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To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyruan ONE® | Experimental |
| |
| Durolane® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyruan ONE® | Device | For use as a symptomatic treatment of osteoarthritis (OA) of the knee |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore | The WOMAC Likert Index measures 3 separate dimensions: pain, stiffness, and function. The subject will self assess the level of pain in the target knee joint for the prior 48 hours (5 questions), the level of difficulty of performing daily activities (17 questions), and the level of stiffness (2 questions) using the WOMAC Likert Questionnaire (24 total questions; 4 points/question). Each item of the WOMAC Likert Index will be assessed using the scale of 0=none, 1=a little, 2=moderate, 3=severe, 4=very severe. The aggregate total score that can result for each scale is as follows: Pain = 0-20 Stiffness = 0-8 Physical function = 0-68. | from Baseline to 13 weeks post injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lubelskie Centrum Diagnostyczne | Świdnik | 21-040 | Poland |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Durolane® |
| Device |
For use as a symptomatic treatment of osteoarthritis (OA) of the knee |
|