One-Year, Efficacy and Safety Open Label Study, with a Single Injection of a New Hyaluronan for Knee OA: The SOYA Trial.

ABSTRACT:

Purpose

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.

Patients and methods

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-< 80 mm received a single injection of MPS-HA2%. The primary outcome was the reduction in VAS pain scores from baseline, and the secondary outcomes were the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index, the minimum clinically important improvement (MCII), and patient and investigator global assessments (PGA, IGA) measured on 5-point Likert scale. Adverse events were recorded

SUBMITTER: Gavin C 

PROVIDER: S-EPMC8312328 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature