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.
Study Type
OBSERVATIONAL
Enrollment
60
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.
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.
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.
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.
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer, France
RECRUITINGCentre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, France
RECRUITINGCentre Hospitalier Universitaire de Lille
Lille, France
NOT_YET_RECRUITINGCabinet de kinésithérapie du Belvédère
Paris, France
NOT_YET_RECRUITINGFunctional 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.
Time frame: Change from Baseline functionnal score at 6 weeks
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
Time frame: 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
Time frame: 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
Time frame: 6 weeks of follow-up
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