Double-blinded prospective randomized clinical trial in knee joint osteoarthritis treatment: safety assessment and performance of trehalose hyaluronic acid versus standard infiltrative therapy based on medium-weight sodium hyaluronate
Alberto Gobbi, Macarena Morales, Giulia Avio, Riccardo D’Ambrosi
Abstract
Introduction: Newly formulated trehalose-hyaluronic acid (T-HA) has proven to be more stable in vitro to the effects of hyaluronidase enzyme. Objectives: To compare clinical outcomes of T-HA with standard non-trehalose (NT-HA) hyaluronic acid when administered as infiltrative therapy in patients with symptomatic osteoarthritis of the knee. Methods: A prospective controlled trial with parallel arms was performed. Sixty patients with persistent symptomatic knee osteoarthritis were randomized to T-HA or non-trehalose-hyaluronic acid groups. Each patient received 3 doses of either of the products separated by 15 days, with a follow-up at 3 (T 1 ) and 6 (T 2 ) months. The study was blinded for participants, caregivers, and outcome assessors. Treatment performance was measured with the International Knee Documentation Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Visual Analogue Scale (VAS) for pain outcome scores and was compared with basal scores and between groups.