Chronic Knee PainNCT04601168
Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
An observational study of Chronic Knee Pain and Chronic Instability of Knee Joint, run by Decathlon SE at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Knee Pain, Chronic Instability of Knee Joint
- What is being tested?
- kneeSOFT100
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Mar 2021to 19 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Lille
Lille, 59000
KOSS Paris 8
Paris
About this study
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.
- Being tested
- kneeSOFT100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional score
Comparison of the functional result (Lysholm Score: 0-100 points) between the baseline and last follow-up visit
Measured: 6 weeks of follow-up
Secondary outcomes (4)
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
Measured: 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)
Measured: 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)
Measured: At 2 weeks and 6 weeks of follow-up
Safety (adverse events)
Rate of adverse events occurred during the study
Measured: 6 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start25 Mar 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Why it stopped: Difficulties of inclusion, financial considerations, review of CER (no additional clinical data needed to demonstrate safety and performance of the medical device under evaluation)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Decathlon SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Responsible party
- Sponsor
- Investigators
- Valérie WIECZOREK, Principal investigator, Centre Hospitalier Universitaire de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601168
- Sponsor's protocol ID
- kneeSOFT100
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
- ClinicalTrials.gov ID
- NCT04601168
- Acronym / sponsor ID
- kneeSOFT100
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulties of inclusion, financial considerations, review of CER (no additional clinical data needed to demonstrate safety and performance of the medical device under evaluation)
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Decathlon SEIndustry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kneeSOFT100During 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) | Device | – |
Primary outcome
Functional score
Time frame: 6 weeks of follow-up
Comparison of the functional result (Lysholm Score: 0-100 points) between the baseline and last follow-up visit
4 secondary outcomes
Confidence level
Time frame: At baseline and 6 weeks of follow-up
Knee instability
Time frame: At 2 weeks and 6 weeks of follow-up
Knee pain
Time frame: At 2 weeks and 6 weeks of follow-up
Safety (adverse events)
Time frame: 6 weeks of follow-up
Results and safety
The study was stopped early (reason given: Difficulties of inclusion, financial considerations, review of CER (no additional clinical data needed to demonstrate safety and performance of the medical device under evaluation)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie WIECZOREK principal investigator
Centre Hospitalier Universitaire de Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Knee Pain and Chronic Instability of Knee Joint, run by Decathlon SE at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties of inclusion, financial considerations, review of CER (no additional clinical data needed to demonstrate safety and performance of the medical device under evaluation)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional score (time frame: 6 weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.