

Long bone fractures are among the most frequent traumatic injuries managed in emergency departments (EDs) worldwide. The current standard of care for diagnosing these fractures is plain radiography (X-ray). While highly effective and widely available, the standard radiological workflow presents several challenges in crowded ED environments. It requires patient transport to a radiology suite-which can exacerbate pain in trauma patients-involves exposure to ionizing radiation, and often contributes to significant delays in clinical decision-making and overall length of stay (LOS).

Point-of-Care Ultrasound (POCUS) has emerged as a rapid, portable, and radiation-free imaging modality that can be performed directly at the patient's bedside. Previous single-center studies have suggested that POCUS has high sensitivity and specificity for detecting fractures. However, there is a lack of robust, multicenter data evaluating its real-world implementation in diverse Brazilian emergency settings. The POCUS-BONE BR study aims to fill this gap by assessing both the diagnostic accuracy and the operational impact of integrating musculoskeletal POCUS into the standard trauma workflow.

## Study Objectives

**Primary Objective:** To determine the diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of bedside POCUS performed by emergency physicians for the detection of long bone fractures, using standard plain radiography as the reference standard.

**Secondary Objectives:**

  • To evaluate operational efficiency by comparing time-to-diagnosis and time-to-disposition between the POCUS evaluation and standard radiological workflows.
  • To assess patient pain levels during the POCUS examination compared to standard X-ray positioning, using the Visual Analog Scale (VAS).

  • To determine the inter-observer agreement between the emergency physician's POCUS interpretation and the formal radiologist's X-ray report.

    • Study Design and Methodology

POCUS-BONE BR is a prospective, multicenter, observational diagnostic accuracy study. It will be conducted across [Insert Number] participating emergency departments in Brazil.

Eligible patients presenting to the ED with clinical signs of a suspected long bone fracture (involving the femur, tibia, fibula, humerus, radius, or ulna) will be enrolled consecutively. Written informed consent will be obtained from all participants or their legal representatives prior to enrollment.

  • Study Procedures

    1. **Initial Assessment:** Upon ED arrival and triage, patients with suspected long bone fractures will undergo standard clinical evaluation.
    2. **POCUS Examination:** An emergency physician trained in musculoskeletal ultrasound will perform a targeted bedside POCUS examination of the affected limb. The physician will document the presence or absence of a fracture, the fracture type (e.g., cortical disruption), and the time of examination completion.
    3. **Reference Standard Imaging:** Following the POCUS exam, all patients will undergo standard plain radiography of the affected extremity as dictated by standard clinical care.
    4. **Blinding:** The emergency physician performing the POCUS will be blinded to the subsequent X-ray results. The radiologist or attending orthopedist interpreting the definitive X-ray will be blinded to the POCUS findings.
    5. **Clinical Management:** Patient care, analgesia, and orthopedic consultation will proceed according to institutional protocols and will not be delayed by study procedures.
  • Data Collection and Metrics

Trained researchers will collect clinical and operational data using a standardized electronic case report form (eCRF) via [e.g., REDCap]. Key time-stamps recorded will include:

  • Time of ED triage.
  • Time of POCUS completion.
  • Time of X-ray completion.
  • Time to definitive medical decision/orthopedic consultation.

  • Total ED Length of Stay (LOS).

    • Statistical Analysis Plan

Diagnostic accuracy metrics (sensitivity, specificity, positive predictive value, and negative predictive value) will be calculated with 95% confidence intervals using standard 2x2 contingency tables. The agreement between POCUS and X-ray findings will be evaluated using Cohen's kappa coefficient.

Continuous variables (such as time-to-diagnosis and LOS) will be assessed for normality. Parametric data will be analyzed using Student's t-test, and non-parametric data using the Mann-Whitney U test. A p-value of <0.05 will be considered statistically significant. The planned sample size of [Insert Target Sample Size] patients was calculated to achieve a [Insert Power, e.g., 90%] power to detect a sensitivity of at least [Insert Percentage, e.g., 90%] with a predefined margin of error.

Study Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Emanuel A Balanga, Medical Doctor
  • Phone Number: +55 11 965011440
  • Email: eabalanga@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients (18 years of age or older) presenting to the emergency departments of two major Brazilian academic hospitals: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) and Hospital das Clínicas da Faculdade de Medicina de Marília (HCFAMEMA). Eligible participants are those seeking care for acute extremity trauma with clinical suspicion of a long bone fracture, characterized by signs such as localized pain, visible deformity, swelling, or functional limitation. Patients presenting with open fractures, hemodynamic instability requiring immediate resuscitation, known previous fractures in the same anatomical segment, or those requiring immediate surgical intervention are excluded from this study population.

