A Prospective Study of Non-Animal Stabilized Very High Molecular Weight Hyaluronic Acid (NASHA) Intra-Articular Injections in Hemophilc Patients with Ankle Arthropathy

Background: Hemophilic arthropathy is the consequence of recurrent joint bleeds in patients affected by severe hemophilia A or B or von Willebrand disease, leading to functional limitations and chronic pain with negative impact on quality of life. Main target joints are knees, ankles, and elbows. Few therapeutic options are available for ankle arthropathy. Temporary symptom improvements have been reported by repeated (i.e., 3–5) intra-articular administrations of hyaluronic acid (HA). A non-animal stabilized very-high molecular weight HA formulation (NASHA) has been proven to achieve long-term benefits in patients with knee and hip osteoarthritis. Methods: Patients with ankle arthropathy undergoing a single NASHA (Durolane 0.5 ml, Smith & Nephew) injection were prospectively studied. Clinical assessment, including Gilbert Score (Pain, PGS, and physical examination, PEGS), pain scores (Visual Anologue scale, VAS and McGill Score, MGS), generic quality-of-life evaluation (EQ5D), and magnetic resonance imaging (MRI) were performed at baseline (T0) and 1 (T1), 6 (T6), and 12 (T12)months after NASHA injection. Results: Fifteen ankles in 9 patients (7 severe, 2 moderate; age: 21–45 years) were treated. A significant improvement of symptoms and functional outcome was reported at T1 compared to T0 (PGS: 0.5 ± 0.6 vs. 1.7 ± 1.0, P = 0.03; PEGS: 2.2 ± 2.8 vs. 4.7 ± 3.3, P = 0.001; VAS: 18 ± 19 vs. 71 ± 26; MGS: 0.8 ± 0.7 vs. 2.8 ± 1.1; P < 0.001; EQ5D: 80 ± 14 vs. 54 ± 25, P = 0.015). Data were not statistically different at T6 versus T1, suggesting long-term benefits after NASHA injection. Only 4 patients reached T12 at the time of this paper. The positive-experienced outcomes led to repeat treatment in these 4 patients 13 months (mean) after the first injection. No significant change in the European magnetic resonance imaging Score was found throughout the study. Conclusions: NASHA viscosupplementation enabled long-lasting clinical benefits and improvements of quality-of-life in patients with ankle arthropathy. This single-injection treatment provides an approach reducing risks and costs of multiple intra-articular injections, is well accepted by patients, and has a favourable cost-utility ratio.