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Ultrasound Assessment of Pediatric Fracture Healing With the PLUS Score

ConditionBone Fractures
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-14
SponsorUniversity Hospital Hradec Kralove

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 0 to 14 years.

Acute fracture of a clavicle, sternum, patella, or long bone.

Conservative treatment planned or ongoing, including closed reduction and immobilization/casting.

Scheduled for routine outpatient follow-up with clinical and radiographic assessment.

Disqualifiers

Fractures treated surgically, including internal or external fixation.

Pathological fractures.

Metabolic bone disease or known bone fragility disorder.

Severe polytrauma or unstable clinical condition.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Point-of-care ultrasound

    Other intervention

    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.

Treatment groups

1,200 Participants
are divided into 1 treatment group
Group A: Conservatively treated pediatric fractures1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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).
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Hradec Kralove

Lead sponsor

Masaryk University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: