Abstract
IntroductionNewly formulated trehalose-hyaluronic acid (T-HA) has proven to be more stable in vitro to the effects of hyaluronidase enzyme. ObjectivesTo 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. MethodsA 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 (T1) and 6 (T2) 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. ResultsEach 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. ConclusionsBoth T-HA and NT-THA are safe and effective for treating early osteoarthritis symptoms. 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.
Highlights
Hyaluronic acid is an effective treatment for early symptomatic knee osteoarthritis (OA)
International Knee Documentation Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Visual Analogue Scale (VAS) improved for both groups (P
Regarding NT-HA, IKDC, KOOS, and VAS improved clinically at three months compared to the basal score
Summary
Hyaluronic acid is an effective treatment for early symptomatic knee osteoarthritis (OA) It decreases symptoms by lubrication and shock absorption. A non-reducing disaccharide, has long been used in the biopharmaceutical industry to stabilize proteins; it is formed by two glucose molecules linked by an α, α1,1 bond These bonds confer resistance on trehalose to acid hydrolysis, stabilizing the substance at high temperatures and in acidic environments (pH 2 and 100°c for 24h) providing high resistance to oxidation and early degradation[3]. As trehalose hyaluronic acid (T-HA) has improved resistance to hyaluronidase in vitro compared to non-trehalose (NT-HA), we hypothesize that in-vivo T-HA has longerlasting clinical results than NT-HA has when applied as an injectable formula for OA symptomatic knees
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