Description

Inclusion Criteria:

  • Patients aged 18 years or older;
  • Presenting with clinical suspicion of a long bone fracture (pain, deformity, swelling, or functional limitation);
  • Provision of informed consent (signed Informed Consent Form - ICF).

Exclusion Criteria:

  • Patients with open fractures;
  • Hemodynamic instability (resuscitation priority);
  • Known previous fractures in the same bone segment;
  • Need for immediate surgical intervention;
  • Refusal to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Arm A
POCUS performed before radiography
Arm B
Radiography performed before POCUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures
Time Frame: From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours.
Sensitivity is the percentage of participants with a long bone fracture confirmed by the reference standard (conventional radiography independently interpreted by a blinded radiologist) who were correctly classified as having a fracture by point-of-care ultrasound (POCUS) performed by a trained emergency physician. Sensitivity is calculated as the number of true positive POCUS examinations divided by the total number of participants with a fracture on the reference standard, multiplied by 100. Reported as a percentage with a 95 percent confidence interval.
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures
Time Frame: From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
Positive predictive value is the percentage of participants with a positive point-of-care ultrasound (POCUS) examination who have a long bone fracture confirmed by the reference standard (conventional radiography independently interpreted by a blinded radiologist). It is calculated as the number of true positive POCUS examinations divided by the total number of positive POCUS examinations, multiplied by 100. Reported as a percentage with a 95 percent confidence interval.
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
Negative Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures
Time Frame: From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
Negative predictive value is the percentage of participants with a negative point-of-care ultrasound (POCUS) examination who have no long bone fracture on the reference standard (conventional radiography independently interpreted by a blinded radiologist). It is calculated as the number of true negative POCUS examinations divided by the total number of negative POCUS examinations, multiplied by 100. Reported as a percentage with a 95 percent confidence interval.
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
Overall Diagnostic Accuracy of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures
Time Frame: From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
Overall diagnostic accuracy is the percentage of participants correctly classified by point-of-care ultrasound (POCUS), calculated as the sum of true positive and true negative POCUS examinations divided by the total number of participants assessed, multiplied by 100. The reference standard is conventional radiography independently interpreted by a blinded radiologist. Reported as a percentage with a 95 percent confidence interval.
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
Interobserver Agreement Between Point-of-Care Ultrasound (POCUS) Operators
Time Frame: From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
Agreement between two independent point-of-care ultrasound (POCUS) operators regarding the presence or absence of a long bone fracture, measured by the Cohen kappa coefficient. Kappa values range from -1 to 1, where 1 indicates perfect agreement, 0 indicates agreement equivalent to chance, and negative values indicate agreement worse than chance. Reported as a kappa coefficient with a 95 percent confidence interval.
From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours
Time From Emergency Department Arrival to Point-of-Care Ultrasound (POCUS) Result
Time Frame: From emergency department arrival to establishment of the fracture diagnosis, assessed up to 24 hours
Time elapsed between emergency department arrival and the moment the point-of-care ultrasound (POCUS) examination result is available to the treating team, reported in minutes.
From emergency department arrival to establishment of the fracture diagnosis, assessed up to 24 hours
Time From Emergency Department Arrival to Radiography Report Availability
Time Frame: From emergency department arrival to establishment of the fracture diagnosis, assessed up to 24 hours
Time elapsed between emergency department arrival and the moment the conventional radiography report is available to the treating team, reported in minutes.
From emergency department arrival to establishment of the fracture diagnosis, assessed up to 24 hours
Emergency Department Length of Stay
Time Frame: From emergency department arrival to emergency department discharge, assessed up to 72 hours
Total time elapsed between emergency department arrival and emergency department exit (hospital admission, transfer to another facility, or discharge home), reported in hours.
From emergency department arrival to emergency department discharge, assessed up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 19, 2026

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

November 20, 2027

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8.574.218
  • Universal Trial Number (UTN) (Registry Identifier: U1111-1343-6273)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared to maintain absolute patient confidentiality, as mandated by the study's Informed Consent Form. All participant data and imaging findings will be de-identified and tracked solely by alphanumeric codes. Furthermore, the dataset will remain restricted to the primary research team and stored securely using the institutional REDCap platform and encrypted local backup drives

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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