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The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were treated with osteotomy will not be treated with any SYSADOA after operation, even though their cartilage's not completely loss, so osteotomy plus HA injection should provide more benefit to patients than osteotomy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteotomy plus Hyalgan | Experimental | Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28 |
|
| Osteotomy alone | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate (Hyalgan) | Drug | 1% Sodium Hyaluronate in prefilled syringe |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Joint Space Width | 12 months | |
| Global assessment | assess by Patient and investigator | 12 months |
| WOMAC section A, B, C | Pain score | 12 months |
| Rescue medicine consumption | Diclofenac consumption | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital, Faculty of Medicine, Mahidol university | Bangkok | Bangkok | 10700 | Thailand |
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| Osteotomy alone |
| Procedure |
no injection |
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D010027 | Osteotomy |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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