Safety and Effectiveness of a Novel Liposomal Intra-Articular Lubricant in Symptomatic Knee Osteoarthritis: A First-in-Human Study.

Abstract

Background/Objectives: Osteoarthritis (OA) is a common disease that affects almost half the population at some point in their lives, causing pain and decreased functional capacity. New conservative treatment modalities are being proposed to provide symptomatic relief and delay surgical intervention. This study aimed at evaluating the safety of the novel liposomal boundary lubricant, injected intra-articularly in patients with moderate knee OA. Additionally, the effect on the functionality and life quality was assessed. Methods: Eighteen of the twenty screened subjects met inclusion criteria and were enrolled in the study. After receiving a single IA injection of AqueousJoint, patients were prospectively evaluated at baseline and at 2, 4, 8, 12, and 26 weeks. Numeric Pain Rating Scale (NRS), Knee injury and Osteoarthritis Outcome Score (KOOS), Short Form Health Survey (SF12) and range of motion were also recorded. Results: The final analysis was conducted on 18 subjects. No adverse events related to the investigational product were observed in the study. No serious adverse events were observed at all. A significant decrease in pain was demonstrated at all time points vs. baseline (Friedman X² = 35.08, p < 0.001). Significant improvement was demonstrated in KOOS pain, symptoms, sports, and ADL subscales (p < 0.001). Conclusions: Despite a relatively small sample, it was demonstrated that single IA AqueousJoint injection is a safe procedure, resulting in significant pain reduction, higher ADL score, and higher KOOS sport scores. The effects lasted up to 6 months.