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

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

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.

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