Systematic clinical evidence review of NASHA (Durolane hyaluronic acid) for the treatment of knee osteoarthritis

Abstract

Ross Leighton,1 Jane Fitzpatrick,2,3 Helen Smith,4 Daniela Crandall,4 Carl R Flannery,4 Thierry Conrozier5 1Department of Surgery, Dalhousie University, Halifax, NS, Canada; 2Sports Medicine Professionals Pty Ltd, Richmond, VIC, Australia; 3University of Western Australia, Perth, WA, Australia; 4Bioventus LLC, Durham, NC, USA; 5Department of Rheumatology, Hospital Nord Franche-Comte, Belfort, France Background: Pain and limitations in joint mobility associated with knee osteoarthritis (OA) are clinically challenging to manage, and advanced progression of disease can often lead to total knee arthroplasty. Intra-articular injection of hyaluronic acid (HA), also referred to as viscosupplementation, is a non-surgical treatment approach for OA, the effectiveness of which may depend on the HA composition, and the length of time over which it resides in the joint. One of the available options for such therapies includes NASHA (Durolane HA), a non-animal, biofermentation-derived product, which is manufactured using a process that stabilizes the HA molecules to slow down their rate of degradation and produce a unique formulation with a terminal half-life of ~1 month. The objectives of the current review were to assess, in patients with OA of the knee, the efficacy and safety of intra-articular treatment with NASHA relative to control (saline) injections, other HA products, and other injectables (corticosteroids, platelet-rich plasma, mesenchymal stem cells).Methods: This systematic evidence review examines patient outcomes following NASHA treatment as described in published data from studies conducted in subjects with knee OA. A Preferred Reporting Items for Systematic Reviews and Meta-analyses-compliant literature search strategy yielded 11 eligible clinical studies with a variety of comparator arms. Outcomes assessed at various time points following intra-articular treatment included measures of pain, function, quality of life, and incidence of treatment-related adverse events (AEs).Results: The available evidence reported for the clinical studies assessed demonstrates sustained and effective relief of knee OA symptoms following a single injection of NASHA. In addition, an excellent biocompatibility profile is observed for NASHA as an intra-articular therapy for OA, as reflected by the low rate of AEs associated with treatment.Conclusion: Treatment with NASHA is an effective and safe single-injection procedure, which can be beneficial in the clinical management of knee OA. Keywords: osteoarthritis, viscosupplementation, intra-articular, hyaluronic acid, NASHA, Durolane, residence time, symptomatic relief, clinical outcomes

Keywords

• Osteoarthritis
• Viscosupplementation
• Intra-articular
• Hyaluronic acid
• NASHA
• Durolane
• Residence time
• Symptomatic relief
• Clinical outcomes