NCT04114552

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

October 2, 2019

Last Update Submit

September 17, 2020

Conditions

Keywords

inversion traumaAnkle sprainphysical examinationtherapyrecurrence

Outcome Measures

Primary Outcomes (1)

  • Rate of patients who received a five days post injury new clinical assessment

    at 6 weeks

Secondary Outcomes (3)

  • Oral questionnaires

    At 6 weeks

  • Rate of patients receiving physiotherapy

    At 6 weeks

  • Rate of patients with recurrence

    At 6 weeks

Interventions

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

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who consulted at Tourcoing emergency department for an ankle sprain

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ch Tourcoing

Tourcoing, France

Location

MeSH Terms

Conditions

Ankle InjuriesRecurrence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hacène MOUSSOUNI, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 3, 2019

Study Start

October 15, 2019

Primary Completion

January 7, 2020

Study Completion

January 7, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations