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Assessment of the Safety and Performance of a Patellofemoral Brace

Primary Purpose

Patellofemoral Pain Syndrome, Patellar Instability

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
kneeSOFT500
Sponsored by
Decathlon SE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patellofemoral Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de rééducation et de balnéothérapie Kinés FachesRecruiting
  • Physio Sport LevalloisRecruiting
  • Centre Hospitalier Universitaire de LilleRecruiting
  • Cabinet de kinésithérapie du Belvédère

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Orthosis Group

Control Group

Arm Description

Use of kneeSOFT500 device

No use of the device

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Knee instability
Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control)
Knee pain
Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control)
Safety (adverse events)
Comparison of adverse events rates between the groups (orthosis vs control)

Full Information

First Posted
September 4, 2020
Last Updated
September 12, 2022
Sponsor
Decathlon SE
Collaborators
EFOR, France
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1. Study Identification

Unique Protocol Identification Number
NCT04653753
Brief Title
Assessment of the Safety and Performance of a Patellofemoral Brace
Official Title
Assessment of the Safety and Performance of a Patellofemoral Brace
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Decathlon SE
Collaborators
EFOR, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Patellar Instability

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orthosis Group
Arm Type
Experimental
Arm Description
Use of kneeSOFT500 device
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No use of the device
Intervention Type
Device
Intervention Name(s)
kneeSOFT500
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional score
Description
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)
Time Frame
18 weeks of follow-up
Secondary Outcome Measure Information:
Title
Confidence level
Description
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)
Time Frame
At baseline and 18 weeks of follow-up
Title
Knee instability
Description
Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control)
Time Frame
At 6 weeks, 12 weeks and 18 weeks of follow-up
Title
Knee pain
Description
Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control)
Time Frame
At 6 weeks, 12 weeks and 18 weeks of follow-up
Title
Safety (adverse events)
Description
Comparison of adverse events rates between the groups (orthosis vs control)
Time Frame
18 weeks of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean HEE
Phone
XX XX XX XX XX
Email
jean.hee@btwin.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie WIECZOREK
Organizational Affiliation
Centre Hospitalier Universitaire de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de rééducation et de balnéothérapie Kinés Faches
City
Faches-Thumesnil
ZIP/Postal Code
59155
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loïc RAUSENBERGER
First Name & Middle Initial & Last Name & Degree
Loïc RAUSENBERGER
Facility Name
Physio Sport Levallois
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément OUDART
First Name & Middle Initial & Last Name & Degree
Clément OUDART
Facility Name
Centre Hospitalier Universitaire de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie WIECZOREK
First Name & Middle Initial & Last Name & Degree
Valérie WIECZOREK
Facility Name
Cabinet de kinésithérapie du Belvédère
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte QUATRHOMME
First Name & Middle Initial & Last Name & Degree
Charlotte QUATRHOMME

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of the Safety and Performance of a Patellofemoral Brace

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