Ultrasound Assessment of Pediatric Fracture Healing With the PLUS Score

NCT07755787 | Not Yet Recruiting

• 1 other identifier: 202602 P17
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture Healing; Bone Fractures in Children

Keywords

Ultrasound; Ultrasonography; Point-of-care ultrasound; POCUS; Pediatrics; Long bone; PLUS score; Pediatric traumatology; Radiation-free imaging

Outcome Measures

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.

  At the routine follow-up visit when fracture union is expected, usually 3 to 8 weeks after injury.

Secondary Outcomes (4)

• 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.

Study Arms (1)

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.

Other: Point-of-care ultrasound

Interventions

Point-of-care ultrasound OTHER

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.

Conservatively treated pediatric fractures

Eligibility Criteria

• Age: 0 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead
• Masaryk University: collaborator

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, Czech Republic, 50005, Czechia

Location

Study Officials

• Tomáš Merkl, M.D., Ph.D.

  University Hospital Hradec Králové

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomáš Merkl, M.D., Ph.D.

CONTACT

+420724290230; tomas.merkl@fnhk.cz

Peter Kraus, M.D.

CONTACT

+420495833227; peter.kraus1@fnhk.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)