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.

Study Overview

• Status: Recruiting
• Conditions: Patellofemoral Pain Syndrome; Patellar Instability
• Intervention / Treatment: Device: kneeSOFT500

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean HEE; Phone Number: XX XX XX XX XX; Email: jean.hee@btwin.com

Study Locations

• France
  • Faches-Thumesnil, France, 59155
    • Recruiting
    • Centre de rééducation et de balnéothérapie Kinés Faches
    • Contact: Loïc RAUSENBERGER
    • Principal Investigator: Loïc RAUSENBERGER
  • Levallois-Perret, France, 92300
    • Recruiting
    • Physio Sport Levallois
    • Contact: Clément OUDART
    • Principal Investigator: Clément OUDART
  • Lille, France, 59000
    • Recruiting
    • Centre Hospitalier Universitaire de Lille
    • Contact: Valérie WIECZOREK
    • Principal Investigator: Valérie WIECZOREK
  • Paris, France, 75019
    • Not yet recruiting
    • Cabinet de kinésithérapie du Belvédère
    • Principal Investigator: Charlotte QUATRHOMME
    • Contact: Charlotte QUATRHOMME

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orthosis Group; Use of kneeSOFT500 device	Device: kneeSOFT500; 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.
No Intervention: Control Group; No use of the device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Decathlon SE
• Collaborators: EFOR, France
• Investigators: Principal Investigator: Valérie WIECZOREK, Centre Hospitalier Universitaire de Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: kneeSOFT500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No