Ankle TraumaANKLENCT03507972
Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of Injuries the Child's Ankle
A study testing ankle ultrasound and Member MRI in people with Ankle Trauma, run by University Hospital, Lille at 1 site in France.
Trial summary
Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI) Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Ankle Trauma
- What is being tested?
- ankle ultrasound and Member MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2016to 31 Jan 2020
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥ 5 years and < 18 years
- Isolated's trauma from one or both ankles
- First-line consultation for pediatrics emergencies at the University Hospital of Lille
- Informed and written consent of the holders of parental authority
Who cannot join
- Age < 5 years and ≥ 18 years
- History of trauma of the same ankle dating from less than 3 month
- History of surgery of this same ankle
- Constitutional or acquired bone disease
- Associated trauma affecting another anatomical region than the ankle or midfoot
- Polytrauma (presence of several traumas including at least one endangers vital functions)
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- Associated wound requiring surgical exploration
- initial management of this trauma in another center
- Non affiliation to a social security scheme
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de pédiatrie Générale, Urgences et Maladies Infectieuses, Pôle de l'Urgence, Hôpital Roger Salengro
Lille
About this study
Official title: Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of the Child's Traumatic Ankle Injuries
Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI)
- Conditions
- Ankle Trauma
- Being tested
- ankle ultrasound, Member MRI
- Keywords
- ankle, diagnostic, ankle's ultrasound, traumatic lesion
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankle ultrasoundRadiation
Ankle ultrasound performed during emergencies visit.
Member MRIRadiation
Member MRI (without injection of contrast product) performed within 7 days following the trauma
| Study group | Role | What they receive |
|---|---|---|
| Ankle ultrasound & ankle MRI | Other | Ankle ultrasound performed on the day of emergency consultation member MRI (without injection of contrast products) performed within 7 days following the trauma Receives: Radiation: ankle ultrasound; Radiation: Member MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance rate of anatomical lesions of the ankle of ultrasound
Sensitivity of ankle ultrasound compared to MRI, considered as a gold standard, in the diagnosis of traumatic ankle injuries
Measured: Baseline (inclusion)
Secondary outcomes (3)
Diagnostic performance rate of anatomical lesions
Specificity, predictive values (positive and negative) and likelihood ratios (positive and negative) of ultrasound versus MRI
Measured: Baseline (inclusion) and at visit 2 (within 7 days after the baseline)
The use of Ottawa decision rule
the place of Ottawa criteria and ultrasound in the decision algorithm to limit standard radiographs (and thus irradiation).
The Ottawa Ankle Rule was derived to aid in the efficient use of radiography in acute ankle and midfoot injuries.
Measured: baseline (inclusion)
orthopedic rehabilitation quality at 3 weeks according to the Oxford score.
The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is used to measure subjective well-being for child patients (aged 5-16) affected by foot and ankle conditions using issues that are considered important to children.
The OxAFQ-C has 15 items, 14 of which are used to calculate domain scores:
Physical (6 items); School and Play (4 items) Emotional (4 items)
Measured: at 3 weeks (control visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start25 Feb 2016
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Why it stopped: default inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Dubos, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507972
- Sponsor's protocol ID
- 2014_35
- Other IDs
- 2015-A01127-42
- Acronym
- ANKLE
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2018
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of the Child's Traumatic Ankle Injuries
- ClinicalTrials.gov ID
- NCT03507972
- Acronym / sponsor ID
- ANKLE / 2014_35
- Conditions
- Ankle Trauma
- Keywords
- ankle, diagnostic, ankle's ultrasound, traumatic lesion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: default inclusion
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 25 Apr 2018 (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.
Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle ultrasound & ankle MRI | Other | Radiation: ankle ultrasound, Radiation: Member MRIAnkle ultrasound performed on the day of emergency consultation member MRI (without injection of contrast products) performed within 7 days following the trauma |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age ≥ 5 years and < 18 years
- Isolated's trauma from one or both ankles
- First-line consultation for pediatrics emergencies at the University Hospital of Lille
- Informed and written consent of the holders of parental authority
Key exclusion criteria (9 listed)
- Age < 5 years and ≥ 18 years
- History of trauma of the same ankle dating from less than 3 month
- History of surgery of this same ankle
- Constitutional or acquired bone disease
- Associated trauma affecting another anatomical region than the ankle or midfoot
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 |
|---|---|---|
| ankle ultrasoundAnkle ultrasound performed during emergencies visit. | Radiation | Ankle ultrasound & ankle MRI |
| Member MRIMember MRI (without injection of contrast product) performed within 7 days following the trauma | Radiation | Ankle ultrasound & ankle MRI |
Primary outcome
Diagnostic performance rate of anatomical lesions of the ankle of ultrasound
Time frame: Baseline (inclusion)
Sensitivity of ankle ultrasound compared to MRI, considered as a gold standard, in the diagnosis of traumatic ankle injuries
3 secondary outcomes
Diagnostic performance rate of anatomical lesions
Time frame: Baseline (inclusion) and at visit 2 (within 7 days after the baseline)
The use of Ottawa decision rule
Time frame: baseline (inclusion)
orthopedic rehabilitation quality at 3 weeks according to the Oxford score.
Time frame: at 3 weeks (control visit)
Results and safety
The study was stopped early (reason given: default inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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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.
François Dubos, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ankle ultrasound and Member MRI in people with Ankle Trauma, run by University Hospital, Lille at 1 site in France.
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 9 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: stopped early, as of the sponsor's last update on 8 Dec 2025. 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 France. 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?
The study was stopped early (reason given: default inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance rate of anatomical lesions of the ankle of ultrasound (time frame: Baseline (inclusion)). 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 8 Dec 2025.