Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain (CHEVILLE)

September 17, 2020 updated by: University Hospital, Lille
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tourcoing, France
        • Ch Tourcoing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who consulted at Tourcoing emergency department for an ankle sprain

Description

Inclusion Criteria:

Consulted for ankle trauma as primary reason Agreeing to participate in the telephone survey 6 weeks after trauma Affiliation in a social security scheme

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients who received a five days post injury new clinical assessment
Time Frame: at 6 weeks
at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral questionnaires
Time Frame: At 6 weeks
The questionnaire will ask questions around their socio-demographic characteristics, trauma mechanism, medics management since they have left the emergency department.
At 6 weeks
Rate of patients receiving physiotherapy
Time Frame: At 6 weeks
At 6 weeks
Rate of patients with recurrence
Time Frame: At 6 weeks
At 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hacène MOUSSOUNI, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Actual)

January 7, 2020

Study Completion (Actual)

January 7, 2020

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RNI_2019_23
  • 2019-A01824-53 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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