UnknownNot Applicable

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

France60 participantsStarted 2021-03-05

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional score

Timeframe: At baseline and 18 weeks of follow-up

Trial details

NCT IDNCT04592471

SponsorDecathlon SE

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12

Contact for this trial

Jean HEE

XX XX XX XX XX jean.hee@btwin.com

View on ClinicalTrials.gov More Knee Sprain (Mild) trials