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

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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.

Original languageEnglish
Article number223
JournalBMC Musculoskeletal Disorders
Volume18
Issue number1
DOIs
StatePublished - 26 May 2017

Keywords

  • Hyaluronic acid
  • Inflammation
  • Knee osteoarthritis
  • Treatment

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