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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

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dc.contributor.author최종혁-
dc.date.accessioned2018-07-20T11:54:22Z-
dc.date.available2018-07-20T11:54:22Z-
dc.date.issued2017-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161477-
dc.description.abstractBACKGROUND: 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.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherBioMed Central-
dc.relation.isPartOfBMC MUSCULOSKELETAL DISORDERS-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdjuvants, Immunologic/administration & dosage*-
dc.subject.MESHAdjuvants, Immunologic/chemistry-
dc.subject.MESHAged-
dc.subject.MESHCross-Linking Reagents/administration & dosage*-
dc.subject.MESHCross-Linking Reagents/chemistry-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHHyaluronic Acid/administration & dosage*-
dc.subject.MESHHyaluronic Acid/chemistry-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHOsteoarthritis, Knee/diagnosis*-
dc.subject.MESHOsteoarthritis, Knee/drug therapy*-
dc.subject.MESHProspective Studies-
dc.subject.MESHTreatment Outcome-
dc.titleEfficacy 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.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Orthopedic Surgery-
dc.contributor.googleauthorChul-Won Ha-
dc.contributor.googleauthorYong-Beom Park-
dc.contributor.googleauthorChong-Hyuk Choi-
dc.contributor.googleauthorHee-Soo Kyung-
dc.contributor.googleauthorJu-Hong Lee-
dc.contributor.googleauthorJae Doo Yoo-
dc.contributor.googleauthorJu-Hyung Yoo-
dc.contributor.googleauthorChoong-Hyeok Choi-
dc.contributor.googleauthorChang-Wan Kim-
dc.contributor.googleauthorHee-Chun Kim-
dc.contributor.googleauthorKwang-Jun Oh-
dc.contributor.googleauthorSeong-Il Bin-
dc.contributor.googleauthorMyung Chul Lee-
dc.identifier.doi10.1186/s12891-017-1591-4-
dc.contributor.localIdA04187-
dc.relation.journalcodeJ00366-
dc.identifier.eissn1471-2474-
dc.identifier.pmid28549436-
dc.subject.keywordHyaluronic acid-
dc.subject.keywordInflammation-
dc.subject.keywordKnee osteoarthritis-
dc.subject.keywordTreatment-
dc.contributor.alternativeNameChoi, Chong Hyuk-
dc.contributor.affiliatedAuthorChoi, Chong Hyuk-
dc.citation.volume18-
dc.citation.number1-
dc.citation.startPage223-
dc.identifier.bibliographicCitationBMC MUSCULOSKELETAL DISORDERS, Vol.18(1) : 223, 2017-
dc.identifier.rimsid61384-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers

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