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The aim of this study is to compare the safety and effectiveness between two BDDE-crosslinked hyaluronate, HYAJOINT Plus and Durolane, for the Treatment of Knee Osteoarthritis Pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYAJOINT Plus | Experimental |
| |
| Durolane | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYAJOINT Plus | Device | 60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline VAS pain score at 6 months post-injection. | The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain' | 6 months post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) score for pain change | The change from baseline VAS pain score at 1, 3, 9 and 12 months post-injection. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain' | Baseline, 1, 3, 9 and 12 months post-injection |
| Adverse events reported from the baseline and during the study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng-Kung University Hospital | Tainan | 704 | Taiwan |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Durolane |
| Device |
60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC. |
|
The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period. |
| 1, 3, 6, 9 and 12 months post-injection |
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change | The change from baseline WOMAC score at 1, 3, 6, 9 and 12 months post-injection. A 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes. | Baseline, 1, 3, 6, 9 and 12 months post-injection |
| Visual analog scale (VAS) score for stiffness change | The change from baseline VAS stiffness score at 1, 3, 6, 9 and 12 months post-injection. The VAS scale uses a 100 mm line labelled at '0' with 'no stiffness' and '100' with 'worst stiffness'. | Baseline, 1, 3, 6, 9 and 12 months post-injection |
| Visual analog scale (VAS) score for satisfaction change | The change from baseline VAS satisfaction score at 1, 3, 6, 9 and 12 months post-injection. Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'. | 1, 3, 6, 9 and 12 months post-injection |
| Timed Up-and-Go test (TUG) change | The change from baseline TUG time at 1, 3, 6, 9 and 12 months post-injection. A simple measurement of time in seconds for a subject to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down. | Baseline, 1, 3, 6, 9 and 12 months post-injection |
| Single-leg stance test (SLS) change | The change from baseline SLS time at 1, 3, 6, 9 and 12 months post-injection. A simple measurement of time in seconds for a subject raising one foot up without touching it to the supported lower extremity with knee OA and maintain balance for as long as possible. | Baseline, 1, 3, 6, 9 and 12 months post-injection |
| Knee joint inflammatory state change by ultrasonic inspection | The change from baseline of the subject knee inflammatory state at 1, 3, 6, 9 and 12 months post-injection through ultrasonic inspection. | Baseline, 1, 3, 6, 9 and 12 months post-injection |