Assessment of the Safety and Performance of Ankle 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 Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence. The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). The differences between the devices is based on the strength of compression and the ankle maintain. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Ankle STRONG 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 Ankle Ligament Supports in the Context of a Return to Sport After Sprain

Conditions
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Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree

Intervention / Treatment
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* Device: AnkleSTRONG100/500/900


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 OR moderate OR serious ankle sprain The current condition of his/her ankle 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 (12 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 (ankle 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, polyester, cotton) Adult subject to 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 AnkleSTRONG100 device | Device: AnkleSTRONG100/500/900<br>* At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (3 device types: Ankle STRONG 100/500/900) totalling 90 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 an ankle support device.<br>|
| Control Group 1<br>Control Group of the AnkleSTRONG100 Orthosis Group - No use of the device | |
| Orthosis Group 2<br>Use of AnkleSTRONG500 device | Device: AnkleSTRONG100/500/900<br>* At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (3 device types: Ankle STRONG 100/500/900) totalling 90 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 an ankle support device.<br>|
| Control Group 2<br>Control Group of the AnkleSTRONG500 Orthosis Group - No use of the device | |
| Orthosis Group 3<br>Use of AnkleSTRONG900 device | Device: AnkleSTRONG100/500/900<br>* At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (3 device types: Ankle STRONG 100/500/900) totalling 90 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 an ankle support device.<br>|
| Control Group 3<br>Control Group of the AnkleSTRONG900 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 (Karlsson Ankle Function Score, 0-100 points) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model | 12 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 12 weeks of follow-up | 
| Ankle instability | Comparison of ankle instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control), for each device model | At 4 weeks, 8 weeks and 12 weeks of follow-up | 
| Ankle pain | Comparison of ankle pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control), for each device model | At 4 weeks, 8 weeks and 12 weeks of follow-up | 
| Safety (adverse events) | Comparison of adverse events rates between the groups (orthosis vs control), for each device model | 12 weeks of follow-up |