Fractures, BoneUFracNCT04501510
Ultrasonography in Fracture Management
An observational study of Fractures, Bone and Upper Extremity Injury, run by University of Warmia and Mazury at 1 site in Poland.
Trial summary
The bone fracture is usually diagnosed using an X-ray examination (the method of choice). However, in the case of the youngest patients (children and adolescents), it carries a potential risk of X-ray radiation exposure. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Fractures, Bone, Upper Extremity Injury, Healing Fracture of Bone
- What is being tested?
- Ultrasonographic examination validation and testing
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 2 Nov 2020to Jul 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 50 patients admitted to the Orhopaedics and Trauma Ward of Prof. dr Stanislaw Popowski Regional Specialized Children's Hospital in Olsztyn, Poland with trauma to the upper extremity (from the proximal of the wrist to distal of the glenohumeral joint with evidence of pain, tenderness or swelling of the limb). Patients will be devided into two groups of radius or humerus bone (RadiusFracture and HumerusFracture groups). All patients will be recruited starting from July 2020. In all patients, first ultrasound and then standard plain radiography will be performed.
Who may be able to join
- the proximal end of the humerus and the distal end of the radius bones fractures
- voluntary participation and consent to participate in the study signed by the parent and patient
- declaration of participation in an X-ray and ultrasound examination during all 8 weeks post-injury
- no medical contraindications to participate in the study program
Who cannot join
- previous injuries of a similar body area
- plaster immobilization
- fractures referred for surgery
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University of Warmia and Mazury in Olsztyn
Olsztyn, 10-719
Anna M Kamelska-Sadowska, PhD, +48 508-163-209, kamelskamedical@gmail.com
Anna M Kamelska-Sadowska, PhD
About this study
Official title: The Use of Ultrasonography as a Diagnostic Tool for the Fracture Management
The bone fracture is usually diagnosed using an X-ray examination (the method of choice). However, in the case of the youngest patients (children and adolescents), it carries a potential risk of X-ray radiation exposure. What is important, an X-ray examination often fails to detect occult fractures or the early stages of a fracture with or without bone fusion. The literature emphasizes that from 2 to 36% of fractures may be unnoticed on X-ray images (false negative results). Therefore, additional possibilities are sought to improve the initial diagnosis.
It was shown that ultrasound could be used instead of the conventional imaging. The most important advantages of the usg are the absence of radiation exposure and greater availability. Moreover, the evaluator is able to show neovascularization during usg examination, which is important in bone healing process.
Read more
The aim of this study is (1) to validate the ultrasound imaging method for the fracture management; (2) to use an ultrasound imaging to assess the bone fracture and healing process during 8 weeks post injury.
This study consists of 50 patients aged 10-18 years old. The forearm fracture will be diagnosed using an X-ray imaging as well as an ultrasound imaging in the first 3 days post injury (initial study). It is planned to assess the healing process after 2, 4, 6 and/or 8 weeks post injury (comparative study).
Read the detailed description
The physiological fracture healing is based on the proper facilitation of regeneration and proliferation process. The bone fracture is usually diagnosed using an X-ray examination. However, an ultrasound imaging could be used instead of the conventional imaging. It is important in the case of the youngest patients. In these cases, the Hubner protocol/algorithm is often used. The patients with suspected fracture are advised to perform an ultrasound examination. Only after the confirmation of a suspected fracture, an X-ray examination should be performed.
Bone structure show typical characteristics, which make an ultrasonography an attractive medical diagnostic tool. Highly dense tissues such as bone reflect echoes and, therefore, appear bright white on an ultrasound (reflection from the cortical surface of the bone). This allows bone to be clearly distinguished from the surrounding soft tissues.
It was shown that ultrasound is a good diagnostic tool to assess the fracture healing process. The advantage of usg is that it is non-invasive, does not use ionizing radiation and is performed in a real-time.
The first study about the ultrasound in the diagnosis of fracture was carried out in 1988 in a group of 41 newborns with suspected clavicle fractures after complicated delivery. In all cases, the collarbone fracture was easily identifiable by an ultrasound in the first few days after the injury. Moreover, these data correlated with the conventional X-ray imaging.
It was also shown that the ultrasound method in pediatric patients can be used to visualize fractures, e.g. of the ribs or the sternum. In the acute phase, disturbances in the cortical layer of the bone as well as recent hematoma are easily observed. In the later phase, the formation of a callus (callus hypertrophy) could be diagnosed.
The aim of this study is (1) to validate the ultrasound imaging method using variables such as repeatability, interclass correlation coefficient (Qw), relative standard deviation (rSD) etc.; (2) to use an ultrasound imaging to assess the bone fracture and healing process during 8 weeks post injury.
