A Randomised Control Trial of an Intraarticular Hydrogel Arthrosamid® vs. Steroid Injection for Non-operative Management of Knee Osteoarthritis

What this Trial Is About

Researchers are conducting a randomized controlled trial to compare the effects of Arthrosamid®, a new intra-articular hydrogel implant, with the current standard treatment of steroid and local anesthetic injections for managing knee osteoarthritis. This study aims to evaluate which treatment better helps reduce pain and improve knee function in patients with symptomatic knee osteoarthritis confirmed by imaging. Approximately 200 patients will participate, split evenly between the two treatment groups. Participants will receive a single knee injection of either Arthrosamid®, a non-biodegradable 2.5% polyacrylamide hydrogel designed to cushion the joint and potentially delay surgery, or a steroid injection containing dexamethasone, methylprednisolone, and bupivacaine. The study is double-blinded, so neither patients nor researchers know which treatment is given. Follow-up visits will be scheduled at 3, 6, 12, and possibly 18 months after injection to monitor outcomes. During the study, participants will undergo assessments including MRI scans of the knee, functional evaluations, and questionnaires such as the Western Ontario and McMaster Universities Arthritis Index (WOMAC), EuroQol-5 Dimension-5 Level, and visual numerical pain rating scales. These measures will be collected before treatment and at follow-up visits to compare the effectiveness of the two treatments. Safety and treatment impact will be monitored throughout the study duration, which is expected to last until September 2027.

Arthrosamid vs. Steroid for the Management of Knee Osteoarthritis