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Nonanimal Hyaluronic Acid for the Treatment of Ankle Osteoarthritis: AProspective,Single-Arm Cohort Study
Institution:1. Professor, Department of Orthopaedics, University of British Columbia, Vancouver, Canada;2. Clinical Professor, Department of Orthopaedics, University of British Columbia, Vancouver, Canada;3. Associate Clinical Professor, Department of Orthopaedics, University of British Columbia, Vancouver, Canada;4. Clinical Associate Professor, Department of Orthopaedics, University of British Columbia, Vancouver, Canada;5. Statistical Analyst, Bioventus LLC, Durham, NC;6. Manager for Clinical Affairs, Bioventus LLC, Durham, NC;7. Director of Research, Research & Development, Bioventus Cooperatief UA, Hoofddorp, The Netherlands
Abstract:Ankle osteoarthritis (OA) can cause disabling symptoms, and some patients prefer to be treated with minimally invasive procedures. Nonanimal hyaluronic acid (NASHA) is a cross-linked hyaluronic acid product that has a prolonged intra-articular residence time. The authors report the first study of NASHA for the treatment of ankle OA. Thirty-seven patients with Kellgren-Lawrence grade II or III ankle OA received an intra-articular injection of NASHA (1 mL). Outcomes included visual analogue scale (VAS) scores for pain and disability. At baseline, the mean VAS pain score was 50.1 ± 14.5mm. During the 26-week follow-up period, the least squares (LS) mean change from baseline in the ankle OA VAS pain score was –20.5mm (95% confidence interval CI] ?25.5 to ?15.6 mm), an LS mean percentage reduction of 40.0% (95% CI 30.2% to 49.9%). The LS mean change from baseline in the VAS disability score during 26 weeks was ?19.2mm (95% CI ?24.8 to ?13.6 mm), a percentage reduction of 34% (95% CI 22.3% to 45.7%). Five participants experienced a total of 7 adverse events considered to be related to study treatment (injection site pain, n = 3; injection site joint pain, n = 3; plantar fasciitis, n = 1). This study shows promise for viscosupplementation with NASHA in the treatment of ankle OA. A single injection was associated with clinically meaningful reductions in pain and disability during a 26-week period and, in general, was well tolerated.
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