Fractures BoneNCT05528432
ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
An observational study of Fractures Bone, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures Bone
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 30 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patient presenting to the emergency services of the CHU Saint Pierre
Who may be able to join
- Any adult patient with acute ankle trauma
- + one or more criteria of the Ottawa ankle rules :
- Inability to walk 4 steps immediately after the trauma or in the emergency room,
- pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone.
Who cannot join
- Any patient under the age of 18 years
- Any patient unable to sign the informed consent
- Skin lesions contraindicating sonography (e.g. open fracture wound, … )
- An unstable patient whose inclusion in the study would delay vital treatment
Trial locations and contacts
1 site in 1 country.
Alain PA Plumacker, Médecin contact
Belgium1 site, 1 recruiting
- Recruiting
FREZALS Laeticia Vaiana
Brussels, 1000
Laeticia Vaiana FL Frezals, Médecin, 02493481204 ext. 0032, laeticia.frezals@gmail.com
Alain PA Plumacker, Médecin, alain.plumacker@stpierre-bru.be
About this study
To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules
Read the detailed description
Selection of patients is according to the criteria detailed below. If the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. Besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter.
Care will be provided by the attending physician and, according to "standard of care", treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. Sonographic results will not be used for this purpose. All ankle x-ray series will be reviewed by a senior resident radiologist.
- Conditions
- Fractures Bone
- Keywords
- Fracture ankle, Fracture foot, Frature metatarsus, Ultrasound, X-ray
- Medical subject headings
- Fractures, Bone, Ankle Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value
Negative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures
Measured: at inclusion
Secondary outcomes (2)
Sensitivity
of ultrasound compared to standard radiography in the detection of long bone fractures
Measured: at inclusion
Specificity
of ultrasound compared to standard radiography in the detection of long bone fractures
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Feb 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laeticia Vaiana FL Frezals, Médecin, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528432
- Sponsor's protocol ID
- CE-21-02-21
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bozkurt O, Ersel M, Karbek Akarca F, Yalcinli S, Midik S, Kucuk L. The diagnostic accuracy of ultrasonography in determining the reduction success of distal radius fractures. Turk J Emerg Med. 2018 Aug 10;18(3):111-118. doi: 10.1016/j.tjem.2018.04.001. eCollection 2018 Sep.
PubMed 30191190Frezals LV, Delafontaine A, Scoubeau H, Sontou R, Moorthamers S, Plumacker A, Plumacker A. Diagnostic value of FAST ankle ultrasound compared to standard radiography for fracture detection in the emergency department by non-radiologist physicians: a monocentric prospective diagnostic cohort study. Eur J Trauma Emerg Surg. 2025 Feb 14;51(1):107. doi: 10.1007/s00068-025-02772-3.
PubMed 39953135
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
- ClinicalTrials.gov ID
- NCT05528432
- Acronym / sponsor ID
- CE-21-02-21
- Conditions
- Fractures Bone
- Keywords
- Fracture ankle, Fracture foot, Frature metatarsus, Ultrasound, X-ray
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 6 Sep 2022 (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.
To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules
Detailed description
Selection of patients is according to the criteria detailed below. If the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. Besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter.
Care will be provided by the attending physician and, according to "standard of care", treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. Sonographic results will not be used for this purpose. All ankle x-ray series will be reviewed by a senior resident radiologist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient presenting to the emergency services of the CHU Saint Pierre
Key inclusion criteria (4 listed)
- Any adult patient with acute ankle trauma
- Inability to walk 4 steps immediately after the trauma or in the emergency room,
- pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone.
Key exclusion criteria (4 listed)
- Any patient under the age of 18 years
- Any patient unable to sign the informed consent
- Skin lesions contraindicating sonography (e.g. open fracture wound, … )
- An unstable patient whose inclusion in the study would delay vital treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Negative predictive value
Time frame: at inclusion
Negative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures
2 secondary outcomes
Sensitivity
Time frame: at inclusion
Specificity
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Results publication: PubMed 30191190Bozkurt O, Ersel M, Karbek Akarca F, Yalcinli S, Midik S, Kucuk L. The diagnostic accuracy of ultrasonography in determining the reduction success of distal radius fractures. Turk J Emerg Med. 2018 Aug 10;18(3):111-118. doi: 10.1016/j.tjem.2018.04.001. eCollection 2018 Sep.
- Derived from this study: PubMed 39953135Frezals LV, Delafontaine A, Scoubeau H, Sontou R, Moorthamers S, Plumacker A, Plumacker A. Diagnostic value of FAST ankle ultrasound compared to standard radiography for fracture detection in the emergency department by non-radiologist physicians: a monocentric prospective diagnostic cohort study. Eur J Trauma Emerg Surg. 2025 Feb 14;51(1):107. doi: 10.1007/s00068-025-02772-3.
- Ferràs-Tarragó, J., Antequera-Cano, J.M., Català-de-las-Marinas, J. et al. Ankle torque-related fractures and its echo-fast diagnosis protocol. Eur J Trauma Emerg Surg 46, 801-805 (2020)Link provided by the sponsor.
- Doherty, C., Delahunt, E., Caulfield, B. et al. The Incidence and Prevalence of Ankle Sprain Injury: A Systematic Review and Meta-Analysis of Prospective Epidemiological Studies. Sports Med 44, 123-140 (2014)Link provided by the sponsor.
- Champagne N, Eadie L, Regan L, Wilson P. The effectiveness of ultrasound in the detection of fractures in adults with suspected upper or lower limb injury: a systematic review and subgroup meta-analysis. BMC Emergency Medicine 2019;19Link provided by the sponsor.
- Nelson BP, Chason K. Use of ultrasound by emergency medical services: a review. International Journal of Emergency Medicine 2008 12;1(4):253-259Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Fractures Bone
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
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.
Alain PA Plumacker, Médecin contact
Laeticia Vaiana FL Frezals, Médecin principal investigator
Centre Hospitalier Universitaire Saint Pierre
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, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 4 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 8 Sep 2022. 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 Belgium. 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 Laeticia Vaiana FL Frezals, Médecin (0493481204 ext. 0032, laeticia.frezals@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative predictive value (time frame: at inclusion). 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 NCT05528432, which also lists 2 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 8 Sep 2022.