An observational study in Pediatric Ankle Fracture, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational
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.
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.
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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.
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Exclusion Criteria:
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.
Diagnostic Test: 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 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.
Time frame: Index emergency department visit, with fracture status verified through 14 days
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.
Time frame: Index emergency department visit, with fracture status verified through 14 days
Plan to share: 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.
Supporting information: Informed consent form
Time frame: Data will be available following publication of the study results and will remain available for a period determined by applicable institutional data-retention policies.
Access criteria: De-identified individual participant data may be provided to qualified researchers who submit a reasonable scientific request to the corresponding author. Requests will be considered based on the proposed research purpose and compliance with applicable ethical, institutional, and data-protection requirements. Data will be shared only when the requested use is compatible with participant consent and institutional policies.
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