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| Name | Class |
|---|---|
| EFOR, France | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthosis group 1 | Use of Elbow Mid 500 device during sport practice |
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| Control group 1 | Control group of the Elbow Mid 500 group - no medical device used during sport practice |
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| Orthosis group 2 | Use of Elbow Strap device during sport practice |
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| Control group 2 | Control group of the Elbow Strap group - no medical device used during sport practice |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elbow MID 500 | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with acute epicondylitis (stage 1 or 2) or a recent mild elbow sprain whose current condition of their elbow allows them to pursue a usual physical activity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean HEE | Contact | 07 64 35 00 45 | +33 | jean.hee@btwin.com |
| Sophie TALLON | Contact | stallon@soladis.fr |
| Name | Affiliation | Role |
|---|---|---|
| Valérie WIECZOREK | Centre Hospitalier Universitaire de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Boulogne sur Mer | Recruiting | Boulogne-sur-Mer | 62200 | France |
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| Control group Elbow MID 500 | Other | 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. |
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| Elbow STRAP | Device | 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. |
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| Control group Elbow STRAP | Other | 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. |
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| 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 |
| Centre de rééducation et de balnéothérapie Kinés Faches | Recruiting | Faches-Thumesnil | 59155 | France |
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| Centre Hospitalier Universitaire de Lille | Not yet recruiting | Lille | 59000 | France |
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| Cabinet de kinésithérapie du Belvédère | Not yet recruiting | Paris | 75019 | France |
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