Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
Study Details
Study Description
Brief Summary
Decathlon has developed kneeMID500-STRONG700 products which are two medical devices designed to be used for sport resumption after knee sprain.
kneeMID500 device is intended to be used following a mild knee sprain. STRONG700 device is intended to be used following a moderate knee sprain.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Orthosis Group 1 Use of kneeMID500 device |
Device: kneeMID500-STRONG700
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.
|
| Control Group 1 Control Group of the kneeMID500 Orthosis Group - No use of the device |
|
| Orthosis Group 2 Use of kneeSTRONG700 device |
Device: kneeMID500-STRONG700
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.
|
| Control Group 2 Control Group of the kneeSTRONG700 Orthosis Group - No use of the device |
Outcome Measures
Primary Outcome Measures
- Functional score [At baseline and 18 weeks of follow-up]
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
Secondary Outcome Measures
- Confidence level [At baseline and 18 weeks of follow-up]
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
- Knee instability [At 6 weeks, 12 weeks and 18 weeks of follow-up]
Comparison of knee instability, assessed through a visual analog scale (VAS, ranging from 0 to 10), between the groups (orthosis vs control), for each device model
- Knee pain [At 6 weeks, 12 weeks and 18 weeks of follow-up]
Comparison of knee pain, assessed through VAS (ranging from 0 to 10), between the groups (orthosis vs control), for each device model
- Safety (adverse events) [18 weeks of follow-up]
Comparison of adverse events rates between the groups (orthosis vs control), for each device model
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is aged ≥18 years old
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Subject has a recent mild (grade I) OR moderate (grade II) knee sprain
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The current condition of his/her knee allows the subject to resume usual physical activity
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Subject has been informed and is willing to sign an informed consent form
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Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (18 weeks)
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Subject is affiliated to the French social security regime
Non-inclusion Criteria:
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Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
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Subject has worn a support (knee brace or articulated orthosis) since his/her recent injury
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Subject has resumed regular physical activity since his/her recent injury
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Subject has any medical condition that could impact the study at investigator's discretion
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Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, elastodiene)
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Adult subject to a legal protection measure
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Decathlon SE
- EFOR, France
Investigators
- Principal Investigator: André THEVENON, Centre Hospitalier Régional, Universitaire de Lille
- Principal Investigator: Clément OUDART, Physio Sport Levallois
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- kneeMID500-STRONG700