Efficacy of Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee - A prospective randomized clinical trial

In this independent prospective randomized trial, we compared the clinical effectiveness, functional outcome and patient satisfaction following intra articular injection with two viscosupplementation agents - Hylan G-F-20 (n = 199) and Sodium Hyaluronate (n = 193) in patients with osteoarthritis (OA) of the knee. All patients were prospectively reviewed by blinded independent assessors at pre injection, 6 weeks, 3, 6, 12 months. Knee pain and patient satisfaction were measured on a visual analogue scale. Functional outcome was assessed using WONMC, Oxford knee score and EuroQol EQ-51) scores. Knee pain on VAS improved from 6.7 to 3.2 by 6 weeks (p = 0.02) and was sustained until 12 months (3.7,p = 0.04) with Hylan G-F 20. In the Sodium Hyaluronate group, pain improved from 6.6 to 5.7 at 6 weeks (p > 0.05) and to 4.1 at 3 months (p = 0.04) but was sustained only until 6 months (5.9, p > 0.05). Improvement in the WOMAC pain subscale was significantly superior in the Hylan G-F 20 group at 3 months (p = 0.02), 6 months (p = 0.0 1) and 12 months (p = 0.007). There was no significant difference in the EQ-51) scores at 6 weeks and 3 months between the two groups. The numbers of treatment related adverse events were higher (39 vs. 30) in the Hylan G-F 20 group. One patient in the Hylan G-F 20 group who had a serious adverse event was also included in the final analysis. Although both treatments offered significant pain reduction, it was achieved earlier and sustained for a longer period with Hylan G-F 20. From this study, it appeared that the clinical effectiveness and general patient satisfaction are better amongst patients who received Hylan G-F 20. (c) 2008 Elsevier B.V All rights reserved.