Assessment of the Safety and Performance of a Patellofemoral Brace

Assessment of the Safety and Performance of a Patellofemoral Brace

Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT500 product to demonstrate safety and performance of this device in a real-world setting.

Inclusion Criteria:

• Subject is aged ≥18 years old
• Subject has patellofemoral syndrome
• The current condition of his/her knee allows the subject to keep a regular 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 (18 weeks)
• Subject is affiliated to the French social security regime

Non-Inclusion 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 (knee 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, cotton, elastane, elastodiene, polyester)
• Adult subject to a legal protection measure