The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study. European patients (n = 284) were randomized 1:1 (test product:comparator) and received one injection of cross-linked hyaluronic acid (60 mg/3 mL). In total, 280 patients completed the study. The primary endpoint of mean change in Western Ontario and McMaster University (WOMAC)-Likert Pain sub-scores from baseline at week 13 revealed changes of -5.59 and -5.54 for the test and comparator groups, respectively, demonstrating non-inferiority of the test product (difference, -0.05 [95% confidence interval, -0.838 to 0.729]). Secondary endpoint results, which included changes in WOMAC-Likert Pain sub-score from baseline to 26 weeks post-injection and changes in WOMAC-Likert Total score and Physical Function and Stiffness sub-scores, changes in patients' and investigators' global assessments, use of rescue medication, and responder rates at 13 and 26 weeks post-injection were similar between the groups. Incidence of adverse events was also similar. In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis.

Clinic of Healthy Bone 90 552 Lodz Poland

Clinic of Rehabilitation and Orthopedics Medical University of Lublin 20 090 Lublin Poland

Institute of Rheumatology 12850 Prague Czech Republic

Life Sciences LG Chem Ltd Seoul 07336 Republic of Korea

Orthopedic Department Rydygier's Hospital 31 826 Krakow Poland

Rheumatic Center of Dr Mostera 61500 Brno Czech Republic

Specjalistyczny Osrodek Leczniczo Badawczy 14 100 Ostroda Poland

Trauma and Orthopedic Ward NZOZ Medi Spatz 44 100 Gliwice Poland

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