An Investigator-Initiated, Prospective, Single-Center, Open-Label Clinical Study to Evaluate Safety and Performance of Intra-Articular Hyaluronic Acid (IA-HA) (Biovisc Ortho) in Patients with Osteoarthritis (OA) of the Knee.

Objective: IA-HA is injected into the osteoarthritis knee as a viscosupplementation for therapeutic purposes. This clinical trial was carried out for evaluating the efficacy and safety of Biovisc Ortho IA-HA (20 mg/2 mL) in a 2 mL prefilled syringe.

Design: The study was conducted as an open-label, single-center, single-arm clinical trial in India. Patients of knee OA with moderate to severe symptoms for a minimum duration of 3 months were included in the study. Five visits were conducted at weekly intervals and the investigational product was administered at each visit. Two follow-up visits were conducted at 3 and 6 months after the completion of the last injection cycle. The primary outcome variable was change in KOOS pain score from baseline. The secondary outcome variables were analyzed for other KOOS scales and safety of the device.

Results: Change in KOOS pain score at 6 months from baseline was 29.71±15.74 and the change in mean KOOS score for pain was statistically significant (p<0.0001) for all post-baseline visits. Statistically significant improvement was observed for mean values of efficacy assessments (KOOS) during the study period (6 months) for all the domains evaluated, including pain, joint function and quality of life.

Conclusion: Despite being an open, noncomparative study, the safety and efficacy results of IA-HA establish the therapeutic effect of the treatment throughout the study period of 6 months and are safe.