Clinical trial NCT05552235: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Epicondylitis
Tendonitis Elbow
Elbow Injury
Lead sponsor: Decathlon SE
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Functionnal score
timeFrame: Change from Baseline functionnal score at 6 weeks
Secondary outcomes:
measure: Confidence level (confidence questionnaire related to physical activity)
timeFrame: Change from Baseline confidence level at 6 weeks
measure: Elbow pain
timeFrame: Change from Baseline elbow pain at 6 weeks
measure: Elbow instability
timeFrame: Change from Baseline elbow instability at 6 weeks
measure: Safety (adverse events)
timeFrame: 6 weeks of follow-up
Other outcomes:
Locations:
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne-sur-Mer
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
Study officials:
affiliation: Centre Hospitalier Universitaire de Lille
name: Valérie WIECZOREK
role: PRINCIPAL_INVESTIGATOR
References: