Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain

Decathlon

Status

Enrolling

Conditions

Knee Sprain (Mild)

Anterior Cruciate Ligament Tear

Knee Sprain (Moderate)

Treatments

Device: kneeMID500-STRONG700

Study type

Observational

Funder types

Industry

Identifiers

NCT04592471

kneeMID500-STRONG700

Details and patient eligibility

About

Decathlon has developed kneeMID500-STRONG700 products which are two medical devices designed to be used for sport resumption after mild (kneeMID500) or moderate (KneeSTRONG100) knee sprain or after an Anterior Cruciate Ligament surgery.

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.

Enrollment

60 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 a recent mild (grade I) OR moderate (grade II) knee sprain OR an ACL surgery
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