Intraarticular Hydrogel Arthrosemid vs. Steroid for Moderate to Severe Osteoarthritis Management

This study focuses on managing moderate to severe osteoarthritis in the knee without surgery. It compares the effects of a new intra-articular medication, Arthrosamid®, with the current standard care, which includes an intra-articular steroid and bupivacaine. The goal is to see if Arthrosamid® can provide better pain relief and improve knee function. Adults with symptomatic knee pain and a radiographic diagnosis of knee osteoarthritis are the target population. The study excludes individuals with inflammatory conditions, cancer, acute infection, pregnancy, uncontrolled diabetes, joint diseases, a history of knee surgery, or recent knee procedures or injections. Participants are randomly assigned to receive either Arthrosamid® or the standard care. The study measures the intensity of pain and knee function using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), a self-administered questionnaire, before the treatment, and then 3, 6, 12 months after, with a possibility of follow up at 18 months. The study also uses an EQ-5DL Health Questionnaire and a Visual numerical pain rating scale (VNS) to evaluate the results. Any adverse effects after the injection, such as pain, infection, or allergic reaction, are also monitored. MRI imaging with contrast of the injected knee is done before the procedure, and then 3, 6, 12 months after, with a possibility of follow up at 18 months.