Bone FracturesPOCUS-BONE BRNCT07728227
Diagnostic Accuracy and Operational Efficiency of Point-of-Care Ultrasound (POCUS) in Long Bone Fractures: A Brazilian Multicenter Study
An observational study of Bone Fractures and Long Bone Fracture, run by University of Sao Paulo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Fractures, Long Bone Fracture
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 20 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Patients with open fractures;
- Hemodynamic instability (resuscitation priority);
- Known previous fractures in the same bone segment;
- Need for immediate surgical intervention;
- Refusal to participate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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
- Initial Assessment: Upon ED arrival and triage, patients with suspected long bone fractures will undergo standard clinical evaluation.
- 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.
- Reference Standard Imaging: Following the POCUS exam, all patients will undergo standard plain radiography of the affected extremity as dictated by standard clinical care.
- 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.
- 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.
- Conditions
- Bone Fractures, Long Bone Fracture
- Keywords
- POCUS, Ultrassound, Fractures, Bones, POCUS BONES BR
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | POCUS performed before radiography | |
| Arm B | Radiography performed before POCUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From emergency department arrival to completion of the reference standard radiography, assessed up to 24 hours.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From emergency department arrival to emergency department discharge, assessed up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start19 Oct 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuel Ayrton Balanga, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728227
- Sponsor's protocol ID
- 8.574.218
- Other IDs
- Universal Trial Number (UTN)
- Acronym
- POCUS-BONE BR
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Ribeiro MCF, Ribeiro MEF, Da Silva Dos Santos G, De Santos Lima AK, Leonel BMC, De Castro Trindade MMM, et al. Perfil epidemiológico das internações por fratura de fêmur no Brasil entre 2019 a 2023. Brazilian Journal of Implantology and Health Sciences [Internet]. 2024 Jun 17;6(6):1154¿64. Available from: https://bjihs.emnuvens.com.br/bjihs/article/view/2331
GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.
PubMed 34723233Delniotis I, Bontinis V, Ktenidis K, Drakonaki EE, Galanis N. Diagnostic accuracy of ultrasound versus X-ray for distal forearm fractures in children and adolescents: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2024 Dec;50(6):2649-2662. doi: 10.1007/s00068-024-02451-9. Epub 2024 Feb 1.
PubMed 38300283Matschiner E, Serban O, Fodor D, Blaivas M, Horn R, Koch J, Jakobi ML, Grevelding L, Osterwalder J, Srivastava D, Dietrich CF. Ultrasound in bone fracture diagnosis - a comparative meta-analysis and systematic review. Med Ultrason. 2025 Mar 2;27(1):52-62. doi: 10.11152/mu-4407. Epub 2024 Jun 28.
PubMed 39078997Douma-den Hamer D, Blanker MH, Edens MA, Buijteweg LN, Boomsma MF, van Helden SH, Mauritz GJ. Ultrasound for Distal Forearm Fracture: A Systematic Review and Diagnostic Meta-Analysis. PLoS One. 2016 May 19;11(5):e0155659. doi: 10.1371/journal.pone.0155659. eCollection 2016.
PubMed 27196439Osterwalder J, Hoffmann B, Blaivas M, Horn R, Matchiner E, Dietrich CF. A Plea for a Paradigm Shift from X-Ray to Ultrasound in Adults: An Update for Emergency Physicians, General Practitioners, Orthopedists and Sports Medicine Physicians. Diagnostics (Basel). 2025 Jul 21;15(14):1827. doi: 10.3390/diagnostics15141827.
PubMed 40722577Smith KM, Zimmerman E, Trotter Z, Wai S. Diagnostic Accuracy of Point-of-Care Ultrasound for Acute Pediatric Ankle Injuries. Pediatr Emerg Care. 2025 Oct 1;41(10):e140-e145. doi: 10.1097/PEC.0000000000003439. Epub 2025 Jul 9.
PubMed 40629668Delniotis I, Bontinis V, Delniotis A, Bontinis A, Drakonaki EE, Ktenidis K, Galanis N. Point-of-Care Ultrasound Versus X-ray for Pediatric Upper Extremity Injuries: A Safe and Radiation-Free Alternative? Pediatr Emerg Care. 2025 Oct 1;41(10):e156-e162. doi: 10.1097/PEC.0000000000003446. Epub 2025 Jul 11.
PubMed 40643022Endara-Mina J, Kumar H, Ghosh B, Mehta A, Chandra Dey R, Singh P, Rai N, Mandadi M, Opara O, Quinonez J. Comparative use of ultrasound and radiography for the detection of fractures: a systematic review and narrative synthesis. Ann Med Surg (Lond). 2023 Sep 5;85(10):5085-5095. doi: 10.1097/MS9.0000000000001229. eCollection 2023 Oct.
