Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain

Decathlon

Status: Enrolling

Conditions: Epicondylitis; Elbow Sprain

Treatments: Other: Control group Elbow STRAP; Device: Elbow STRAP; Device: Elbow MID 500; Other: Control group Elbow MID 500

Study type: Observational

Funder types: Industry

Identifiers

NCT05552209

elbowMID500-STRAP

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

Orthosis group 1

Description:

Use of Elbow Mid 500 device during sport practice

Treatment:

Device: Elbow MID 500

Control group 1

Description:

Control group of the Elbow Mid 500 group - no medical device used during sport practice

Treatment:

Other: Control group Elbow MID 500

Orthosis group 2

Description:

Use of Elbow Strap device during sport practice

Treatment:

Device: Elbow STRAP

Control group 2

Description:

Control group of the Elbow Strap group - no medical device used during sport practice

Treatment:

Other: Control group Elbow STRAP