Safety and performance of trehalose hyaluronic acid versus standard infiltrative therapy based on medium weight sodium hyaluronate in knee joint osteoarthritis treatment

INTERVENTION: Participants are randomized with an allocation ratio of 1:1 to receive either T‐HA or NT‐HA. The manufacturer provided the products labelled as A or B (corresponding to group A or B, respectively). Both products had the same syringe, color (transparent), texture, and quantity (2 ml). In this way, the study was blinded for patients, clinicians, researchers, and the manufacturer who handled the product. The nature of the product was revealed only when the study was finished. Each patient received three doses separated within 15 days. CONDITION: Osteoarthritis of the knee ; Musculoskeletal Diseases ; Gonarthrosis [arthrosis of knee] PRIMARY OUTCOME: Treatment performance measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), and Visual Analogue Scale (VAS) at baseline, 3, and 6 months SECONDARY OUTCOME: Safety measured using adverse reactions recorded for the duration of the trial INCLUSION CRITERIA: 1. Aged 18 to 80 years 2. Symptomatic knee osteoarthritis, grade I to III according to Kellgren and Lawrence classification 3. Without pain relief after at least 3 months of non‐invasive treatment 4. Osteoarthritis diagnosed by x‐ray and classified according to Kellgren and Lawrence classification