May 2022

Knee OA Study Reports Safety Assessment of Trehalose Hyaluronic Acid*

Figure. A) VAS score boxplot. B) IKDC score boxplot. C) KOOS symptoms boxplot.

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 (OA) of the knee.

Methods: A prospective controlled trial with parallel arms was performed. Sixty patients with persistent symptomatic knee OA 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.

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 (see figure).

Conclusions: Both T-HA and NT-THA are safe and effective for treating early OA 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.

Source: Gobbi A, Morales M, Avio G, D’Ambrosi R. 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. J Cartilage Joint Preserv. 2022; https://doi.org/10.1016/j.jcjp.2022.100043.

*See “Patient Guidance: Lifestyle and Integrative Medicine Strategies for Managing Knee Osteoarthritis,” on page 49 for strategies to share with patients.

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