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

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Sprain (Mild), Knee Sprain (Moderate), Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Device: kneeMID500-STRONG700


Participation Criteria
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Eligibility Criteria
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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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orthosis Group 1<br>Use of kneeMID500 device | Device: kneeMID500-STRONG700<br>* At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (2 device types: Knee MID 500 and Knee STRONG 700) totalling 60 patients will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use a knee support device.<br>|
| Control Group 1<br>Control Group of the kneeMID500 Orthosis Group - No use of the device | |
| Orthosis Group 2<br>Use of kneeSTRONG700 device | Device: kneeMID500-STRONG700<br>* At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (2 device types: Knee MID 500 and Knee STRONG 700) totalling 60 patients will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use a knee support device.<br>|
| Control Group 2<br>Control Group of the kneeSTRONG700 Orthosis Group - No use of the device | |

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 ; Tegner Activity Scale: 11-level gradient) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model | At baseline and 18 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 in each group (orthosis vs control), for each device model | At baseline and 18 weeks of follow-up | 
| Knee instability | Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control), for each device model | At 6 weeks, 12 weeks and 18 weeks of follow-up | 
| Knee pain | Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control), for each device model | At 6 weeks, 12 weeks and 18 weeks of follow-up | 
| Safety (adverse events) | Comparison of adverse events rates between the groups (orthosis vs control), for each device model | 18 weeks of follow-up |