Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for ... View Full Text


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Article Info

DATE

2017-05-26

AUTHORS

Chul-Won Ha, Yong-Beom Park, Chong-Hyuk Choi, Hee-Soo Kyung, Ju-Hong Lee, Jae Doo Yoo, Ju-Hyung Yoo, Choong-Hyeok Choi, Chang-Wan Kim, Hee-Chun Kim, Kwang-Jun Oh, Seong-Il Bin, Myung Chul Lee

ABSTRACT

BackgroundThis 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.MethodsTwo 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.ResultsMean 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.ConclusionsThis 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 registrationClinicalTrials.gov (NCT01510535). This trial was registered on January 6, 2012. More... »

PAGES

223

References to SciGraph publications

Journal

TITLE

BMC Musculoskeletal Disorders

ISSUE

1

VOLUME

18

Author Affiliations

  • Department of Orthopedic Surgery, Stem Cell and Regenerative Medicine Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, South Korea
  • Department of Orthopedic Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 102, Heukseok-ro, Dongjak-gu, Seoul, South Korea
  • Department of Orthopedic Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, 211, Eonju-ro, Gangnam-gu, Seoul, South Korea
  • Department of Orthopedic Surgery, School of Medicine, Kyungpook National University, 130, Dongdeok-ro, Jung-gu, Daegu, South Korea
  • Department of Orthopedic Surgery, Chonbuk National University Hospital, Research Institute of Clinical Medicine, Chonbuk National University Medical School, 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do, South Korea
  • Department of Orthopedic Surgery, Ewha Womans University Mockdong Hospital, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, South Korea
  • Department of Orthopedic Surgery, National Health Insurance Corporation Ilsan Hospital, 100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
  • Department of Orthopedic Surgery, Hanyang University College of Medicine, 222-1, Wangsimni-ro, Seongdong-gu, Seoul, South Korea
  • Department of Orthopedic Surgery, Busan Paik Hospital, College of Medicine, Inje University, 75, Bokji-ro, Busanjin-gu, Busan, South Korea
  • Department of Orthopedic Surgery Bundang CHA Hospital, College of Medicine, CHA University, 59, Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea
  • Department of Orthopedic Surgery, KonKuk University Medical Center, KonKuk University School of Medicine, 120-1, Neungdong-ro, Gwangjin-gu, Seoul, South Korea
  • Department of Orthopedic Surgery, University of Ulsan, College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
  • Department of Orthopaedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, 110-744, Jongnogu, Seoul, Republic of Korea
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s12891-017-1591-4

    DOI

    http://dx.doi.org/10.1186/s12891-017-1591-4

    DIMENSIONS

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    https://www.ncbi.nlm.nih.gov/pubmed/28549436


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    20 schema:description BackgroundThis 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.MethodsTwo 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.ResultsMean 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.ConclusionsThis 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 registrationClinicalTrials.gov (NCT01510535). This trial was registered on January 6, 2012.
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    40 changes
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    42 common adverse events
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