This study consists of 50 patients aged 10-18 years old. The forearm fracture will be diagnosed using an X-ray imaging as well as an ultrasound imaging in the first 3 days post injury (initial study). It is planned to assess the proper healing process after 2, 4, 6 and/or 8 weeks post injury (comparative study).
Ultrasound examination:
- the measurement of the humerus in two different projections (a-p and lateral). The distance from the acromion localized on the shoulder blade will be measured in order to repeat the examination in the same area.
- radial bone examination in two different projections (a-p and lateral). The distance from the radiocarpal joint space will be measured in order to repeat the examination in the same area.
- additionally, POWER Doppler assessment of callus neovascularization will be performed (each recording of the Doppler frame parameters for a given patient in order to repeat the examination at subsequent controls)
Experimental Design:
The fracture diagnosis is planned to be performed on the day of the injury, or at an interval of no more than 2-3 days post the injury as an initial examination and approx. during 8 weeks after the injury as a comparative examination (during the first control in an orthopedic clinic after 14 days, 4 weeks, 6 weeks and/or 8 weeks).
All the procedures performed in this study involving human participants will conform to the ethical guidelines of the 1975 Declaration of Helsinki (and its later amendments or comparable ethical standards, revised in 2013) and follow the Adapted Physical Activity (APA) Ethics Standard.
The protocol was approved by the Ethics Committee of Stanislaw Popowski Regional Specialized Children's Hospital in Olsztyn, Poland (number of approval: 6 ZE//2020/WSSD; date of approval: 22 May 2020).
The experiment will be conducted with the understanding of each subject. All subjects as well as their parents will give written informed consent before children's participation in this study.
- Being tested
- Ultrasonographic examination validation and testing
- Keywords
- ultrasonography, bone, fracture, x-ray, injury, upper extremity, humerus, radius, vascularization, Doppler
- Medical subject headings
- Fractures, Bone, Arm Injuries, Neovascularization, Pathologic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic examination validation and testingDiagnostic test
X-ray imaging as well as the ultrasonographic examination of the fracture and healing process in children will be performed. The validation of an usg will be done.
| Study group | Role | What they receive |
|---|---|---|
| HumerusFracture | Patients with humerus fracture Receives: Diagnostic Test: Ultrasonographic examination validation and testing | |
| RadiusFracture | Patients with radial bone fracture Receives: Diagnostic Test: Ultrasonographic examination validation and testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in fracture management using x-ray imaging and medical ultrasound within 8 weeks post-injury
The confirmation of fracture and healing process
Measured: through study completion, an average of 1 year
Mean Change from Baseline in adhesions development using medical ultrasound within 8 weeks post-injury
The assessment of the development of adhesions (changes in soft tissue image)
Measured: through study completion, an average of 1 year
Mean Change from Baseline in vascularization on POWER Doppler within 8 weeks post-injury
Mean Change from Baseline in vascularization on POWER Doppler within 8 weeks post-injury
Measured: through study completion, an average of 1 year
Mean Change from Baseline in Pain Scores on the Visual Analog Scale within 8 weeks post-injury
The changes in pain scale will be assessed using Visual Analogue Scale (VAS) and other specific for the selected injuries. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' (from mild to severe pain).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start2 Nov 2020
- Primary completionFeb 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fractures, BoneStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Malwina Kamelska-Sadowska, University of Warmia and Mazury
- Investigators
- Anna M Kamelska-Sadowska, PhD, Study chair, Department of Rehabilitation and Orthopedics, Collegium Medicum, Faculty of Medicine, University of Warmia and Mazury in Olsztyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501510
- Sponsor's protocol ID
- 61.610.022-110
- Acronym
- UFrac
- Status last verified
- Nov 2020
- First submitted
- 28 Jul 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maffulli N, Hughes T, Fixsen JA. Ultrasonographic monitoring of limb lengthening. J Bone Joint Surg Br. 1992 Jan;74(1):130-2. doi: 10.1302/0301-620X.74B1.1732241.
PubMed 1732241Cho KH, Lee SM, Lee YH, Suh KJ. Ultrasound diagnosis of either an occult or missed fracture of an extremity in pediatric-aged children. Korean J Radiol. 2010 Jan-Feb;11(1):84-94. doi: 10.3348/kjr.2010.11.1.84. Epub 2009 Dec 28.
PubMed 20046499Malahias MA, Manolopoulos PP, Kadu V, Shahpari O, Fagkrezos D, Kaseta MK. Bedside Ultrasonography for Early Diagnosis of Occult Radial Head Fractures in Emergency Room: A CT-Comparative Diagnostic Study. Arch Bone Jt Surg. 2018 Nov;6(6):539-546.
