An observational study in Bone Fractures, sponsored by University Hospital Hradec Kralove. Not yet recruiting at 1 site in Czechia. Open to participants aged 0 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University Hospital Hradec Kralove · Observational
This observational study investigates whether ultrasound can safely and accurately monitor the healing of bone fractures in children, comparing it to standard X-rays. Currently, children with fractures often require multiple X-rays during their recovery, which exposes them to small amounts of ionizing radiation. Ultrasound, on the other hand, is completely radiation-free.
The study aims to evaluate a specific ultrasound scoring system called the PLUS (Pediatric Long-bone Ultrasound Score) score. The study will include pediatric patients who are being treated conservatively (e.g., with a cast) for a long bone fracture, fractures of the sternum, patella and clavicle. During their regularly scheduled follow-up visits, participants will receive a brief ultrasound scan of the fracture site in addition to their standard clinical and X-ray examinations. The medical decisions regarding the patient's treatment will continue to be based entirely on standard care.
The main goal is to determine if the ultrasound PLUS score strongly correlates with the X-ray findings. If proven accurate, this scoring system could help reduce the need for routine X-rays in the future, thereby minimizing radiation exposure and potentially streamlining outpatient workflow.
Routine monitoring of pediatric fracture healing relies heavily on conventional radiography. While effective, it exposes growing children to cumulative ionizing radiation. Point-of-care ultrasound (POCUS) represents a promising, radiation-free, and easily accessible alternative for assessing callus formation and bone bridging. To standardize this ultrasound evaluation, specific scoring systems, such as the PLUS score, have been developed.
This prospective observational cohort study is designed to validate the clinical utility and diagnostic accuracy of the PLUS score in pediatric patients treated conservatively for long bone fractures, fractures of the sternum, patella and clavicle.
Methodology:
Patients presenting at the outpatient clinic with conservatively managed long bone fractures, fractures of the sternum, patella and clavicle will be consecutively enrolled. During their standard scheduled follow-up visits, patients will undergo routine care, including clinical evaluation and conventional radiography, to determine clinical and radiological union (e.g., indication for cast removal). Concurrently, an ultrasound examination will be performed to assess the fracture site and calculate the PLUS score.
The study is purely observational. The ultrasound findings will not alter the standard of care; all clinical decisions regarding treatment and immobilization removal will remain strictly based on standard clinical and radiographic assessments.
Data Collection and Analysis:
Patient demographics, injury details, time spent in the waiting room, radiological findings, and ultrasound PLUS scores will be prospectively recorded into a secure REDCap database provided by Masaryk University.
The primary objective is to evaluate the correlation between the PLUS score and the radiographic/clinical signs of bone union, ultimately determining the optimal cut-off value of the PLUS score that safely predicts sufficient healing. Secondary objectives include assessing the potential impact of ultrasound implementation on outpatient workflow efficiency and time management.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 130 across 239 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University Hospital Hradec Kralove is the lead sponsor of 49 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric patients aged 0 to 14 years with acute fractures of the clavicle, sternum, patella, or long bones managed conservatively with closed reduction and/or immobilization. Participants are recruited consecutively from the outpatient pediatric trauma clinic during routine follow-up visits. The study uses standard clinical care and radiographic assessment, with an additional observational ultrasound examination scored using the PLUS protocol. Surgical fractures, pathological fractures, metabolic bone disease, severe polytrauma, and non-compliance are excluded.
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.
Pediatric patients treated conservatively for a fracture of a long bone, clavicle, patella, or sternum. During their standard scheduled outpatient follow-up visits, participants will undergo routine clinical evaluation and conventional radiography to monitor bone healing. Concurrently, a point-of-care ultrasound (POCUS) examination of the fracture site will be performed to calculate the Pediatric Long-bone Ultrasound Score (PLUS). The ultrasound assessment is strictly observational and does not alter standard medical care or clinical decision-making.
Other: Point-of-care ultrasound
Additional ultrasound examination of the fracture site scored using the PLUS protocol, performed alongside standard clinical and radiographic follow-up. The ultrasound assessment is observational only and does not alter treatment decisions.
Diagnostic accuracy of the Pediatric Long-bone Ultrasound Score (PLUS) compared to conventional radiography
The primary outcome is the diagnostic accuracy of the ultrasound-based PLUS (Pediatric Long-bone Ultrasound Score) in identifying fracture union, compared with the reference standard of clinical assessment and conventional radiography. Accuracy will be quantified using sensitivity, specificity, positive and negative predictive values, and receiver operating characteristic (ROC) analysis to determine the optimal PLUS cut-off for safely declaring union.
Time frame: At the routine follow-up visit when fracture union is expected, usually 3 to 8 weeks after injury.
Inter-rater reliability of the PLUS ultrasound score
The degree of agreement between the primary examining pediatric surgeon and an independent blinded reviewer in assigning the PLUS ultrasound score will be assessed. Reliability will be quantified using appropriate agreement statistics (e.g., Cohen's kappa and intraclass correlation), to determine whether the PLUS protocol is reproducible between different raters.
Time frame: Assessed throughout the study period at the routine follow-up visit when fracture union is anticipated (typically 3 to 8 weeks post-injury).
Influence of biological sex and pubertal stage on fracture healing dynamics
The study will evaluate whether the temporal progression of sonographic fracture consolidation (PLUS score trajectories) differs according to biological sex and pubertal developmental stage. Time to union and PLUS score patterns will be compared between groups using appropriate survival and regression analyses, adjusting for age and fracture characteristics.
Time frame: Assessed from injury until documented fracture union, typically within 3 to 8 weeks post-injury, depending on fracture type and patient age.
Impact of ultrasound-based follow-up on outpatient workflow efficiency
Outpatient visit duration and waiting times will be recorded and compared between the standard radiography-based pathway and a simulated ultrasound-centered pathway. The outcome will be the difference in total time spent in the outpatient clinic and the proportion of visits in which routine control X-rays could be safely avoided based on PLUS findings.
Time frame: Assessed at each routine outpatient follow-up visit during the study period, typically within 3 to 8 weeks after injury.
Association between maximum callus thickness and fracture union
Maximum callus thickness measured on ultrasound will be explored as an auxiliary quantitative parameter and its relationship to clinical and radiographic fracture union will be assessed. This analysis is intended to determine whether a threshold value of callus thickness adds predictive value beyond the categorical PLUS score and whether it may refine interpretation of fracture healing.
Time frame: Assessed at the routine follow-up visit when fracture union is anticipated, typically 3 to 8 weeks post-injury.
Plan to share: No — Individual participant data will not be shared because the study contains pediatric clinical data and imaging information collected for a single-center observational project. Data will be stored in secured institutional systems and will be analyzed within the study team. Any publication will use aggregated, de-identified results only. At this time, no external data-sharing plan has been approved.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2030, 51 months later.
Of 66 non-industry observational studies under Fractures, Bone, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 88. This study's planned 51 months is above that.
Counting every sponsor, half of 86 studies reached it within 46 months; a quarter within 20 and three quarters within 124.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University Hospital Hradec Kralove