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

Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552209
• Other study ID #: elbowMID500-STRAP
• Status: Recruiting
• Start date: September 21, 2022
• Est. completion date: October 2023

Study information

• Verified date: January 2023
• Source: Decathlon SE
• Contact: Jean HEE
• Phone: 07 64 35 00 45
• Email: jean.hee[@]btwin.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Elbow Sprain
• Epicondylitis
• Sprains and Strains
• Tennis Elbow

Intervention

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.

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.

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.

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.

Locations

Country	Name	City	State
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	Cabinet de kinésithérapie du Belvédère	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Decathlon SE	EFOR, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional score	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	Confidence level (confidence questionnaire related to physical activity)	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
Secondary	Elbow pain	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
Secondary	Safety (adverse events)	Comparison of adverse events rates between the groups (orthosis vs control), for each device model	6 weeks of follow-up