PubMed 30637310Hubner U, Schlicht W, Outzen S, Barthel M, Halsband H. Ultrasound in the diagnosis of fractures in children. J Bone Joint Surg Br. 2000 Nov;82(8):1170-3. doi: 10.1302/0301-620x.82b8.10087.
PubMed 11132281
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasonography as a Diagnostic Tool for the Fracture Management
- ClinicalTrials.gov ID
- NCT04501510
- Acronym / sponsor ID
- UFrac / 61.610.022-110
- Keywords
- ultrasonography, bone, fracture, x-ray, injury, upper extremity, humerus, radius
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Warmia and MazuryUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 6 Aug 2020 (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.
The bone fracture is usually diagnosed using an X-ray examination (the method of choice). However, in the case of the youngest patients (children and adolescents), it carries a potential risk of X-ray radiation exposure. What is important, an X-ray examination often fails to detect occult fractures or the early stages of a fracture with or without bone fusion. The literature emphasizes that from 2 to 36% of fractures may be unnoticed on X-ray images (false negative results). Therefore, additional possibilities are sought to improve the initial diagnosis.
It was shown that ultrasound could be used instead of the conventional imaging. The most important advantages of the usg are the absence of radiation exposure and greater availability. Moreover, the evaluator is able to show neovascularization during usg examination, which is important in bone healing process.
The aim of this study is (1) to validate the ultrasound imaging method for the fracture management; (2) to use an ultrasound imaging to assess the bone fracture and healing process during 8 weeks post injury.
This study consists of 50 patients aged 10-18 years old. The forearm fracture will be diagnosed using an X-ray imaging as well as an ultrasound imaging in the first 3 days post injury (initial study). It is planned to assess the healing process after 2, 4, 6 and/or 8 weeks post injury (comparative study).
Detailed description
The physiological fracture healing is based on the proper facilitation of regeneration and proliferation process. The bone fracture is usually diagnosed using an X-ray examination. However, an ultrasound imaging could be used instead of the conventional imaging. It is important in the case of the youngest patients. In these cases, the Hubner protocol/algorithm is often used. The patients with suspected fracture are advised to perform an ultrasound examination. Only after the confirmation of a suspected fracture, an X-ray examination should be performed.
Bone structure show typical characteristics, which make an ultrasonography an attractive medical diagnostic tool. Highly dense tissues such as bone reflect echoes and, therefore, appear bright white on an ultrasound (reflection from the cortical surface of the bone). This allows bone to be clearly distinguished from the surrounding soft tissues.
It was shown that ultrasound is a good diagnostic tool to assess the fracture healing process. The advantage of usg is that it is non-invasive, does not use ionizing radiation and is performed in a real-time.
The first study about the ultrasound in the diagnosis of fracture was carried out in 1988 in a group of 41 newborns with suspected clavicle fractures after complicated delivery. In all cases, the collarbone fracture was easily identifiable by an ultrasound in the first few days after the injury. Moreover, these data correlated with the conventional X-ray imaging.
It was also shown that the ultrasound method in pediatric patients can be used to visualize fractures, e.g. of the ribs or the sternum. In the acute phase, disturbances in the cortical layer of the bone as well as recent hematoma are easily observed. In the later phase, the formation of a callus (callus hypertrophy) could be diagnosed.
The aim of this study is (1) to validate the ultrasound imaging method using variables such as repeatability, interclass correlation coefficient (Qw), relative standard deviation (rSD) etc.; (2) to use an ultrasound imaging to assess the bone fracture and healing process during 8 weeks post injury.
This study consists of 50 patients aged 10-18 years old. The forearm fracture will be diagnosed using an X-ray imaging as well as an ultrasound imaging in the first 3 days post injury (initial study). It is planned to assess the proper healing process after 2, 4, 6 and/or 8 weeks post injury (comparative study).
Ultrasound examination:
- the measurement of the humerus in two different projections (a-p and lateral). The distance from the acromion localized on the shoulder blade will be measured in order to repeat the examination in the same area.
- radial bone examination in two different projections (a-p and lateral). The distance from the radiocarpal joint space will be measured in order to repeat the examination in the same area.
- additionally, POWER Doppler assessment of callus neovascularization will be performed (each recording of the Doppler frame parameters for a given patient in order to repeat the examination at subsequent controls)
Experimental Design:
The fracture diagnosis is planned to be performed on the day of the injury, or at an interval of no more than 2-3 days post the injury as an initial examination and approx. during 8 weeks after the injury as a comparative examination (during the first control in an orthopedic clinic after 14 days, 4 weeks, 6 weeks and/or 8 weeks).
All the procedures performed in this study involving human participants will conform to the ethical guidelines of the 1975 Declaration of Helsinki (and its later amendments or comparable ethical standards, revised in 2013) and follow the Adapted Physical Activity (APA) Ethics Standard.
