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Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: A double-blind, randomized, multi-center, non-inferiority study

Title
Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: A double-blind, randomized, multi-center, non-inferiority study
Authors
Ha C.-W.Park Y.-B.Choi C.-H.Kyung H.-S.Lee J.-H.Yoo J.D.Yoo J.-H.Kim C.-W.Kim H.-C.Oh K.-J.Bin S.-I.Lee M.C.
Ewha Authors
유재두
SCOPUS Author ID
유재두scopus
Issue Date
2017
Journal Title
BMC Musculoskeletal Disorders
ISSN
1471-2474JCR Link
Citation
vol. 18, no. 1
Keywords
Hyaluronic acidInflammationKnee osteoarthritisTreatment
Publisher
BioMed Central Ltd.
Indexed
SCIE; SCOPUS WOS scopus
Abstract
Background: This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. Methods: Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness. Primary endpoint was the change of weight-bearing pain (WBP) at 12 weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patient's and investigator's global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20 mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. Results: Mean changes of WBP at 12 weeks after the last injection were -33.3 mm with XLHA and -29.2 mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). There were no significant between-group differences in all secondary endpoints. Injection site pain was the most common adverse event and no remarkable safety issue was identified. Conclusions: This study demonstrated that a single injection of XLHA was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe treatment for knee osteoarthritis. Trial registration: ClinicalTrials.gov (NCT01510535). This trial was registered on January 6, 2012. © 2017 The Author(s).
DOI
10.1186/s12891-017-1591-4
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의학전문대학원 > 의학과 > Journal papers
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