Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice

Decathlon

Status

Enrolling

Conditions

Chronic Pain

Chronic Instability of Ankle Joint

Treatments

Device: ankleSOFT100

Study type

Interventional

Funder types

Industry

Identifiers

NCT04742088

ankleSOFT100

Details and patient eligibility

About

Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Subject is aged ≥18 years old
Subject has chronic pain AND / OR chronic ankle instability
The current condition of his/her ankle allows the subject to pursue a 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 (6 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) during sports sessions during the last month
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, elastodiene, elastane, polyester, synthetic rubber)
Adult subject to a legal protection measure