Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
TerminatedNCT04601168
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
- Conditions
- Chronic Knee Pain
- Chronic Instability of Knee Joint
- Interventions
- Device: kneeSOFT100
- Sponsor
- Decathlon SE
- Collaborators
- EFOR, France
- Start date
- 2021-03-25
- Primary completion
- 2022-07-19
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04601168