Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice

Study Overview
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Brief Summary
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Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device 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 ElbowSoft300 device and support peer-reviewed publications on products performance and safety.

Official Title
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Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice

Conditions
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Epicondylitis, Tendonitis Elbow, Elbow Injury

Intervention / Treatment
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* Device: Elbow SOFT 300
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is aged ≥ 18 years old Subject has a chronic epicondylitis (>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (>3 months) The current condition of his/her elbow allows the subject to continue 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 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, elastodiene, polyester, elastane) 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

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthosis group<br>Use of Elbow Soft 300 device during sport practice | Device: Elbow SOFT 300<br>* 15 patients will be included in this group and will used the medical device ElbowSOFT 300 during sport practice (at least 2 sport sessions per week), for 6 weeks.<br>|
| Other: Control group<br>No medical device used during sport practice | Other: Control group<br>* 15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device), 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 |
| --- | --- | --- |
| Functionnal score | Comparison of the Patient Rated Elbow Evaluation (20-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control) | 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 (6-item questionnaire with a global score from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control) | 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) | Change from Baseline elbow pain at 6 weeks | 
| Elbow instability | Comparison of elbow instability, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control) | Change from Baseline elbow instability at 6 weeks | 
| Safety (adverse events) | Comparison of adverse events rates between the groups (orthosis vs control) | 6 weeks of follow-up |