Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain
1 other identifier
observational
60
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2022
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2022
CompletedStudy Start
First participant enrolled
September 21, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedJanuary 17, 2023
January 1, 2023
1 year
September 13, 2022
January 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Confidence level (confidence questionnaire related to physical activity)
Change from Baseline confidence level at 6 weeks
Elbow pain
Change from Baseline elbow pain at 6 weeks
Safety (adverse events)
6 weeks of follow-up
Study Arms (4)
Orthosis group 1
Use of Elbow Mid 500 device during sport practice
Control group 1
Control group of the Elbow Mid 500 group - no medical device used during sport practice
Orthosis group 2
Use of Elbow Strap device during sport practice
Control group 2
Control group of the Elbow Strap group - no medical device used during sport practice
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Decathlon SElead
- EFOR, Francecollaborator
Study Sites (4)
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer, 62200, France
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, 59155, France
Centre Hospitalier Universitaire de Lille
Lille, 59000, France
Cabinet de kinésithérapie du Belvédère
Paris, 75019, France
Study Officials
- PRINCIPAL INVESTIGATOR
Valérie WIECZOREK
Centre Hospitalier Universitaire de Lille
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2022
First Posted
September 23, 2022
Study Start
September 21, 2022
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share