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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

 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 
Journal Title
Issue Date
Adjuvants, Immunologic/administration & dosage* ; Adjuvants, Immunologic/chemistry ; Aged ; Cross-Linking Reagents/administration & dosage* ; Cross-Linking Reagents/chemistry ; Double-Blind Method ; Female ; Humans ; Hyaluronic Acid/administration & dosage* ; Hyaluronic Acid/chemistry ; Male ; Middle Aged ; Osteoarthritis, Knee/diagnosis* ; Osteoarthritis, Knee/drug therapy* ; Prospective Studies ; Treatment Outcome
Hyaluronic acid ; Inflammation ; Knee osteoarthritis ; Treatment
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.
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Chong Hyuk(최종혁) ORCID logo https://orcid.org/0000-0002-9080-4904
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