Assessment of the Safety and Performance of a Patellofemoral Brace

Not Applicable

Recruiting

• Conditions: Patellofemoral Pain Syndrome; Patellar Instability
• Interventions: Device: kneeSOFT500

• Registration Number: NCT04653753
• Lead Sponsor: Decathlon SE

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-04
• Study Start: 2021-03-02
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-14
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthosis Group	kneeSOFT500	Use of kneeSOFT500 device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (4)

Centre de rééducation et de balnéothérapie Kinés Faches; 🇫🇷 Faches-Thumesnil, France

Cabinet de kinésithérapie du Belvédère; 🇫🇷 Paris, France

Physio Sport Levallois; 🇫🇷 Levallois-Perret, France

Centre Hospitalier Universitaire de Lille; 🇫🇷 Lille, France