Mtskheta

This research aims to evaluate the safety and performance of ABIO3419 in treating knee osteoarthritis, a chronic joint disease marked by cartilage damage, joint space narrowing, bone changes, and inflammation. Knee osteoarthritis also involves a reduction in the amount and quality of hyaluronic acid in joint fluid, leading to poor joint lubrication and inflammation. The study is a randomized, controlled, prospective, and multicenter clinical trial designed to compare ABIO3419 against a comparator treatment for knee osteoarthritis symptoms. Participants will receive intra-articular injections of viscosupplement gel, which contains hyaluronic acid to help improve joint function and reduce pain. The treatment involves injections directly into the knee joint. The study includes two arms and is single-blinded, meaning participants do not know which treatment they receive. The trial monitors treatment effects and safety over time, including a follow-up period of 3 months after the last injection. During the study, participants will undergo evaluations focusing on knee pain while walking on flat ground, assessed at 3 months after the last injection. Researchers will collect clinical and radiographic data, monitor adverse events, and assess joint function and pain levels. The study also requires participants to comply with study procedures and attend scheduled visits for assessments and monitoring. The total participation period includes the treatment phase and follow-up assessments to evaluate the treatment's performance and safety.