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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Knee Pain, Chronic Instability of Knee Joint

Intervention / Treatment
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* Device: kneeSOFT100


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: kneeSOFT100|During the first two weeks of follow-up, the subject shall not use the device during the sports sessions. The subject shall use the device during the sports sessions for the next 4 weeks (6 weeks of follow-up)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional score | Comparison of the functional result (Lysholm Score: 0-100 points) between the baseline and last follow-up visit | 6 weeks of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confidence level | Gap in the confidence level (patient rated outcome with 6 questions, ranging from 0 to 100) related to physical activity, between the baseline and last follow-up visit | At baseline and 6 weeks of follow-up | 
| Knee instability | Comparison of knee instability between the first two weeks of follow-up (without use of the device during sports sessions) and the following four weeks (with use of the device during sports sessions), measured through a numerical rating scale (NRS, ranging from 0 to 10) | At 2 weeks and 6 weeks of follow-up | 
| Knee pain | Comparison of knee pain between the first two weeks of follow-up (without use of the device during sports sessions) and the following four weeks (with use of the device during sports sessions), measured through a NRS (ranging from 0 to 10) | At 2 weeks and 6 weeks of follow-up | 
| Safety (adverse events) | Rate of adverse events occurred during the study | 6 weeks of follow-up |