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A single 3 mL injection of either HYAJOINT Plus or Durolane can be considered safe and substantially effective for knee osteoarthritis for 52 weeks.
While a single HYAJOINT Plus (HJP) or Durolane injection was efficient and safe for a minimum of 52 weeks, HJP offered better improvement in terms of satisfaction score, visual analog scale (VAS) pain and stiffness scores, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores for 39 weeks after treatment in knee osteoarthritis patients.
The 52-week efficacy and safety of HJP and Durolane for knee osteoarthritis management were compared by researchers in a double-blind randomized controlled trial. HJP or Durolane was injected into participants at a single dose of 3 mL. At 26 weeks after the injection, a VAS pain assessment served as the major endpoint. Other clinical, satisfaction and safety evaluations over 52 weeks were the secondary endpoints ascertained.
Overall, 142 subjects were randomized evenly. HJP elicited better VAS pain alleviation than Durolane for 26 weeks post-injection. In comparison to the Durolane group, the patients in the HJP group exhibited reduced VAS pain at week 26 (24.4 ± 14.0 vs 18.1 ± 9.5), as shown in Figure 1:
Following injection, 52 weeks later, both groups experienced improvements in their stiffness levels, VAS pain, total scores, and WOMAC pain. For 39 weeks, the HJP group displayed improved stiffness scores and VAS pain, decreased WOMAC pain and stiffness scores, reduced Timed "Up & Go" (TUG) time, and greater satisfaction scores when compared to the Durolane group. There were only self-limited, mild adverse events (40.8%). To conclude, both HJP and Durolane are effective and safe for at least 52 weeks in people suffering from osteoarthritis of the knee.
Pharmaceutics
Single Injection of Cross-Linked Hyaluronate in Knee Osteoarthritis: A 52-Week Double-Blind Randomized Controlled Trial
Po-Yen Ko et al.
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