Effects and Safety of Intra-Articular Sodium Hyaluronate Injection for the Treatment of Ankle Osteoarthritis: A Prospective Clinical Trial

Abstract

Various nonoperative treatments have been implemented to reduce pain and improve the quality of life in patients with ankle osteoarthritis. Among these treatments, intra-articular hyaluronate injection has proven efficacy and safety in patients with knee osteoarthritis. The purpose of this study was to evaluate the efficacy and complications of hyaluronate injection using various clinical scoring systems. This study included 37 patients with unilateral ankle osteoarthritis (grade 2 or 3 according to the Takakura classification) who did not respond to previous pharmacological treatment. 3 weekly hyaluronate injections (2 mL Hyruan Plus®) were administered. The efficacy of intra-articular hyaluronate injection was evaluated on the basis of patient-reported foot and ankle clinical assessment at a mean follow-up of 13.8 ± 8.3 (range 6-33) months. Ankle Osteoarthritis Scale scores for pain and disability, American Orthopedic Foot and Ankle Society ankle-hindfoot scores, and visual analog scale for pain significantly improved at the final follow-up compared to that before intra-articular hyaluronate injection (p ≤ .05). When patients were dichotomized according to age, sex, body mass index, symptom duration, and Takakura classification, all these factors were not related to clinical outcomes. This study suggests that 3 weekly intra-articular hyaluronate injections can be performed safely to reduce pain and improve function without serious complications in patients with early or intermediate-grade ankle osteoarthritis when patients inadequately respond to medication. Larger controlled studies are needed to clarify the effects of hyaluronate injection and identify patients who can benefit most from hyaluronate injection.