Clinical Efficacy
Reproducible Outcomes
The SYNVISC® family of viscosupplements delivers reproducible results in significant pain reduction for up to 6 months, as demonstrated in multiple, randomized, controlled studies1-4
Findings from clinical practice indicate that more of the patients with early and intermediate-stage knee OA had better response to hylan treatment than patients with end-stage knee OA5
Synvisc-One® Clinical Efficacy
In a saline-controlled trial, Synvisc-One delivered superior pain relief over 26 weeks.2
More than 70% of patients responded to Synvisc-One2
Walking pain response rates
Greater magnitude of pain relief with Synvisc-One vs. saline control1
Study Design
- Prospective, randomized, double-blind multicenter trial of 253 patients who had osteoarthritis of the knee confirmed via recent radiograph and were at least 40 years old.
- The primary end point was the difference between the groups in the change from baseline in patient-assessed pain as measured by the WOMAC A score (average of 5 questions) over 26 weeks.
- Patients were followed for 26 weeks. Study visits were scheduled for screening, baseline, and weeks 1, 4, 8, 12, 18, and 26.
- If a patient had at least mild pain in the injected knee at the week 26 visit, he or she was offered an injection of Synvisc-One and were followed for 4 weeks for repeat treatment safety.
Efficacy Results2
- The primary end point for the study, the difference between the treatment groups in change from baseline over 26 weeks in the WOMAC A Pain Score, was met.
- Synvisc-One also demonstrated superiority to saline control in multiple predefined secondary outcome measures, which included Patient Global Assessment over and at 26 weeks, Clinical Observer Global Assessment over and at 26 weeks, and pain while walking on a flat surface (WOMAC A1) over and at 26 weeks.
References
- Wobig M, Dickhut A, Maier R, Vetter G. Viscosupplementation with hylan G-F 20: a 26-week controlled trial of efficacy and safety in the osteoarthritic knee. Clin Ther. 1998;20(3):410-423
- Chevalier X, Jerosch J, Goupille P, et al. 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;69(1):113-119.
- 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;15(4):318-324.
- Caborn D, Rush J, Lanzer W, Parenti D, Murray C; Synvisc 901 Study Group. A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. J Rheumatol. 2004;31(2):333-343.
- Lussier A, Cividino AA, McFarlane CA, Olszynski WP, Potashner WJ, De Médicis R. Viscosupplementation with hylan for the treatment of osteoarthritis: findings from clinical practice in Canada. J Rheumatol. 1996;23(9):1579-1585
