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Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation
Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Articular Lavage | Active Comparator | Patients from Group Zero will receive articular lavage with saline injection |
|
| Group 1 | Experimental | Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20 |
|
| Group 2 | Experimental | Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20 |
|
| Group 3 | Experimental | Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| articular lavage with saline injection | Procedure | Patients will receive articular lavage with saline injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC | Pain and function assessment with WOMAC questionaire | 6 months |
| VAS | Pain assessment with Visual Analogic Scale (VAS) | 6 months |
| Lequesne | Pain and function assessment with Lequesne questionaire | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
- Severe reaction to the procedure
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gustavo C de Campos, MD | Contact | +551983318000 | gustavoccampos@terra.com.br | |
| Marcia U Rezende, PhD | Contact | +5511981226282 | murezende@uol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Gustavo C de Campos, MD | FMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ortopedia e Traumatologia HC-FMUSP | Recruiting | São Paulo | São Paulo | 05410-000 | Brazil |
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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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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 1 ampoule of Hylan GF-20 | Drug | Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20 |
|
|
| 2 ampoules of Hylan GF-20 | Drug | Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20 |
|
|
| 3 ampoules of Hylan GF-20 | Drug | Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20 |
|
|
| D017670 |
| Sodium Compounds |