Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice

Decathlon has developed kneeSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT100 product to demonstrate safety and performance of this device in a real-world setting.

Study Overview

• Status: Terminated
• Conditions: Chronic Knee Pain; Chronic Instability of Knee Joint
• Intervention / Treatment: Device: kneeSOFT100

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Centre Hospitalier Universitaire de Lille
  • Paris, France
    • KOSS Paris 8

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Subject with chronic pain AND / OR chronic knee instability whose current condition of his/her knee allows him/her to pursue a usual physical activity.

Description

Inclusion Criteria:

• Subject is aged ≥18 years old
• Subject has chronic pain AND / OR chronic knee instability
• The current condition of his/her knee allows the subject to resume usual 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 (6 weeks)
• Subject is affiliated to the French social security regime

Exclusion 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) during sports sessions during the last month
• 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 (elastodiene, polyester)
• Adult subject to a legal protection measure

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional score	Comparison of the functional result (Lysholm Score: 0-100 points) between the baseline and last follow-up visit	6 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	At baseline and 6 weeks of follow-up
Knee instability	Comparison of knee instability between the first two weeks of follow-up (without use of the device during sports sessions) and the following four weeks (with use of the device during sports sessions), measured through a numerical rating scale (NRS, ranging from 0 to 10)	At 2 weeks and 6 weeks of follow-up
Knee pain	Comparison of knee pain between the first two weeks of follow-up (without use of the device during sports sessions) and the following four weeks (with use of the device during sports sessions), measured through a NRS (ranging from 0 to 10)	At 2 weeks and 6 weeks of follow-up
Safety (adverse events)	Rate of adverse events occurred during the study	6 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 25, 2021
• Primary Completion (Actual): July 19, 2022
• Study Completion (Actual): July 19, 2022

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 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

• Other Study ID Numbers: kneeSOFT100

Drug and device information, study documents

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