To evaluate the safety and efficacy of a single intra-articular injection of 2%hyaluronic acid (HA) + mannitol in symptomatic knee osteoarthritis (KOA).
Pilot, multicentre, open, non-comparative study performed in eighty patients with painful KOA, of whom 79 completed the study. They received one injection of 2 ml of 2%HA + 0.5%mannitol (Day 0) and were followed-up for 6 months. On Days 0, 15, 30, 60, 90, 120, 150 and 180, pain and joint function were assessed using a visual analogue scale (VAS) and WOMAC index. Efficacy and safety by investigator and patient, and rescue medication, as an indirect measure of pain, were also recorded.
A significant reduction in joint pain, stiffness and functional disability compared with baseline was observed at every follow-up visit (
There is evidence that repeated intra-articular injections of HA improve symptoms in KOA. However, studies with a single injection of HA have shown mixed results. This study demonstrates that one single intra-articular injection of non-cross-linked HA reduces joint pain and increases function in patients with KOA over a period of at least 6 months.