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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2017

Open Access 01-12-2017 | Research article

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

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

Published in: BMC Musculoskeletal Disorders | Issue 1/2017

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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.
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Metadata
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
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
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2017
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-017-1591-4

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