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| Name | Class |
|---|---|
| EFOR, France | INDUSTRY |
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Decathlon has developed kneeMID500-STRONG700 products which are two medical devices designed to be used for sport resumption after mild (kneeMID500) or moderate (KneeSTRONG100) knee sprain or after an Anterior Cruciate Ligament surgery.
The difference between these devices is based on the strength of compression and the knee maintain.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeMID500-STRONG700 products to demonstrate safety and performance of these devices in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthosis Group 1 | Use of kneeMID500 device |
| |
| Control Group 1 | Control Group of the kneeMID500 Orthosis Group - No use of the device | ||
| Orthosis Group 2 | Use of kneeSTRONG700 device |
| |
| Control Group 2 | Control Group of the kneeSTRONG700 Orthosis Group - No use of the device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kneeMID500-STRONG700 | Device | At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (2 device types: Knee MID 500 and Knee STRONG 700) totalling 60 patients 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 (Lysholm Score: 0-100 points ; Tegner Activity Scale: 11-level gradient) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model | At baseline and 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), for each device model | At baseline and 18 weeks of follow-up |
| Knee instability |
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Inclusion Criteria:
Non-inclusion Criteria:
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Subject with a recent mild (grade I) OR moderate (grade II) knee sprain OR an ACL surgery whose current condition of his/her knee allows the subject to resume usual physical activity.
| 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 |
|---|---|
| D008224 | Lymphoma, Follicular |
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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), for each device model |
| 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), for each device model | 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), for each device model | 18 weeks of follow-up |
| Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59000 | France |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |