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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthosis group | Experimental | Use of Elbow Soft 300 device during sport practice |
|
| Control group | Other | No medical device used during sport practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elbow SOFT 300 | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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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| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | 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. |
|
| 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 |
| Centre Hospitalier Universitaire de Lille | Not yet recruiting | Lille | 59000 | France |
|
| D008722 | Methods |