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

Primary Purpose

Epicondylitis, Tendonitis Elbow, Elbow Injury

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Elbow SOFT 300

Control group

About this trial

This is an interventional treatment trial for Epicondylitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Centre Hospitalier de Boulogne-sur-MerRecruiting
Centre Hospitalier Universitaire de Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Orthosis group

Control group

Arm Description

Use of Elbow Soft 300 device during sport practice

No medical device used during sport practice

Outcomes

Primary Outcome Measures

Functionnal score

Comparison of the Patient Rated Elbow Evaluation (20-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control)

Secondary Outcome Measures

Confidence level (confidence questionnaire related to physical activity)

Gap in the confidence level related to physical activity (6-item questionnaire with a global score from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control)

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)

Elbow instability

Comparison of elbow instability, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control)

Safety (adverse events)

Comparison of adverse events rates between the groups (orthosis vs control)

Full Information

NCT ID

NCT05552235

First Posted

September 13, 2022

Last Updated

January 13, 2023

Sponsor

Decathlon SE

1. Study Identification

Unique Protocol Identification Number

NCT05552235

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2022 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Decathlon SE

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epicondylitis, Tendonitis Elbow, Elbow Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Orthosis group

Arm Type

Experimental

Arm Description

Use of Elbow Soft 300 device during sport practice

Arm Title

Control group

Arm Type

Other

Arm Description

No medical device used during sport practice

Intervention Type

Device

Intervention Name(s)

Elbow SOFT 300

Intervention Description

15 patients will be included in this group and will used the medical device ElbowSOFT 300 during sport practice (at least 2 sport sessions per week), for 6 weeks.

Intervention Type

Other

Intervention Name(s)

Control group

Intervention Description

15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device), for at least 2 sport sessions per week during 6 weeks.

Primary Outcome Measure Information:

Title

Functionnal score

Description

Time Frame

Change from Baseline functionnal score at 6 weeks

Secondary Outcome Measure Information:

Title

Confidence level (confidence questionnaire related to physical activity)

Description

Time Frame

Change from Baseline confidence level at 6 weeks

Title

Elbow pain

Description

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)

Time Frame

Change from Baseline elbow pain at 6 weeks

Title

Elbow instability

Description

Comparison of elbow instability, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control)

Time Frame

Change from Baseline elbow instability at 6 weeks

Title

Safety (adverse events)

Description

Comparison of adverse events rates between the groups (orthosis vs control)

Time Frame

6 weeks of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean HEE

Phone

07 64 35 00 45

Ext

+33

jean.hee@btwin.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie TALLON

stallon@soladis.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valérie WIECZOREK

Organizational Affiliation

Centre Hospitalier Universitaire de Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier de Boulogne-sur-Mer

City

Boulogne-sur-Mer

ZIP/Postal Code

62200

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoann MORVAN

y.morvan@ch-boulogne.fr

First Name & Middle Initial & Last Name & Degree

Yoann MORVAN

Facility Name

Centre Hospitalier Universitaire de Lille

City

Lille

ZIP/Postal Code

59000

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valérie WIECZOREK

valerie.wieczorek@chru-lille.fr

First Name & Middle Initial & Last Name & Degree

Valérie WIECZOREK

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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