Patellar Instability, Patellofemoral Pain Syndrome
Conditions
Brief summary
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.
Interventions
DEVICEkneeSOFT500
At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use a knee support device.
Sponsors
EFOR, France
Decathlon SE
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional score | 18 weeks of follow-up | Comparison of the functional result (Kujala Anterior Knee Pain Scale, 0-100 points) between the baseline and last follow-up visit in each group (orthosis vs control) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confidence level | At baseline and 18 weeks of follow-up | Gap in the confidence level (patient rated outcome with 6 questions, ranging from 0 to 100) related to physical activity, between the baseline and last follow-up visit in each group (orthosis vs control) |
| Knee instability | At 6 weeks, 12 weeks and 18 weeks of follow-up | Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control) |
| Knee pain | At 6 weeks, 12 weeks and 18 weeks of follow-up | Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control) |
| Safety (adverse events) | 18 weeks of follow-up | Comparison of adverse events rates between the groups (orthosis vs control) |
Countries
France
Contacts
Primary ContactJean HEE
Outcome results
None listed