Assessment of the Safety and Performance of a Patellofemoral Brace

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Safety and Performance of a Patellofemoral Brace

Conditions
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Patellofemoral Pain Syndrome, Patellar Instability

Intervention / Treatment
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* Device: kneeSOFT500


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthosis Group<br>Use of kneeSOFT500 device | Device: kneeSOFT500<br>* 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.<br>|
| No Intervention: Control Group<br>No use of the device | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional score | 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) | 18 weeks of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confidence level | 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) | At baseline and 18 weeks of follow-up | 
| Knee instability | Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control) | At 6 weeks, 12 weeks and 18 weeks of follow-up | 
| Knee pain | Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control) | At 6 weeks, 12 weeks and 18 weeks of follow-up | 
| Safety (adverse events) | Comparison of adverse events rates between the groups (orthosis vs control) | 18 weeks of follow-up |