A Six-Month Study on the Efficacy and Safety of a Single Intra-Articular Injection of Sodium Hyaluronate in Knee Osteoarthritis

Objective: This single-center, open-label, phase IV study aimed to evaluate the six-month efficacy and safety of a single intra-articular injection of 2% sodium hyaluronate (Hyarelief®) in patients with grade III knee osteoarthritis (OA). Material and Methods: Ninety patients aged ≥40 years with ACR-defined grade III knee OA received a single injection. Primary outcomes were pain intensity (10-cm Visual Analogue Scale, VAS) and joint function (WOMAC index), assessed at baseline and on days 15, 30, 60, 90, 120, 150, and 180. A linear mixed model with Bonferroni correction analyzed changes over time. Subgroup analyses (Mann-Whitney U test) examined differences by gender, adverse events, and rescue medication use. Results: A significant effect of time was found for both VAS (F=263.319, p