Publication of a clinical trial evaluating Ostenil Plus in osteoarthritis

Geneva, January 15, 2020

TRB announces the publication of the results of a French multicenter, randomized, double-blind, controlled, non-inferiority study involving 292 patients with knee osteoarthritis, whose aim was to compare a single injection of Ostenil Plus (non-chemically modified 2% sodium hyaluronate) with a single injection of 0.8% hylan G‑F 20 (Synvisc‑One). “This study is the first face-to-face double-blind randomized controlled trial comparing the efficacy and safety of two single-shot hyaluronic acid preparations” said Dr. Emmanuel Maheu, first author of the publication, rheumatologist at Hôpital Saint-Antoine, AP-HP, Paris, France and in private practice.

Published in PLOS ONE, the results demonstrate that Ostenil Plus was non-inferior to hylan G‑F 20 in reducing pain measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale six months after the injection, thus meeting the primary endpoint of the study. At this time point, Ostenil Plus led to a pain reduction of almost 60% versus baseline that was equivalent to hylan G‑F 20 treatment.

The analysis of secondary outcomes (including changes in joint stiffness, physical function, patient’s assessment of treatment efficacy, and rate of responders) did not show any statistically significant difference between Ostenil Plus and hylan G‑F 20 at any of the evaluated time points. From a safety point of view, both treatments were well tolerated. Adverse events were principally local and resolved spontaneously in most of the cases. Although the difference was not statistically significant, a higher proportion of hylan G‑F 20 patients (34.9%) than of Ostenil Plus patients (27.5%) reported treatment-emergent adverse events. In particular, injection site reactions and injection site joint pain were numerically higher in the hylan G‑F 20 group.

One injection of Ostenil Plus (2% linear sodium hyaluronate) met the non-inferiority primary endpoint versus 0.8% hylan G‑F 20, which was the reduction in pain at 6 months post injection
No difference was observed between Ostenil Plus and hylan G‑F 20 for any of the secondary endpoints
Results of this multicenter, randomized, controlled trial were recently published in PLOS ONE journal