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

IntroductionNewly formulated trehalose-hyaluronic acid (T-HA) has proven to be more stable in vitro the effects of hyaluronidase enzyme.ObjectivesTo compare clinical outcomes T-HA with standard non–trehalose (NT-HA) hyal-uronic when administered as infiltrative therapy patients symptomatic osteoarthritis knee.MethodsA prospective controlled trial parallel arms was performed. Sixty persistent knee were randomized or non–trehalose-hyaluronic groups. Each patient received 3 doses either products separated by 15 days, a follow-up at (T1) and 6 (T2) months. The study blinded for participants, caregivers, outcome assessors. Treatment performance measured International Knee Documentation Committee (IKDC), Injury Osteoarthritis Outcome Score (KOOS), Visual Analogue Scale (VAS) pain scores compared basal between groups.ResultsEach group consisted 30 patients; mean age 56.4 ± 15.6 years. At months, IKDC, KOOS, VAS improved both groups (P < .05). continued improve .05), while NT-HA decreased IKDC increased 66.98 (60.92-78.79) T-HA, it 59.77 (35.34-73.03) NT-HA.ConclusionsBoth NT-THA are safe effective treating early symptoms. provides longer duration symptom relief than does. Further studies needed determine total lasting T-HA.