The protocol was approved by the Ethics Committee of Stanislaw Popowski Regional Specialized Children's Hospital in Olsztyn, Poland (number of approval: 6 ZE//2020/WSSD; date of approval: 22 May 2020).
The experiment will be conducted with the understanding of each subject. All subjects as well as their parents will give written informed consent before children's participation in this study.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HumerusFracture | – | Diagnostic Test: Ultrasonographic examination validation and testingPatients with humerus fracture |
| RadiusFracture | – | Diagnostic Test: Ultrasonographic examination validation and testingPatients with radial bone fracture |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 50 patients admitted to the Orhopaedics and Trauma Ward of Prof. dr Stanislaw Popowski Regional Specialized Children's Hospital in Olsztyn, Poland with trauma to the upper extremity (from the proximal of the wrist to distal of the glenohumeral joint with evidence of pain, tenderness or swelling of the limb). Patients will be devided into two groups of radius or humerus bone (RadiusFracture and HumerusFracture groups). All patients will be recruited starting from July 2020. In all patients, first ultrasound and then standard plain radiography will be performed.
Key inclusion criteria (4 listed)
- the proximal end of the humerus and the distal end of the radius bones fractures
- voluntary participation and consent to participate in the study signed by the parent and patient
- declaration of participation in an X-ray and ultrasound examination during all 8 weeks post-injury
- no medical contraindications to participate in the study program
Key exclusion criteria (3 listed)
- previous injuries of a similar body area
- plaster immobilization
- fractures referred for surgery
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 |
|---|---|---|
| Ultrasonographic examination validation and testingX-ray imaging as well as the ultrasonographic examination of the fracture and healing process in children will be performed. The validation of an usg will be done. | Diagnostic test | HumerusFracture, RadiusFracture |
Primary outcome
Mean Change from Baseline in fracture management using x-ray imaging and medical ultrasound within 8 weeks post-injury
Time frame: through study completion, an average of 1 year
The confirmation of fracture and healing process
Mean Change from Baseline in adhesions development using medical ultrasound within 8 weeks post-injury
Time frame: through study completion, an average of 1 year
The assessment of the development of adhesions (changes in soft tissue image)
Mean Change from Baseline in vascularization on POWER Doppler within 8 weeks post-injury
Time frame: through study completion, an average of 1 year
Mean Change from Baseline in vascularization on POWER Doppler within 8 weeks post-injury
Mean Change from Baseline in Pain Scores on the Visual Analog Scale within 8 weeks post-injury
Time frame: through study completion, an average of 1 year
The changes in pain scale will be assessed using Visual Analogue Scale (VAS) and other specific for the selected injuries. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' (from mild to severe pain).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 1732241Maffulli N, Hughes T, Fixsen JA. Ultrasonographic monitoring of limb lengthening. J Bone Joint Surg Br. 1992 Jan;74(1):130-2. doi: 10.1302/0301-620X.74B1.1732241.
- Background: PubMed 20046499Cho KH, Lee SM, Lee YH, Suh KJ. Ultrasound diagnosis of either an occult or missed fracture of an extremity in pediatric-aged children. Korean J Radiol. 2010 Jan-Feb;11(1):84-94. doi: 10.3348/kjr.2010.11.1.84. Epub 2009 Dec 28.
- Background: PubMed 30637310Malahias MA, Manolopoulos PP, Kadu V, Shahpari O, Fagkrezos D, Kaseta MK. Bedside Ultrasonography for Early Diagnosis of Occult Radial Head Fractures in Emergency Room: A CT-Comparative Diagnostic Study. Arch Bone Jt Surg. 2018 Nov;6(6):539-546.
- Background: PubMed 11132281Hubner U, Schlicht W, Outzen S, Barthel M, Halsband H. Ultrasound in the diagnosis of fractures in children. J Bone Joint Surg Br. 2000 Nov;82(8):1170-3. doi: 10.1302/0301-620x.82b8.10087.
- Erik Beek and Rick R van Rijn (eds). Diagnostic Pediatric UltrasoundLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Anna M Kamelska-Sadowska, PhD study chair
Department of Rehabilitation and Orthopedics, Collegium Medicum, Faculty of Medicine, University of Warmia and Mazury in Olsztyn
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 Fractures, Bone and Upper Extremity Injury, run by University of Warmia and Mazury at 1 site in Poland.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Nov 2020. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna M Kamelska-Sadowska, PhD (+48 508163209, kamelskamedical@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in fracture management using x-ray imaging and medical ultrasound within 8 weeks post-injury (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04501510, which also lists 4 linked publications.
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 5 Nov 2020.