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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04114552
Other study ID # RNI_2019_23
Secondary ID 2019-A01824-53
Status Completed
Phase
First received
Last updated
Start date October 15, 2019
Est. completion date January 7, 2020

Study information

Verified date September 2020
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date January 7, 2020
Est. primary completion date January 7, 2020
Accepts healthy volunteers No
Gender All
Age group 15 Years to 55 Years
Eligibility 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 Design


Intervention

Other:
questionnaires
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

Locations

Country Name City State
France Ch Tourcoing Tourcoing

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of patients who received a five days post injury new clinical assessment at 6 weeks
Secondary Oral questionnaires The questionnaire will ask questions around their socio-demographic characteristics, trauma mechanism, medics management since they have left the emergency department. At 6 weeks
Secondary Rate of patients receiving physiotherapy At 6 weeks
Secondary Rate of patients with recurrence At 6 weeks
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