Clinical trial NCT04599829: Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain
Official title: Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ankle Sprain 1St Degree
Ankle Sprain 2Nd Degree
Ankle Sprain 3Rd Degree
Lead sponsor: Decathlon SE
Sponsor class: INDUSTRY
Collaborators: name: EFOR, France
First posted: 2020-10-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with ankle sprain whose current condition of his/her ankle allows the subject to resume usual physical activity

Brief summary: Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence.

The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). The differences between the devices is based on the strength of compression and the ankle maintain.

The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Ankle STRONG products to demonstrate safety and performance of these devices in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Subject is aged ≥ 18 years old
* Subject has a recent mild OR moderate OR serious ankle sprain
* The current condition of his/her ankle allows the subject to resume usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks)
* Subject is affiliated to the French social security regime

Non-inclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (ankle brace or articulated orthosis) since his/her recent injury
* Subject has resumed regular physical activity since his/her recent injury
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, polyester, cotton)
* Adult subject to legal protection measure

Primary outcomes:
measure: Functional score
timeFrame: 12 weeks of follow-up
Secondary outcomes:
measure: Confidence level
timeFrame: At baseline and 12 weeks of follow-up
measure: Ankle instability
timeFrame: At 4 weeks, 8 weeks and 12 weeks of follow-up
measure: Ankle pain
timeFrame: At 4 weeks, 8 weeks and 12 weeks of follow-up
measure: Safety (adverse events)
timeFrame: 12 weeks of follow-up
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
Study officials:
affiliation: Centre Hospitalier Universitaire de Lille
name: Valérie WIECZOREK
role: PRINCIPAL_INVESTIGATOR
References: