NCT04601168

Terminated

Assessment of the Safety and Performance of a Compression Kn...

Decathlon SE Source

Decathlon SE

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

kneeSOFT100

Study Type

observational

Actual enrollment (reported)

7

Locations

1 country

Sites

2

Timeline

Study Start

March 25, 2021

Actual (reported)

Primary Completion

July 19, 2022

Actual (reported)

Study Completion

July 19, 2022

Actual (reported)

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 7 participants
Study completion date: July 19, 2022
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 4, 2020
Actual (reported)
First Posted
October 23, 2020
Actual (reported)
Study Start
March 25, 2021
Actual (reported)
Primary Completion
July 19, 2022
Actual (reported)
Study Completion
July 19, 2022
Actual (reported)

Last Updated: September 14, 2022
Status Verified: September 2022
Last Update Submitted: September 12, 2022

Conditions

Chronic Instability of Knee Joint Chronic Knee Pain

Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

Confidence level
At baseline and 6 weeks of follow-up
Knee instability
At 2 weeks and 6 weeks of follow-up
Knee pain
At 2 weeks and 6 weeks of follow-up
Safety (adverse events)
6 weeks of follow-up

Interventions

kneeSOFT100Device

During the first two weeks of follow-up, the subject shall not use the device during the sports sessions. The subject shall use the device during the sports sessions for the next 4 weeks (6 weeks of follow-up)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Subject is aged ≥18 years old

Sponsors & Collaborators

Decathlon SE
Industrylead
EFOR, France
Industrycollaborator

Study Sites (2)

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

KOSS Paris 8

Paris, France

Study Officials

Valérie WIECZOREK
Centre Hospitalier Universitaire de Lille
PRINCIPAL INVESTIGATOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

October 23, 2020

Study Start

March 25, 2021

Actual (reported)

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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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

July 19, 2022

Actual (reported)

Study Completion

July 19, 2022

Actual (reported)

Last Updated

September 14, 2022

Record last verified: 2022-09

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04601168
Data provider: ClinicalTrials.gov
Source updated: 2022-09-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:08 UTC

Locations

FR(2)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations