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| Name | Class |
|---|---|
| EFOR, France | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthosis Group | Experimental | Use of kneeSOFT500 device |
|
| Control Group | No Intervention | No use of the device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kneeSOFT500 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 18 weeks of follow-up |
| 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 in each group (orthosis vs control) | At baseline and 18 weeks of follow-up |
| Knee instability |
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Inclusion Criteria:
Non-Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean HEE | Contact | XX XX XX XX XX | jean.hee@btwin.com |
| Name | Affiliation | Role |
|---|---|---|
| Valérie WIECZOREK | Centre Hospitalier Universitaire de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de rééducation et de balnéothérapie Kinés Faches | Recruiting | Faches-Thumesnil | 59155 | France |
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| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control) |
| 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) | 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) | 18 weeks of follow-up |
| Physio Sport Levallois | Recruiting | Levallois-Perret | 92300 | France |
|
| Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59000 | France |
|
| Cabinet de kinésithérapie du Belvédère | Not yet recruiting | Paris | 75019 | France |
|