Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
Decathlon has developed kneeMID500-STRONG700 products which are two medical devices designed
 to be used for sport resumption after knee sprain.

 kneeMID500 device is intended to be used following a mild knee sprain. STRONG700 device is
 intended to be used following a moderate knee sprain.

 The difference between these devices is based on the strength of compression and the knee
 maintain.

 The objective of this multicentre study is to collect data on the related clinical
 complications and clinical outcomes of market-approved Decathlon kneeMID500-STRONG700
 products to demonstrate safety and performance of these devices in a real-world setting.
Inclusion Criteria:

 -  Subject is aged ≥18 years old

 -  Subject has a recent mild (grade I) OR moderate (grade II) knee sprain

 -  The current condition of his/her knee 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 (18 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 (knee 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, elastodiene)

 -  Adult subject to a legal protection measure