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

January 13, 2023 updated by: Decathlon SE

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Boulogne-sur-Mer, France, 62200
        • Recruiting
        • Centre Hospitalier de Boulogne Sur Mer
        • Contact:
        • Principal Investigator:
          • Yoann MORVAN
      • Faches-Thumesnil, France, 59155
      • Lille, France, 59000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de LILLE
        • Principal Investigator:
          • Valérie WIECZOREK
        • Contact:
      • Paris, France, 75019
        • Not yet recruiting
        • Cabinet de kinésithérapie du Belvédère
        • Contact:
        • Principal Investigator:
          • Charlotte QUATRHOMME

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthosis group 1
Use of Elbow Mid 500 device during sport practice
Device: Elbow MID 500
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.
Control group 1
Control group of the Elbow Mid 500 group - no medical device used during sport practice
Other: Control group Elbow MID 500
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.
Orthosis group 2
Use of Elbow Strap device during sport practice
Device: Elbow STRAP
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.
Control group 2
Control group of the Elbow Strap group - no medical device used during sport practice
Other: Control group Elbow STRAP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional score
Time Frame: Change from Baseline functionnal score at 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confidence level (confidence questionnaire related to physical activity)
Time Frame: Change from Baseline confidence level at 6 weeks
Gap in the confidence level related to physical activity (scale from 0=worst outcome 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 confidence level at 6 weeks
Elbow pain
Time Frame: Change from Baseline elbow pain at 6 weeks
Comparison of elbow pain, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control), for each device model
Change from Baseline elbow pain at 6 weeks
Safety (adverse events)
Time Frame: 6 weeks of follow-up
Comparison of adverse events rates between the groups (orthosis vs control), for each device model
6 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Decathlon SE

Collaborators

EFOR, France

Investigators

  • Principal Investigator: Valérie WIECZOREK, Centre Hospitalier Universitaire de LILLE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • elbowMID500-STRAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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