%0 Journal Article
%A Gavín, Carlos
%A J Blanco, Francisco
%A L Pablos, José
%A Caracuel, Miguel A
%A Rosas, José
%A Gómez-Barrena, Enrique
%A Navarro, Francisco
%A Coronel, María Pilar
%A Gimeno, Mercedes
%T One-Year, Efficacy and Safety Open Label Study, with a Single Injection of a New Hyaluronan for Knee OA: The SOYA Trial.
%D 2021
%@ 1178-7090
%U https://hdl.handle.net/10668/25741
%X To assess the efficacy and safety of a single injection of a new formulation of hyaluronic acid (MPS-HA2%) in patients with symptomatic knee osteoarthritis after 12 months' follow-up. Prospective, single-arm, multicentre, open-label, 12-month follow-up study. Patients with Kellgren-Lawrence (KL) 2-3 and visual analogue scale (VAS) pain scores of ≥40- A total of 101 patients (mean age: 68 years; 74% female; and 78% overweight) were included. The mean reduction in pain at 12 months was 37.7%; the total WOMAC score improved by 36.5% and the pain, stiffness and physical function subscores returned improvements of 32.1%, 34.1% and 32.7%, respectively (p=0.0001 with respect to baseline). At 12 months, a statistically significant 62.2% of patients obtained an improvement equal to or greater than the MCII. The mean PGA score at baseline was 2.44 and 1.46 at 12 months (p With just a single intra-articular injection, this not controlled trial suggests that MPS-HA2% is effective 12 months after the procedure in most cases. Patient tolerability and safety were both optimal (NCT03852914).
%K hyaluronic acid
%K osteoarthritis
%K pain
%K viscosupplementation
%~