Clinical trial NCT05552209: Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain
Official title: Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epicondylitis
Elbow Sprain
Lead sponsor: Decathlon SE
Sponsor class: INDUSTRY
Collaborators: name: EFOR, France
First posted: 2022-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

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 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

Primary outcomes:
measure: Functional score
timeFrame: Change from Baseline functionnal score at 6 weeks
Secondary outcomes:
measure: Confidence level (confidence questionnaire related to physical activity)
timeFrame: Change from Baseline confidence level at 6 weeks
measure: Elbow pain
timeFrame: Change from Baseline elbow pain at 6 weeks
measure: Safety (adverse events)
timeFrame: 6 weeks of follow-up
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne sur Mer
city: Faches-Thumesnil
country: France
facility: Centre de rééducation et de balnéothérapie Kinés Faches
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Paris
country: France
facility: Cabinet de kinésithérapie du Belvédère
Study officials:
affiliation: Centre Hospitalier Universitaire de Lille
name: Valérie WIECZOREK
role: PRINCIPAL_INVESTIGATOR
References: