NCT Number: NCT07755787
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.
Trial opening soon.
Get Notified0 year–14 year
All sexes
Observational
Hradec Králové, Czech Republic, 50005, Czechia
Peter Kraus, M.D.
CONTACT
Peter Kraus, M.D.
SUB_INVESTIGATOR
Radek Štichhauer, M.D., Ph.D.
SUB_INVESTIGATOR
Tomáš Merkl, M.D., Ph.D.
CONTACT
Tomáš Merkl, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Zuzana Schröpfer, M.D.
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At the routine follow-up visit when fracture union is expected, usually 3 to 8 weeks after injury.
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: Assessed throughout the study period at the routine follow-up visit when fracture union is anticipated (typically 3 to 8 weeks post-injury).
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 from injury until documented fracture union, typically within 3 to 8 weeks post-injury, depending on fracture type and patient age.
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 at each routine outpatient follow-up visit during the study period, typically within 3 to 8 weeks after injury.
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 the routine follow-up visit when fracture union is anticipated, typically 3 to 8 weeks post-injury.
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.
Contact information is provided by the study sponsor or research team.
Peter Kraus, M.D.
CONTACT
Tomáš Merkl, M.D., Ph.D.
CONTACT
University Hospital Hradec Kralove
Other
Prospective Evaluation of Ultrasonographic Diagnostics for Monitoring Skeletal Fracture Healing in Pediatric Patients: A Comparative Study With Conventional Radiography
Acronym: USG-FRACTHEAL
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