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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
DC Field | Value | Language |
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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 | 2017-06-07T00:36:14Z | - |
dc.date.available | 2017-06-07T09:45:38Z | - |
dc.date.issued | 2017-05-26 | - |
dc.identifier.citation | BMC Musculoskeletal Disorders, 18(1):223 | ko_KR |
dc.identifier.uri | 10.1186/s12891-017-1591-4 | - |
dc.identifier.uri | https://hdl.handle.net/10371/117655 | - |
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 12weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patients and investigators global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. Results Mean changes of WBP at 12weeks after the last injection were −33.3mm with XLHA and −29.2mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (−1.9mm, 10.1mm) was well above the predefined margin (−10mm). 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. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BioMed Central | ko_KR |
dc.subject | Knee osteoarthritis | ko_KR |
dc.subject | Inflammation | ko_KR |
dc.subject | Treatment | ko_KR |
dc.subject | Hyaluronic acid | ko_KR |
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 | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 하철원 | - |
dc.contributor.AlternativeAuthor | 박용범 | - |
dc.contributor.AlternativeAuthor | 최종혁 | - |
dc.contributor.AlternativeAuthor | 경희수 | - |
dc.contributor.AlternativeAuthor | 이주홍 | - |
dc.contributor.AlternativeAuthor | 유재두 | - |
dc.contributor.AlternativeAuthor | 유지형 | - |
dc.contributor.AlternativeAuthor | 최중혁 | - |
dc.contributor.AlternativeAuthor | 김창완 | - |
dc.contributor.AlternativeAuthor | 김희천 | - |
dc.contributor.AlternativeAuthor | 오광준 | - |
dc.contributor.AlternativeAuthor | 빈성일 | - |
dc.contributor.AlternativeAuthor | 이명철 | - |
dc.language.rfc3066 | en | - |
dc.rights.holder | The Author(s). | - |
dc.date.updated | 2017-05-28T03:27:58Z | - |
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