drugset / Trial / NCT01335321
Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation
Phase 4
Completed
108 enrolled
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.
Timeline
- Start
- 2011-03
- Primary completion
- 2011-11
- Completion
- 2012-07
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Triamcinolone | Other / unclassified | 20 mg | Other |
| Comparator | Hylan G-F 20 | Other / unclassified | 6 ml | Other |