Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 유재두 | * |
dc.date.accessioned | 2017-07-04T01:07:36Z | - |
dc.date.available | 2017-07-04T01:07:36Z | - |
dc.date.issued | 2017 | * |
dc.identifier.issn | 1471-2474 | * |
dc.identifier.other | OAK-20756 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/235419 | - |
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. Trial registration: ClinicalTrials.gov (NCT01510535). This trial was registered on January 6, 2012. © 2017 The Author(s). | * |
dc.language | English | * |
dc.publisher | BioMed Central Ltd. | * |
dc.subject | Hyaluronic acid | * |
dc.subject | Inflammation | * |
dc.subject | Knee osteoarthritis | * |
dc.subject | Treatment | * |
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.relation.issue | 1 | * |
dc.relation.volume | 18 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.journaltitle | BMC Musculoskeletal Disorders | * |
dc.identifier.doi | 10.1186/s12891-017-1591-4 | * |
dc.identifier.wosid | WOS:000402333300003 | * |
dc.identifier.scopusid | 2-s2.0-85019654628 | * |
dc.author.google | Ha C.-W. | * |
dc.author.google | Park Y.-B. | * |
dc.author.google | Choi C.-H. | * |
dc.author.google | Kyung H.-S. | * |
dc.author.google | Lee J.-H. | * |
dc.author.google | Yoo J.D. | * |
dc.author.google | Yoo J.-H. | * |
dc.author.google | Kim C.-W. | * |
dc.author.google | Kim H.-C. | * |
dc.author.google | Oh K.-J. | * |
dc.author.google | Bin S.-I. | * |
dc.author.google | Lee M.C. | * |
dc.contributor.scopusid | 유재두(16641404300) | * |
dc.date.modifydate | 20240118131633 | * |