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We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and placebo (NSS) controlled in a double-blind RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H group | Experimental | Single dose of Hyruan-One 3 mL intra-articular knee injection. |
|
| S group | Active Comparator | Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection. |
|
| N group | Placebo Comparator | Single dose of normal saline 6 mL intra-articular knee injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyruan-One | Drug | single dose intra-articular injection |
| |
| Hylan G-F 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level | visual analog scale for pain (0-100) in between groups | 6 months after injection |
| Change from pre-injection pain level at 6 months | compare visual analog scale for pain (0-100) between pre-injection and post-injection | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| pain level in any time pints | visual analog scale for pain (0-100) | post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks |
| Modified WOMAC | measure modified WOMAC score (0-96) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nattapol Tammachote, MD | Thammasat University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
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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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| ID | Term |
|---|---|
| C049816 | hylan |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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A double-blind, placebo controlled RCT
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| Drug |
single dose intra-articular injection |
|
|
| Normal saline | Drug | single dose intra-articular injection |
|
| post-injection 2 weeks, 1, 2, 3,4, 5, 6 months |
| Lequesne index | measure Lequesne index for knee osteoarthritis (4-24) | post-injection 2 weeks, 1, 2, 3,4, 5, 6 months |
| SF-36 | measure short from health survey 36 items | post-injection 2 weeks, 1, 2, 3,4, 5, 6 months |
| Time up and go test | recorded time Up and Go test (minutes) | post-injection 1, 3, 6 months |
| Complications | assess complications after injection by phone | post-injection 1, 2 weeks |
| D012216 |
| Rheumatic Diseases |