Assessment of the Safety and Performance of a Patellofemoral Brace

Decathlon

Status

Enrolling

Conditions

Patellofemoral Pain Syndrome

Patellar Instability

Treatments

Device: kneeSOFT500

Study type

Interventional

Funder types

Industry

Identifiers

NCT04653753

kneeSOFT500

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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