Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023728%3A_____%2F23%3AN0000032" target="_blank" >RIV/00023728:_____/23:N0000032 - isvavai.cz</a>

Result on the web

<a href="https://doi.org/10.3390/jcm12082982" target="_blank" >https://doi.org/10.3390/jcm12082982</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/jcm12082982" target="_blank" >10.3390/jcm12082982</a>

Result language

angličtina

Original language name

Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study

Original language description

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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30218 - General and internal medicine

Project

—

Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2023

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of Clinical Medicine

ISSN

2077-0383

e-ISSN

2077-0383

Volume of the periodical

2023

Issue of the periodical within the volume

Art. Nr. 2982

Country of publishing house

CH - SWITZERLAND

Number of pages

13

Pages from-to

1-13

UT code for WoS article

000977332000001

EID of the result in the Scopus database

2-s2.0-85154552416