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 WOMAC, Oxford knee score and EuroQol EQ-5D 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=0.01) and 12 months (p=0.007). There was no significant difference in the EQ-5D 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.