- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05552235
Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean HEE
- Phone Number: +33 07 64 35 00 45
- Email: jean.hee@btwin.com
Study Contact Backup
- Name: Sophie TALLON
- Email: stallon@soladis.fr
Study Locations
-
-
-
Boulogne-sur-Mer, France, 62200
- Recruiting
- Centre Hospitalier de Boulogne-sur-mer
-
Contact:
- Yoann MORVAN
- Email: y.morvan@ch-boulogne.fr
-
Principal Investigator:
- Yoann MORVAN
-
Lille, France, 59000
- Not yet recruiting
- Centre Hospitalier Universitaire de Lille
-
Principal Investigator:
- Valérie WIECZOREK
-
Contact:
- Valérie WIECZOREK
- Email: valerie.wieczorek@chru-lille.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orthosis group
Use of Elbow Soft 300 device during sport practice
|
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.
|
Other: Control group
No medical device used during sport practice
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functionnal score
Time Frame: Change from Baseline functionnal score at 6 weeks
|
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)
|
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 (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)
|
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)
|
Change from Baseline elbow pain at 6 weeks
|
Elbow instability
Time Frame: Change from Baseline elbow instability at 6 weeks
|
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)
|
Change from Baseline elbow instability at 6 weeks
|
Safety (adverse events)
Time Frame: 6 weeks of follow-up
|
Comparison of adverse events rates between the groups (orthosis vs control)
|
6 weeks of follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Valérie WIECZOREK, Centre Hospitalier Universitaire de Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- elbowSOFT300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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Clinical Trials on Elbow SOFT 300
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