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

Recruiting

• Conditions: Elbow Sprain; Epicondylitis
• Interventions: Device: Elbow MID 500; Other: Control group Elbow STRAP; Other: Control group Elbow MID 500; Device: Elbow STRAP

• Registration Number: NCT05552209
• Lead Sponsor: Decathlon SE

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-20
• Study Start: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Orthosis group 1	Elbow MID 500	Use of Elbow Mid 500 device during sport practice
Control group 2	Control group Elbow STRAP	Control group of the Elbow Strap group - no medical device used during sport practice
Control group 1	Control group Elbow MID 500	Control group of the Elbow Mid 500 group - no medical device used during sport practice
Orthosis group 2	Elbow STRAP	Use of Elbow Strap device during sport practice

Primary Outcome Measures

Name	Time	Method
Functional score	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.

Secondary Outcome Measures

Name	Time	Method
Safety (adverse events)	6 weeks of follow-up	Comparison of adverse events rates between the groups (orthosis vs control), for each device model
Confidence level (confidence questionnaire related to physical activity)	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
Elbow pain	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

Trial Locations

Locations (4)

Cabinet de kinésithérapie du Belvédère; 🇫🇷 Paris, France

Centre Hospitalier de Boulogne sur Mer; 🇫🇷 Boulogne-sur-Mer, France

Centre de rééducation et de balnéothérapie Kinés Faches; 🇫🇷 Faches-Thumesnil, France

Centre Hospitalier Universitaire de Lille; 🇫🇷 Lille, France