HA-Complexes Thermally–Stabilized with Mannitol in Treatment of Gonarthrosis

INTRODUCTION: Hyaluronic acid (HA) is a natural glycosaminoglycan which is an integral component of both the matrix of articular cartilage and synovial fluid with its unique rheological properties that are lost in gonarthrosis, which leads to a decrease of viscoelastic characteristics of the synovia and destruction of the cartilage. AIM: To evaluate the effectiveness and safety of the use of Hyapro sterile biopolymer synovial fluid prosthesis in a disposable syringe for intra-articular injection at a concentration of 1.5% — 2 ml in treatment of gonarthrosis. MATERIALS AND METHODS: From September 2020 to April 2022 at settings of the orthopedic department of Ryazan Regional Clinical Hospital, an open prospective non-comparative study of the effectiveness and safety of Hyapro sterile biopolymer synovial fluid prosthesis at a concentration of 1.5% — 2 ml in 30 patients with 2 to 3 stage gonarthrosis according to Kellgren–Lawrence scale was carried out. Prior to the treatment, and also 3 and 6 months after, the severity of clinical symptoms on VAS, WOMAC, Leken scales, the quality of life according to SF-36 questionnaire were registered; the biochemical markers namely cartilaginous oligomatrix peptide (COMP), metal matrix proteinase 3 (MMR 3) were determined with the use of StatFax enzyme-linked plate analyzer (Awareness Technology, USA). RESULTS: In general, the studied drug was well tolerated by patients: there were no typical for intra-articular injections cases of clinically important adverse reactions like prolonged pain at the injection site, expansion-like sensation, an elevation of local temperature, and changes in the color of skin or changes of the shape of the knee joint. Just transient local tenderness in 6.7% of injection cases was noted. We revealed a statistically significant decrease in serum MMR-3 levels by 6 months of follow-up, which reflects a reduction of the inflammatory component in osteoarthritis of the joint studied. Besides, a gradual increase in COMP levels by the 6th month of the study was found, which may be an evidence of activation of the protein after the course of treatment to replenish the cartilage matrix. The results on VAS, WOMAC scales, and Leken algofunctional index demonstrated similar positive dynamics: a statistically reliable decrease in such parameters as pain, stiffness, and impaired functioning by the 3rd month of follow-up compared with the initial level; this trend was remaining in 6 months. After 3 months of treatment, there was a reliable improvement of the quality of life on the subscale of the physical component of health compared with the initial level, which persisted until the end of the study. On the subscale of the psychological component of health, no changes were found during the period. CONCLUSION: The course use of Hyapro biopolymer synovial fluid prosthesis on the basis of hyaluronic acid thermally stabilized with mannitol, in symptomatic gonarthrosis of intermediate stages, permits safely and effectively reduce pain and the inflammatory response, improve the function of the affected joint through restoration of viscoelastic and protective properties of synovial fluid for up to at least 6 months, improving the quality of life of patients.