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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
- 유재두
- Issue Date
- 2017
- Journal Title
- BMC Musculoskeletal Disorders
- ISSN
- 1471-2474
- Citation
- BMC Musculoskeletal Disorders vol. 18, no. 1
- Keywords
- Hyaluronic acid; Inflammation; Knee osteoarthritis; Treatment
- Publisher
- BioMed Central Ltd.
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- 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
- Appears in Collections:
- 의과대학 > 의학과 > Journal papers
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