Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice

Decathlon

Status: Enrolling

Conditions: Epicondylitis; Tendonitis Elbow; Elbow Injury

Treatments: Other: Control group; Device: Elbow SOFT 300

Study type: Interventional

Funder types: Industry

Identifiers

NCT05552235

elbowSOFT300

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is aged ≥ 18 years old
• Subject has a chronic epicondylitis (>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (>3 months)
• The current condition of his/her elbow allows the subject to continue 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 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, elastodiene, polyester, elastane)
• Adult subject to legal protection measure

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Orthosis group

Experimental group

Description:

Use of Elbow Soft 300 device during sport practice

Treatment:

Device: Elbow SOFT 300

Control group

Other group

Description:

No medical device used during sport practice

Treatment:

Other: Control group