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It is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cingal® | Experimental | Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide |
|
| Monovisc® | Active Comparator | Single 4 ml intra-articular injection of Sodium Hyaluronate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide) | Device | Intra-articular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the local pain reduction after a single injection of Cingal® or Monovisc® over a 6 weeks period in patients with osteoarthritis of the knee assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the maximum pain reduction by treatment arm | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection |
| Compare the time to maximum pain reduction by treatment arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohit Bhandari, MD, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 04 | Barrie | Ontario | Canada | |||
| Site 03 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Monovisc® (Sodium hyaluronate) | Device | Intra-articular injection |
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
| 6 weeks post injection |
| Change in stiffness and physical function | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection |
| Overall change of WOMAC score | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection |
| Time to maximum WOMAC score reduction | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 weeks post injection |
| Hamilton |
| Ontario |
| Canada |
| Site 02 | Kanata | Ontario | Canada |
| Site 05 | Laval | Quebec | Canada |
| Site 01 | Québec | Quebec | Canada |
| D012216 |
| Rheumatic Diseases |