Pediatric Ankle FractureNCT07872124
Point-of-Care Ultrasonography for Pediatric Ankle Fracture Detection
An observational study of Pediatric Ankle Fracture, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluated the diagnostic accuracy of point-of-care ultrasonography (POCUS) for detecting ankle fractures in children presenting to the emergency department with acute isolated ankle trauma. Children aged 5-17 years who met at least one Ottawa Ankle Rule criterion were included. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Pediatric Ankle Fracture
- What is being tested?
- Point-of-Care Ultrasonography (POCUS)
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Jul 2025
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consisted of pediatric patients presenting with acute ankle trauma to the emergency department of a tertiary academic referral hospital. Consecutive patients were screened for study eligibility during the study period. The study focused on children for whom ankle radiography was clinically indicated according to the Ottawa Ankle Rules.
Who may be able to join
- Age 5-17 years
- Presentation to the emergency department with acute isolated ankle trauma
- Fulfillment of at least one Ottawa Ankle Rule criterion
- Written informed consent provided by the participant's legal guardian
Who cannot join
- Polytrauma
- Penetrating ankle injury
- Clinically obvious deformity requiring immediate reduction
- Previous surgery to the affected ankle
- Inability to undergo point-of-care ultrasonography (POCUS)
- Refusal of informed consent
- Repeated eligible presentation after a participant had already been enrolled in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Istanbul Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Küçükçekmece, 34303
About this study
Official title: Point-of-Care Ultrasonography for Pediatric Ankle Fracture Detection: High Sensitivity But Reduced Specificity Around Open Physes
This prospective observational study evaluated the diagnostic accuracy of point-of-care ultrasonography (POCUS) for detecting ankle fractures in children presenting to the emergency department with acute isolated ankle trauma. Children aged 5-17 years who met at least one Ottawa Ankle Rule criterion were included.
The primary objective was to determine how accurately bedside POCUS identifies pediatric ankle fractures compared with a predefined reference standard. The study also evaluated whether the presence of open growth plates influenced ultrasound interpretation.
Read the detailed description
This was a prospective, single-center observational diagnostic accuracy study conducted in the emergency department of a tertiary academic referral hospital. Consecutive children presenting with acute isolated ankle trauma were screened for eligibility. Participants were eligible if they were 5-17 years of age and fulfilled at least one Ottawa Ankle Rule criterion.
All POCUS examinations were performed before radiographic imaging using a high-frequency linear transducer. The distal tibia, distal fibula, talus, calcaneus, and navicular were systematically evaluated in longitudinal and transverse planes, with particular attention to the region of maximal tenderness. A POCUS examination was considered positive when cortical discontinuity, step-off, or focal cortical irregularity compatible with fracture was identified and negative when these findings were absent.
POCUS examinations were performed by three emergency medicine residents who had completed a structured musculoskeletal POCUS training program consisting of theoretical and hands-on training followed by supervised ankle ultrasonography examinations. POCUS operators were blinded to radiographic findings at the time of ultrasound interpretation.
All participants underwent clinical assessment and three-view conventional radiography. Fracture status was determined using a prospectively defined composite reference standard. Radiographically confirmed fractures were classified as fracture-positive. Computed tomography was selectively performed in patients with negative or equivocal radiographs when persistent clinical concern warranted further imaging. Orthopedic assessment was incorporated into routine clinical care, and participants were prospectively tracked for 14 days for subsequent emergency department visits, additional imaging, or changes in management.
The diagnostic performance of POCUS was evaluated using sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios, overall diagnostic accuracy, and the area under the receiver operating characteristic curve.
- Conditions
- Pediatric Ankle Fracture
- Being tested
- Point-of-Care Ultrasonography (POCUS)
- Keywords
- Point-of-Care Ultrasonography, Pediatric Ankle Trauma, Diagnostic Accuracy, Physeal Fracture, Salter-Harris Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care Ultrasonography (POCUS)Diagnostic test
Bedside point-of-care ultrasonography (POCUS) of the injured ankle was performed before conventional radiography using a high-frequency linear transducer (5-15 MHz). The distal tibia, distal fibula, talus, calcaneus, and navicular were systematically evaluated in longitudinal and transverse planes, with particular attention to the region of maximal tenderness. POCUS was classified as positive when cortical discontinuity, step-off, or focal cortical irregularity compatible with fracture was identified and as negative when these findings were absent.
| Study group | Role | What they receive |
|---|---|---|
| Children With Acute Ankle Trauma | Children aged 5-17 years presenting to the emergency department with acute isolated ankle trauma and meeting at least one Ottawa Ankle Rule criterion. All participants underwent bedside point-of-care ultrasonography (POCUS) before conventional radiography. Fracture status was determined using a prospectively defined composite reference standard. Receives: Diagnostic Test: Point-of-Care Ultrasonography (POCUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of POCUS for Pediatric Ankle Fracture Detection
Diagnostic performance of point-of-care ultrasonography (POCUS) for detecting ankle fractures was assessed against the prospectively defined composite reference standard. Performance measures included sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and overall diagnostic accuracy, with 95% confidence intervals where applicable.
Measured: Index emergency department visit, with fracture status verified through 14 days
Secondary outcomes (1)
Anatomical Distribution of False-Positive POCUS Findings
The anatomical distribution of false-positive POCUS findings was assessed to evaluate whether open physeal anatomy contributed to incorrect fracture-positive ultrasound interpretations. False-positive examinations were defined as POCUS findings suggestive of fracture that were not confirmed as fractures by the composite reference standard. False-positive findings were categorized according to anatomical location, including physeal and non-physeal sites.
