An observational study in Bone Fractures and Long Bone Fracture, sponsored by University of Sao Paulo. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University of Sao Paulo · Observational
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.
## 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 determine the inter-observer agreement between the emergency physician's POCUS interpretation and the formal radiologist's X-ray report.
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
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:
Total ED Length of Stay (LOS).
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 260 is above the median of 130 across 239 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
POCUS performed before radiography
Radiography performed before POCUS
Sensitivity of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures
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.
Time frame: From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours.
Positive Predictive Value of Point-of-Care Ultrasound (POCUS) for the Detection of Long Bone Fractures
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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 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.
Time frame: 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 elapsed between emergency department arrival and the moment the conventional radiography report is available to the treating team, reported in minutes.
Time frame: From emergency department arrival to establishment of the fracture diagnosis, assessed up to 24 hours
Emergency Department Length of Stay
Total time elapsed between emergency department arrival and emergency department exit (hospital admission, transfer to another facility, or discharge home), reported in hours.
Time frame: From emergency department arrival to emergency department discharge, assessed up to 72 hours
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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