Prospective Evaluation of Ultrasonographic Diagnostics for Monitoring Skeletal Fracture Healing in Pediatric Patients: A Comparative Study With Conventional Radiography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of the Pediatric Long-bone Ultrasound Score (PLUS) compared to conventional radiography
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Written informed consent from parent/legal guardian, with child assent when appropriate.
Exclusion Criteria
- •Fractures treated surgically, including internal or external fixation.
- •Pathological fractures.
- •Metabolic bone disease or known bone fragility disorder.
- •Severe polytrauma or unstable clinical condition.
- •Inability to complete follow-up or non-compliance with study procedures.
Arms & Interventions
Conservatively treated pediatric fractures
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.
Intervention: Point-of-care ultrasound (Other)
Outcomes
Primary Outcomes
Diagnostic accuracy of the Pediatric Long-bone Ultrasound Score (PLUS) compared to conventional radiography
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.
Secondary Outcomes
- Inter-rater reliability of the PLUS ultrasound score(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(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(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(Assessed at the routine follow-up visit when fracture union is anticipated, typically 3 to 8 weeks post-injury.)