Effectiveness and safety of the hyaluronic acid INNORYOS 2.2% in patients with early to advanced knee osteoarthritis. A prospective non-interventional randomized clinical trial.

Abstract

Introduction: We determined the effectiveness and safety of INNORYOS 2.2% hyaluronic acid (HA) containing 15mg of niacinamide on knee pain, stiffness and function in people with knee OA compared with an established agent. Further study objectives were to monitor side effects during the study period. Methods: The 26-week prospective non-interventional open clinical trial tested on non-inferiority of INNORYOS 2.2% compared to an established HA product (Synvisc 0.8%, 2.0 ml). Briefly, 90 people with knee OA (Kellgren-Lawrence grade I to III), 40–85 years old, were allocated randomly to the two groups. HA injections were carried out at baseline and after 1 and 2 weeks. ANCOVA that adjusted for baseline differences was applied to determine between group differences (i.e. “effects”) after 26 weeks. Results: None of the 90 participants (65.0 ± 10.5 years, BMI: 30.2 ± 5.5 kg/m²) quit the study or was lost to follow-up. In summary WOMAC pain score (p = .26) and function score (p = .49) did not differ significantly between the groups, but data significant better effect after INNORYOS 2.2% were observed for WOMAC stiffness subscale (p = .009). In detail, changes from baseline to 26-week FU average 43.6% (29.1%) for “pain”, 25.9% (0%) for “stiffness” and 37% (27.6%) for “function” subscale in the INNORYOS (Synvisc) group. No adverse effects were observed or reported by the participants. As determined by personal interviews and recorded in the questionnaires no changes of co-medication with impact on the study outcomes were observed. Conclusion: We did not determine significantly lower effects compared with the established product. In contrast, INNORYOS 2.2% tendentially revealed more favourable effect on all WOMAC categories (significant for “stiffness”). Thus, the present study provided further evidence for the effectiveness and safety of INNORYOS 2.2% in patients with early to advanced knee osteoarthritis.