TerminatedNot Applicable

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

Stopped: Difficulties of inclusion, financial considerations, review of CER (no additional clinical data needed to demonstrate safety and performance of the medical device under evaluation)

France7 participantsStarted 2021-03-25

Plain-language summary

Decathlon has developed kneeSOFT100 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 kneeSOFT100 product to demonstrate safety and performance of this device in a real-world setting.

Who can participate

Age range18 Years

SexALL

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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 chronic pain AND / OR chronic knee instability * 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 (6 weeks) * Subject is affiliated to the French social security regime Exclusion 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) 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 (elastodiene, polyester) * Adult subject to a legal protection measure

What they're measuring

Functional score

Timeframe: 6 weeks of follow-up

Trial details

NCT IDNCT04601168

SponsorDecathlon SE

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-07-19