Safety and efficacy of intra-articular injections of a combination of hyaluronic acid and mannitol (HAnOX-M) in patients with symptomatic knee osteoarthritis: Results of a double-blind, controlled, multicenter, randomized trial

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222 patients with OARSI grades 1-3 knee osteoarthritis were randomized to intra-articular viscosupplementation with either an intermediate-molecular-weight hyaluronic acid plus mannitol, an antioxidant, (HAnOX-M), or high-molecular-weight hyaluronic acid (Bio-HA). The purpose of this study was to evaluate if the HAnOX-M group demonstrated non-inferior results on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function sub-scores compared to the Bio-HA group over 26-week follow-up. Results suggested non-inferiority of the HAnOX-M group compared to the Bio-HA group for both outcome measures.