PubMed 37811018
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy and Operational Efficiency of Point-of-Care Ultrasound (POCUS) in Long Bone Fractures: A Brazilian Multicenter Study
- ClinicalTrials.gov ID
- NCT07728227
- Acronym / sponsor ID
- POCUS-BONE BR / 8.574.218
- Conditions
- Bone Fractures, Long Bone Fracture
- Keywords
- POCUS, Ultrassound, Fractures, Bones, POCUS BONES BR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Initial Assessment: Upon ED arrival and triage, patients with suspected long bone fractures will undergo standard clinical evaluation.
- 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.
- Reference Standard Imaging: Following the POCUS exam, all patients will undergo standard plain radiography of the affected extremity as dictated by standard clinical care.
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | –POCUS performed before radiography |
| Arm B | – | –Radiography performed before POCUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- Patients with open fractures;
- Hemodynamic instability (resuscitation priority);
- Known previous fractures in the same bone segment;
- Need for immediate surgical intervention;
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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 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
Emergency Department Length of Stay
Time frame: From emergency department arrival to emergency department discharge, assessed up to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- BackgroundRibeiro MCF, Ribeiro MEF, Da Silva Dos Santos G, De Santos Lima AK, Leonel BMC, De Castro Trindade MMM, et al. Perfil epidemiológico das internações por fratura de fêmur no Brasil entre 2019 a 2023. Brazilian Journal of Implantology and Health Sciences [Internet]. 2024 Jun 17;6(6):1154¿64. Available from: https://bjihs.emnuvens.com.br/bjihs/article/view/2331
- Background: PubMed 34723233GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.
- Background: PubMed 38300283Delniotis I, Bontinis V, Ktenidis K, Drakonaki EE, Galanis N. Diagnostic accuracy of ultrasound versus X-ray for distal forearm fractures in children and adolescents: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2024 Dec;50(6):2649-2662. doi: 10.1007/s00068-024-02451-9. Epub 2024 Feb 1.
- Background: PubMed 39078997Matschiner E, Serban O, Fodor D, Blaivas M, Horn R, Koch J, Jakobi ML, Grevelding L, Osterwalder J, Srivastava D, Dietrich CF. Ultrasound in bone fracture diagnosis - a comparative meta-analysis and systematic review. Med Ultrason. 2025 Mar 2;27(1):52-62. doi: 10.11152/mu-4407. Epub 2024 Jun 28.
- Background: PubMed 27196439Douma-den Hamer D, Blanker MH, Edens MA, Buijteweg LN, Boomsma MF, van Helden SH, Mauritz GJ. Ultrasound for Distal Forearm Fracture: A Systematic Review and Diagnostic Meta-Analysis. PLoS One. 2016 May 19;11(5):e0155659. doi: 10.1371/journal.pone.0155659. eCollection 2016.
- Background: PubMed 40722577Osterwalder J, Hoffmann B, Blaivas M, Horn R, Matchiner E, Dietrich CF. A Plea for a Paradigm Shift from X-Ray to Ultrasound in Adults: An Update for Emergency Physicians, General Practitioners, Orthopedists and Sports Medicine Physicians. Diagnostics (Basel). 2025 Jul 21;15(14):1827. doi: 10.3390/diagnostics15141827.
- Background: PubMed 40629668Smith KM, Zimmerman E, Trotter Z, Wai S. Diagnostic Accuracy of Point-of-Care Ultrasound for Acute Pediatric Ankle Injuries. Pediatr Emerg Care. 2025 Oct 1;41(10):e140-e145. doi: 10.1097/PEC.0000000000003439. Epub 2025 Jul 9.
- Background: PubMed 40643022Delniotis I, Bontinis V, Delniotis A, Bontinis A, Drakonaki EE, Ktenidis K, Galanis N. Point-of-Care Ultrasound Versus X-ray for Pediatric Upper Extremity Injuries: A Safe and Radiation-Free Alternative? Pediatr Emerg Care. 2025 Oct 1;41(10):e156-e162. doi: 10.1097/PEC.0000000000003446. Epub 2025 Jul 11.
- Background: PubMed 37811018Endara-Mina J, Kumar H, Ghosh B, Mehta A, Chandra Dey R, Singh P, Rai N, Mandadi M, Opara O, Quinonez J. Comparative use of ultrasound and radiography for the detection of fractures: a systematic review and narrative synthesis. Ann Med Surg (Lond). 2023 Sep 5;85(10):5085-5095. doi: 10.1097/MS9.0000000000001229. eCollection 2023 Oct.
- Individual participant dataSharing planned: 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
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RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Fractures and Long Bone Fracture, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuel A Balanga, Medical Doctor (+55 11 965011440, eabalanga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07728227, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.