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

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) hyal- uronic 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 per- sistent 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 (T1 ) and 6 (T2 ) months. The study was blinded for participants, caregivers, and outcome assessors. Treatment performance was measured with the International Knee Docu- mentation 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. Results: Each group consisted of 30 patients; the mean age was 56.4 ± 15.6 years. At 3 months, IKDC, KOOS, and VAS improved for both groups (P < .05). At 6 months, group T-HA continued to improve IKDC, KOOS, and VAS (P < .05), while group NT-HA scores decreased (P < .05). IKDC increased to 66.98 (60.92-78.79) for T-HA, while it decreased to 59.77 (35.34-73.03) for NT-HA. Conclusions: Both T-HA and NT-THA are safe and effective for treating early osteoarthritis symp- toms. T-HA provides a longer duration of symptom relief than NT-HA does. Further studies are needed to determine the total lasting effects of T-HA.