Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain

Study Overview
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Brief Summary
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Decathlon has developed elbowMID500 and elbowSTRAP products which are medical devices that must be positioned around the elbow during sport practice, in order to limit symptoms related to epicondylitis or previous sprains (elbowMID500 only). The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon elbowMID500 and elbowSTRAP products to demonstrate safety and performance of these devices in a real-world setting. Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon elbowMID500 and elbowSTRAP devices and support peer-reviewed publications on products performance and safety.

Official Title
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Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain

Conditions
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Epicondylitis, Elbow Sprain

Intervention / Treatment
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* Device: Elbow MID 500
* Other: Control group Elbow MID 500
* Device: Elbow STRAP
* Other: Control group Elbow STRAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is aged ≥ 18 years old Subject has an acute epicondylitis (stage 1 or 2) OR a recent mild elbow sprain Subject performs regular physical activity (minimum of 2 sessions of 10 minutes per week) The current condition of his/her elbow 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 (elbow brace or articulated orthosis) in the last month during his/her sport practice 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, elastodiene) • Adult subject to legal protection measure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

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 Elbow Mid 500 device during sport practice | Device: Elbow MID 500<br>* 15 patients will be included in this group and will used the medical device Elbow MID 500 during sport practice (at least 2 sport sessions per week), for 6 weeks.<br>|
| Control group 1<br>Control group of the Elbow Mid 500 group - no medical device used during sport practice | Other: Control group Elbow MID 500<br>* 15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow MID 500), for at least 2 sport sessions per week during 6 weeks.<br>|
| Orthosis group 2<br>Use of Elbow Strap device during sport practice | Device: Elbow STRAP<br>* 15 patients will be included in this group and will used the medical device Elbow STRAP during sport practice (at least 2 sport sessions per week), for 6 weeks.<br>|
| Control group 2<br>Control group of the Elbow Strap group - no medical device used during sport practice | Other: Control group Elbow STRAP<br>* 15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow STRAP), for at least 2 sport sessions per week during 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional score | Comparison of the Japanese Elbow Assessment Score System (JOA elbow scale from 0=worst ouctome to 100=best outcome) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model. | Change from Baseline functionnal score at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confidence level (confidence questionnaire related to physical activity) | Gap in the confidence level related to physical activity (scale from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control), for each device model | Change from Baseline confidence level at 6 weeks | 
| Elbow pain | Comparison of elbow pain, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control), for each device model | Change from Baseline elbow pain at 6 weeks | 
| Safety (adverse events) | Comparison of adverse events rates between the groups (orthosis vs control), for each device model | 6 weeks of follow-up |