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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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The purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.
So far there is no convincing evidence that any treatment can be really effective in slowing or preventing the development of OA. The viscosupplementation by intraarticular injection of hyaluronate-derived products has gained popularity as a treatment modality of gonarthrosis. Today there are various papers on the treatment of gonarthrosis by intraarticular injection. Several methods have shown good results. There isn't, however, a consensus on the best method. The investigators know that in the treatment of osteoarthritis, with the viscosupplementation Hylan is superior in the long term, than the infiltration with cortisone. The good short term results achieved by infiltration of cortisone make us think about the combination of these drugs. The investigators will be assessing 104 patients with osteoarthritis of the knee, divided into two groups. Patients in group 1 will be subjected to infiltration procedure 6ml of Hylan. Patients in Group 2 will undergo the procedure of infiltration with 6ml of Hylan and 1ml (20mg) of hexacetonide Triamcinolone. The researcher will apply the informed consent term, the pain visual analog scale (VAS), WOMAC and Lequesne questionnaires. The questionnaires will be answered before infiltration (week zero), one week after the puncture (week 1), four weeks after (week 4) and 12 weeks after (week 12) and 24 weeks after (week 24).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hylan GF-20 alone | Active Comparator | This arm will receive a knee infiltration with 6ml of Hylan GF-20 only |
|
| Triamcinolone | Experimental | This arm will receive a knee infiltration with 6ml of Hylan GF-20 associated with 1ml of triamcinolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylan GF-20 alone | Drug | A intraarticular injection of 6ml of Hylan GF-20 (Synvisc) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Results in WOMAC, Lequesne and VAS scores | The outcome will be measured with the WOMAC and LEQUESNE scores, both about quality of life and knee function. The subjects will also use the VAS (VISUAL ANALOGIC SCALE) of pain. The results will be compared between the two groups within 1 week and 4 weeks after the viscosupplementation. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Results in WOMAC, Lequesne and VAS scores after 24 weeks | The investigators are also going to compare the results after 24 weeks | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olavo Pires de Camargo, Prof. Dr. | Faculdade de Medicina da Universidade de São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ortopedia e Traumatologia do Hospital das ClÃnicas da Universidade de São Paulo | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15703953 | Background | Ozturk C, Atamaz F, Hepguler S, Argin M, Arkun R. The safety and efficacy of intraarticular hyaluronan with/without corticosteroid in knee osteoarthritis: 1-year, single-blind, randomized study. Rheumatol Int. 2006 Feb;26(4):314-9. doi: 10.1007/s00296-005-0584-z. Epub 2005 Feb 10. | |
| 20048527 | Background | Brander VA, Stadler TS. Functional improvement with hylan G-F 20 in patients with knee osteoarthritis. Phys Sportsmed. 2009 Oct;37(3):38-48. doi: 10.3810/psm.2009.10.1728. |
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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 |
|---|---|
| C049816 | hylan |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Triamcinolone | Drug | A Intraarticular injection of 6ml of Hylan GF-20 (Synvisc) + 1ml of triamcinolone (Triancil) |
|
|
| 18430574 | Background | Raman R, Dutta A, Day N, Sharma HK, Shaw CJ, Johnson GV. Efficacy of Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee -- a prospective randomized clinical trial. Knee. 2008 Aug;15(4):318-24. doi: 10.1016/j.knee.2008.02.012. Epub 2008 Apr 21. |
| 10768539 | Background | Goorman SD, Watanabe TK, Miller EH, Perry C. Functional outcome in knee osteoarthritis after treatment with hylan G-F 20: a prospective study. Arch Phys Med Rehabil. 2000 Apr;81(4):479-83. doi: 10.1053/mr.2000.4432. |
| 16083536 | Background | Kemper F, Gebhardt U, Meng T, Murray C. Tolerability and short-term effectiveness of hylan G-F 20 in 4253 patients with osteoarthritis of the knee in clinical practice. Curr Med Res Opin. 2005 Aug;21(8):1261-9. doi: 10.1185/030079905X56501. |
| 19950318 | Background | Bannuru RR, Natov NS, Obadan IE, Price LL, Schmid CH, McAlindon TE. Therapeutic trajectory of hyaluronic acid versus corticosteroids in the treatment of knee osteoarthritis: a systematic review and meta-analysis. Arthritis Rheum. 2009 Dec 15;61(12):1704-11. doi: 10.1002/art.24925. |
| 16625635 | Background | Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005321. doi: 10.1002/14651858.CD005321.pub2. |
| 19304567 | Background | Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. doi: 10.1136/ard.2008.094623. |
| 18365224 | Background | Conrozier T, Jerosch J, Beks P, Kemper F, Euller-Ziegler L, Bailleul F, Chevalier X. Prospective, multi-centre, randomised evaluation of the safety and efficacy of five dosing regimens of viscosupplementation with hylan G-F 20 in patients with symptomatic tibio-femoral osteoarthritis: a pilot study. Arch Orthop Trauma Surg. 2009 Mar;129(3):417-23. doi: 10.1007/s00402-008-0601-2. Epub 2008 Mar 26. |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |