S-Space College of Medicine/School of Medicine (의과대학/대학원) Orthopedic Surgery (정형외과학전공) Journal Papers (저널논문_정형외과학전공)
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
Cited 0 time in Web of Science Cited 0 time in Scopus
- Issue Date
- BioMed Central
- BMC Musculoskeletal Disorders, 18(1):223
- Knee osteoarthritis ; Inflammation ; Treatment ; Hyaluronic acid
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.
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.
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.
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.
- Files in This Item:
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.