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 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.
Raman
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R
Department of Trauma and Orthopaedics, Hull Royal Infirmary, Hull, HU2 3JZ, United Kingdom. raghu1177@yahoo.com
Dutta
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A
Day
N
N
Sharma
H K
HK
Shaw
C J
CJ
Johnson
G V
GV
D001672:Biocompatible Materials / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D017060:Patient Satisfaction; D011446:Prospective Studies; D016059:Range of Motion, Articular; D020127:Recovery of Function; D016896:Treatment Outcome; D055676:Viscosupplementation
D001672:Biocompatible Materials; C049816:hylan; D006820:Hyaluronic Acid