Measured: Index emergency department visit, with fracture status verified through 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jul 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Ankle FractureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Utku Murat Kalafat, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Ömer Kepir, Principal investigator, University of Health Sciences, Başakşehir Çam and Sakura City HospitalUtku Murat Kalafat, md, Study director, University of Health Sciences, Istanbul Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872124
- Sponsor's protocol ID
- 2024.07.152 / KAEK/2024.07.152
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results may be made available to qualified researchers upon reasonable request to the corresponding author, subject to applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ultrasonography for Pediatric Ankle Fracture Detection: High Sensitivity But Reduced Specificity Around Open Physes
- ClinicalTrials.gov ID
- NCT07872124
- Acronym / sponsor ID
- 2024.07.152 / KAEK/2024.07.152
- Conditions
- Pediatric Ankle Fracture
- Keywords
- Point-of-Care Ultrasonography, Pediatric Ankle Trauma, Diagnostic Accuracy, Physeal Fracture, Salter-Harris Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 13 Oct 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.
This prospective observational study evaluated the diagnostic accuracy of point-of-care ultrasonography (POCUS) for detecting ankle fractures in children presenting to the emergency department with acute isolated ankle trauma. Children aged 5-17 years who met at least one Ottawa Ankle Rule criterion were included.
The primary objective was to determine how accurately bedside POCUS identifies pediatric ankle fractures compared with a predefined reference standard. The study also evaluated whether the presence of open growth plates influenced ultrasound interpretation.
Detailed description
This was a prospective, single-center observational diagnostic accuracy study conducted in the emergency department of a tertiary academic referral hospital. Consecutive children presenting with acute isolated ankle trauma were screened for eligibility. Participants were eligible if they were 5-17 years of age and fulfilled at least one Ottawa Ankle Rule criterion.
All POCUS examinations were performed before radiographic imaging using a high-frequency linear transducer. The distal tibia, distal fibula, talus, calcaneus, and navicular were systematically evaluated in longitudinal and transverse planes, with particular attention to the region of maximal tenderness. A POCUS examination was considered positive when cortical discontinuity, step-off, or focal cortical irregularity compatible with fracture was identified and negative when these findings were absent.
POCUS examinations were performed by three emergency medicine residents who had completed a structured musculoskeletal POCUS training program consisting of theoretical and hands-on training followed by supervised ankle ultrasonography examinations. POCUS operators were blinded to radiographic findings at the time of ultrasound interpretation.
All participants underwent clinical assessment and three-view conventional radiography. Fracture status was determined using a prospectively defined composite reference standard. Radiographically confirmed fractures were classified as fracture-positive. Computed tomography was selectively performed in patients with negative or equivocal radiographs when persistent clinical concern warranted further imaging. Orthopedic assessment was incorporated into routine clinical care, and participants were prospectively tracked for 14 days for subsequent emergency department visits, additional imaging, or changes in management.
The diagnostic performance of POCUS was evaluated using sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios, overall diagnostic accuracy, and the area under the receiver operating characteristic curve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Acute Ankle Trauma | – | Diagnostic Test: Point-of-Care Ultrasonography (POCUS)Children aged 5-17 years presenting to the emergency department with acute isolated ankle trauma and meeting at least one Ottawa Ankle Rule criterion. All participants underwent bedside point-of-care ultrasonography (POCUS) before conventional radiography. Fracture status was determined using a prospectively defined composite reference standard. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consisted of pediatric patients presenting with acute ankle trauma to the emergency department of a tertiary academic referral hospital. Consecutive patients were screened for study eligibility during the study period. The study focused on children for whom ankle radiography was clinically indicated according to the Ottawa Ankle Rules.
Key inclusion criteria (4 listed)
- Age 5-17 years
- Presentation to the emergency department with acute isolated ankle trauma
- Fulfillment of at least one Ottawa Ankle Rule criterion
- Written informed consent provided by the participant's legal guardian
Key exclusion criteria (7 listed)
- Polytrauma
- Penetrating ankle injury
- Clinically obvious deformity requiring immediate reduction
- Previous surgery to the affected ankle
- Inability to undergo point-of-care ultrasonography (POCUS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-Care Ultrasonography (POCUS)Bedside point-of-care ultrasonography (POCUS) of the injured ankle was performed before conventional radiography using a high-frequency linear transducer (5-15 MHz). The distal tibia, distal fibula, talus, calcaneus, and navicular were systematically evaluated in longitudinal and transverse planes, with particular attention to the region of maximal tenderness. POCUS was classified as positive when cortical discontinuity, step-off, or focal cortical irregularity compatible with fracture was identified and as negative when these findings were absent. | Diagnostic test | Children With Acute Ankle Trauma |
Primary outcome
Diagnostic Accuracy of POCUS for Pediatric Ankle Fracture Detection
Time frame: Index emergency department visit, with fracture status verified through 14 days
Diagnostic performance of point-of-care ultrasonography (POCUS) for detecting ankle fractures was assessed against the prospectively defined composite reference standard. Performance measures included sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and overall diagnostic accuracy, with 95% confidence intervals where applicable.
1 secondary outcome
Anatomical Distribution of False-Positive POCUS Findings
Time frame: Index emergency department visit, with fracture status verified through 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results may be made available to qualified researchers upon reasonable request to the corresponding author, subject to applicable ethical and institutional requirements.
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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. This study is not recruiting at the moment.
Ömer Kepir principal investigator
University of Health Sciences, Başakşehir Çam and Sakura City Hospital
Utku Murat Kalafat, md study director
University of Health Sciences, Istanbul Kanuni Sultan Suleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Ankle Fracture, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of POCUS for Pediatric Ankle Fracture Detection (time frame: Index emergency department visit, with fracture status verified through 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.