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
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Ha, Chul-Won | - |
dc.contributor.author | Park, Yong-Beom | - |
dc.contributor.author | Choi, Chong-Hyuk | - |
dc.contributor.author | Kyung, Hee-Soo | - |
dc.contributor.author | Lee, Ju-Hong | - |
dc.contributor.author | Yoo, Jae Doo | - |
dc.contributor.author | Yoo, Ju-Hyung | - |
dc.contributor.author | Choi, Choong-Hyeok | - |
dc.contributor.author | Kim, Chang-Wan | - |
dc.contributor.author | Kim, Hee-Chun | - |
dc.contributor.author | Oh, Kwang-Jun | - |
dc.contributor.author | Bin, Seong-Il | - |
dc.contributor.author | Lee, Myung Chul | - |
dc.date.accessioned | 2022-07-14T06:54:46Z | - |
dc.date.available | 2022-07-14T06:54:46Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2017-05 | - |
dc.identifier.issn | 1471-2474 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/152467 | - |
dc.description.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. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | BMC | - |
dc.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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Choi, Choong-Hyeok | - |
dc.identifier.doi | 10.1186/s12891-017-1591-4 | - |
dc.identifier.scopusid | 2-s2.0-85019654628 | - |
dc.identifier.wosid | 000402333300003 | - |
dc.identifier.bibliographicCitation | BMC MUSCULOSKELETAL DISORDERS, v.18, pp.1 - 10 | - |
dc.relation.isPartOf | BMC MUSCULOSKELETAL DISORDERS | - |
dc.citation.title | BMC MUSCULOSKELETAL DISORDERS | - |
dc.citation.volume | 18 | - |
dc.citation.startPage | 1 | - |
dc.citation.endPage | 10 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Orthopedics | - |
dc.relation.journalResearchArea | Rheumatology | - |
dc.relation.journalWebOfScienceCategory | Orthopedics | - |
dc.relation.journalWebOfScienceCategory | Rheumatology | - |
dc.subject.keywordPlus | ACID | - |
dc.subject.keywordPlus | VISCOSUPPLEMENTATION | - |
dc.subject.keywordPlus | RECOMMENDATIONS | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.subject.keywordPlus | CRITERIA | - |
dc.subject.keywordPlus | HIP | - |
dc.subject.keywordAuthor | Knee osteoarthritis | - |
dc.subject.keywordAuthor | Inflammation | - |
dc.subject.keywordAuthor | Treatment | - |
dc.subject.keywordAuthor | Hyaluronic acid | - |
dc.identifier.url | https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-017-1591-4 | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Korea+82-2-2220-1365
COPYRIGHT © 2021 HANYANG UNIVERSITY.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.