Evaluation on the efifcacy and safety of Hylan G-F20 (Synvisc?) for the treatment of knee osteoarthritis in Chinese patients：a prospective, single arm, multicenter study
XUAN Liang
YANG Hui-lin
XUE Qing-yun
YAN Shi-gui
KAN Wu-sheng
WANG Chen
ZHU Zhen-an
Abstract：Objective To assess the efifcacy and safety of Hylan G-F20 ( Synvisc? ) in a study on the treatment of knee steoarthritis in Chinese patients conducted as a prospective interventional single arm clinical trial.Methods Totally 237 patients with symptomatic knee osteoarthritis were enrolled. After signing the informed consent form, patients meeting the inclusion and exclusion criteria received three intra-articular injections of 2 ml Hylan G-F20 at weekly intervals and were followed up for evaluating the changes in Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ), Patient Global Assessment ( PTGA ) score and Clinical Observer Global Assessment ( COGA ) between baseline and weeks 8, 12 and 26.Results The score of walk associated pain ( WOMAC A1 ) was changed signiifcantly over 8, 12 and 26 weeks from baseline in 232 patients injected with Hylan G-F20. Particularly the primary outcome of WOMAC A1 score at week of 26 was reduced signiifcantly by 33.0 ± 17.71 (x-±s ) (P< 0.0001 ) with reduction rate of 59%. At week 26, the scores of WOMAC A, WOMAC B and WOMAC C were respectivelyreduced by 121.5 ± 77.2, 36.6 ± 39.8 and 358.4 ± 270.5 (P < 0.0001 ). The pattern of PIGA and COGA assessments signiifcantly changed at 8, 12 and 26 weeks, which indicate the greater improvement of knee osteoarthritis of subjects along with the proceeding of the trial. In the study, adverse effects were reported in 66 patients ( 27.8% ), including 9 of whom ( 3.8% ) were related to the treatment. Neither serious adverse effect due to the treatment nor death were reported. Conclusions This study demonstrated that in patients with knee osteoarthritis, an intra-articular injection of Hylan G-F20 is safe and effective in providing statistically signiifcant, clinically relevant pain relief over 26 weeks. <br> reduced by 121.5 ± 77.2, 36.6 ± 39.8 and 358.4 ± 270.5 (P < 0.0001 ). The pattern of PIGA and COGA assessments signiifcantly changed at 8, 12 and 26 weeks, which indicate the greater improvement of knee osteoarthritis of subjects along with the proceeding of the trial. In the study, adverse effects were reported in 66 patients ( 27.8% ), including 9 of whom ( 3.8% ) were related to the treatment. Neither serious adverse effect due to the treatment nor death were reported. Conclusions This study demonstrated that in patients with knee osteoarthritis, an intra-articular injection of Hylan G-F20 is safe and effective in providing statistically signiifcant, clinically relevant pain relief over 26 weeks.
Keywords：OsteoarthritisHyaluronic acidViscosupplementationKnee jointHylan G-F20
Publication Date：2016-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：7( 310-316 )