Ankle SprainsCHEVILLENCT04114552
Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain
An observational study of Ankle Sprains, run by University Hospital, Lille at 1 site in France.
Trial summary
Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. Therefore, an early management and follow up treatment is necessary. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2019to 7 Jan 2020
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who consulted at Tourcoing emergency department for an ankle sprain
Who may be able to join
- Consulted for ankle trauma as primary reason Agreeing to participate in the telephone survey 6 weeks after trauma Affiliation in a social security scheme
Who cannot join
- Patients deprived of liberty Patients with an unbalanced psychiatric disease If consultation delayed 48 hours due to trauma Patients with fracture Patients with Chopart or Lisfranc injury Pregnant women People who do not speak French
Trial locations and contacts
1 site in 1 country.
About this study
Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. Therefore, an early management and follow up treatment is necessary. Now, functional treatment is clinically the treatment strategy of choice for ankle sprain. It is based on rest, ice, compression, elevation and can use a functional support (like an ankle brace). To evaluate gravity and improve management, a clinical assessment delayed between 4 and 5 days post injury is necessary.
- Conditions
- Ankle Sprains
- Being tested
- questionnaires
- Keywords
- inversion trauma, Ankle sprain, physical examination, therapy, recurrence
- Medical subject headings
- Ankle Injuries, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
6 weeks after the trauma,during the call, an oral questionnaire will be proposed to collect data on patients' management since they have left the emergency department.
After the call, socio-demographic characteristics, trauma mechanism, medics management will be extracted from the patient's medical records
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who received a five days post injury new clinical assessment
Measured: at 6 weeks
Secondary outcomes (3)
Oral questionnaires
The questionnaire will ask questions around their socio-demographic characteristics, trauma mechanism, medics management since they have left the emergency department.
Measured: At 6 weeks
Rate of patients receiving physiotherapy
Measured: At 6 weeks
Rate of patients with recurrence
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start15 Oct 2019
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hacène MOUSSOUNI, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114552
- Sponsor's protocol ID
- RNI_2019_23
- Other IDs
- 2019-A01824-53
- Acronym
- CHEVILLE
- Status last verified
- Sep 2020
- First submitted
- 2 Oct 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain
- ClinicalTrials.gov ID
- NCT04114552
- Acronym / sponsor ID
- CHEVILLE / RNI_2019_23
- Conditions
- Ankle Sprains
- Keywords
- inversion trauma, Ankle sprain, physical examination, therapy, recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 3 Oct 2019 (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.
Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. Therefore, an early management and follow up treatment is necessary. Now, functional treatment is clinically the treatment strategy of choice for ankle sprain. It is based on rest, ice, compression, elevation and can use a functional support (like an ankle brace). To evaluate gravity and improve management, a clinical assessment delayed between 4 and 5 days post injury is necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who consulted at Tourcoing emergency department for an ankle sprain
Key inclusion criteria (1 listed)
- Consulted for ankle trauma as primary reason Agreeing to participate in the telephone survey 6 weeks after trauma Affiliation in a social security scheme
Key exclusion criteria (1 listed)
- Patients deprived of liberty Patients with an unbalanced psychiatric disease If consultation delayed 48 hours due to trauma Patients with fracture Patients with Chopart or Lisfranc injury Pregnant women People who do not speak French
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 |
|---|---|---|
| questionnaires6 weeks after the trauma,during the call, an oral questionnaire will be proposed to collect data on patients' management since they have left the emergency department. After the call, socio-demographic characteristics, trauma mechanism, medics management will be extracted from the patient's medical records | Other | – |
Primary outcome
Rate of patients who received a five days post injury new clinical assessment
Time frame: at 6 weeks
3 secondary outcomes
Oral questionnaires
Time frame: At 6 weeks
Rate of patients receiving physiotherapy
Time frame: At 6 weeks
Rate of patients with recurrence
Time frame: At 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
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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.
Hacène MOUSSOUNI, 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?
An observational study of Ankle Sprains, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of patients who received a five days post injury new clinical assessment (time frame: at 6 weeks). 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 21 Sep 2020.