Patellofemoral Pain SyndromeNCT04653753
Assessment of the Safety and Performance of a Patellofemoral Brace
A study testing kneeSOFT500 in people with Patellofemoral Pain Syndrome and Patellar Instability, run by Decathlon SE at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellofemoral Pain Syndrome, Patellar Instability
- What is being tested?
- kneeSOFT500
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Mar 2021to Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, 59155
Loïc RAUSENBERGER
Loïc RAUSENBERGER
- Recruiting
Physio Sport Levallois
Levallois-Perret, 92300
Clément OUDART
Clément OUDART
- Recruiting
Centre Hospitalier Universitaire de Lille
Lille, 59000
Valérie WIECZOREK
Valérie WIECZOREK
- Not yet recruiting
Cabinet de kinésithérapie du Belvédère
Paris, 75019
Charlotte QUATRHOMME
Charlotte QUATRHOMME
About this study
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.
- Conditions
- Patellofemoral Pain Syndrome, Patellar Instability
- Being tested
- kneeSOFT500
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kneeSOFT500Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Orthosis Group | Experimental | Use of kneeSOFT500 device Receives: Device: kneeSOFT500 |
| Control Group | No intervention | No use of the device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 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 in each group (orthosis vs control)
Measured: At baseline and 18 weeks of follow-up
Knee instability
Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control)
Measured: At 6 weeks, 12 weeks and 18 weeks of follow-up
Knee pain
Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control)
Measured: At 6 weeks, 12 weeks and 18 weeks of follow-up
Safety (adverse events)
Comparison of adverse events rates between the groups (orthosis vs control)
Measured: 18 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 posted4 Dec 2020
- Study start2 Mar 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- NCT04653753
- Sponsor's protocol ID
- kneeSOFT500
- 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
- Individual data sharing
- 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 Patellofemoral Brace
- ClinicalTrials.gov ID
- NCT04653753
- Acronym / sponsor ID
- kneeSOFT500
- Conditions
- Patellofemoral Pain Syndrome, Patellar Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Decathlon SEIndustry (pharma, biotech, devices)
- Collaborators
- EFOR, France
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 Dec 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthosis Group | Experimental | Device: kneeSOFT500Use of kneeSOFT500 device |
| Control Group | No intervention | –No use of the device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| kneeSOFT500At 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. | Device | Orthosis Group |
Primary outcome
Functional score
Time frame: 18 weeks of follow-up
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)
4 secondary outcomes
Confidence level
Time frame: At baseline and 18 weeks of follow-up
Knee instability
Time frame: At 6 weeks, 12 weeks and 18 weeks of follow-up
Knee pain
Time frame: At 6 weeks, 12 weeks and 18 weeks of follow-up
Safety (adverse events)
Time frame: 18 weeks of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kneeSOFT500 in people with Patellofemoral Pain Syndrome and Patellar Instability, run by Decathlon SE at 4 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 12 inclusion and 0 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: status not confirmed, 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 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean HEE (XX XX XX XX XX, jean.hee@btwin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional score (time frame: 18 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.