Bone FracturesUSG-FRACTHEALNCT07755787
Ultrasound Assessment of Pediatric Fracture Healing With the PLUS Score
An observational study of Bone Fractures, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 14 years
- Conditions the study is for
- Bone Fractures
- What is being tested?
- Point-of-care ultrasound
- How many people
- 1,200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
University Hospital Hradec Kralove
Hradec Králové, Czech Republic, 50005
Tomáš Merkl, M.D., Ph.D., +420724290230, merkl.tomas5@gmail.com
Peter Kraus, M.D., +420495833227, peter.kraus1@fnhk.cz
About this study
Official title: Prospective Evaluation of Ultrasonographic Diagnostics for Monitoring Skeletal Fracture Healing in Pediatric Patients: A Comparative Study With Conventional Radiography
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.
Read the 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.
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.
- Conditions
- Bone Fractures
- Being tested
- Point-of-care ultrasound
- Keywords
- Ultrasound, Ultrasonography, Point-of-care ultrasound, POCUS, Pediatrics, Long bone, PLUS score, Pediatric traumatology, Radiation-free imaging
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Point-of-care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at the routine follow-up visit when fracture union is anticipated, typically 3 to 8 weeks post-injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Sponsor
- Investigators
- Tomáš Merkl, M.D., Ph.D., Principal investigator, University Hospital Hradec Králové
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755787
- Sponsor's protocol ID
- 202602 P17
- Acronym
- USG-FRACTHEAL
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Ultrasonographic Diagnostics for Monitoring Skeletal Fracture Healing in Pediatric Patients: A Comparative Study With Conventional Radiography
- ClinicalTrials.gov ID
- NCT07755787
- Acronym / sponsor ID
- USG-FRACTHEAL / 202602 P17
- Conditions
- Bone Fractures
- Keywords
- Ultrasound, Ultrasonography, Point-of-care ultrasound, POCUS, Pediatrics, Long bone, PLUS score, Pediatric traumatology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conservatively treated pediatric fractures | – | Other: Point-of-care ultrasoundPediatric 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. |
Who may qualify
- Ages
- 0 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care ultrasoundAdditional 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. | Other | Conservatively treated pediatric fractures |
Primary outcome
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.
4 secondary outcomes
Inter-rater reliability of the PLUS ultrasound score
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
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
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
Time frame: Assessed at the routine follow-up visit when fracture union is anticipated, typically 3 to 8 weeks post-injury.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomáš Merkl, M.D., Ph.D. principal investigator
University Hospital Hradec Králové
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Fractures, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomáš Merkl, M.D., Ph.D. (+420724290230, tomas.merkl@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.