Assessment of the Safety and Performance of a Patellofemoral Brace

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-02

Study Completion Date

2023-06-30

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.

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Detailed Description

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Conditions

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Patellofemoral Pain Syndrome Patellar Instability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Orthosis Group

Use of kneeSOFT500 device

Group Type EXPERIMENTAL

kneeSOFT500

Intervention Type DEVICE

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.

Control Group

No use of the device

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No