Last updated: January 13, 2023
Sponsor: Decathlon SE
Overall Status: Active - Recruiting
Phase
N/A
Condition
Sprains
Tendon Injuries
Treatment
N/AClinical Study ID
NCT05552235
elbowSOFT300
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject is aged ≥ 18 years old
- Subject has a chronic epicondylitis (>3 months) OR elbow pain associated withtendonitis OR chronic elbow instability (>3 months)
- The current condition of his/her elbow allows the subject to continue usual physicalactivity
- 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 centerfor all clinical evaluations and required follow-up (6 weeks)
- Subject is affiliated to the French social security regime
Exclusion
Exclusion Criteria:
- Subject has conditions that may interfere with his/her ability to understand protocolrequirements, participate in scheduled visits, or provide his/her informed consent
- Subject has worn a support (elbow brace or articulated orthosis) in the last monthduring his/her sport practice
- Subject has any medical condition that could impact the study at investigator'sdiscretion
- Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, polyester, elastane)
- Adult subject to legal protection measure
Study Design
Total Participants: 30
Study Start date:
November 15, 2022
Estimated Completion Date:
March 31, 2023
Connect with a study center
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, 62200
FranceActive - Recruiting
Centre Hospitalier Universitaire de Lille
Lille, 59000
FranceSite Not Available
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