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

Last updated: January 13, 2023
Sponsor: Decathlon SE
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tennis Elbow

Treatment

N/A

Clinical Study ID

NCT05552209
elbowMID500-STRAP
  • Ages 18-99
  • All Genders

Study 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

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 perweek)
  • The current condition of his/her elbow allows the subject to resume usual physicalactivity
  • 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 centerfor all clinical evaluations and required follow-up (6 weeks)
  • Subject is affiliated to the French social security regime

Exclusion

Exclusion Criteria:

  • Subject has conditions that may interfere with his/her ability to understand protocolrequirements, participate in scheduled visits, or provide his/her informed consent
  • Subject has worn a support (elbow brace or articulated orthosis) in the last monthduring 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'sdiscretion
  • Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, polyester, elastodiene) • Adult subject to legal protectionmeasure

Study Design

Total Participants: 60
Study Start date:
September 21, 2022
Estimated Completion Date:
October 31, 2023

Connect with a study center

  • Centre Hospitalier de Boulogne sur Mer

    Boulogne-sur-Mer, 62200
    France

    Active - Recruiting

  • Centre de rééducation et de balnéothérapie Kinés Faches

    Faches-Thumesnil, 59155
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Lille

    Lille, 59000
    France

    Site Not Available

  • Cabinet de kinésithérapie du Belvédère

    Paris, 75019
    France

    Site Not Available

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