A prospective multi-centre, open study of the safety and efficacy of hylan G-F 20 (Synvisc®) in patients with symptomatic ankle (talo-crural) osteoarthritis

Hyaluronate for the Treatment of Ankle Osteoarthritis

“…The incidence of adverse events was also low in the study by Cohen et al (Cohen et al, 2008), only one case of pseudogout, resolved without therapy, was observed in the Hyalgan group. Witteveen et al (Witteveen et al, 2008) reported 35 patients (63.6%) experienced a total of 89 adverse events in their study, which was relatively high compared with other studies. The majority of adverse events were arthralgia, injection site pain, and joint swelling, which were reported to be mild or moderate in intensity and transient in nature.…”

“…One limitation in this trial includes the absence of a control group, thus the placebo effects associated with joint injections per se were not analyzed. In the prospective case series by Witteveen et al, patients with symptomatic grade 2 (van Dijk et al scale) ankle OA (>50 and <90 mm on a 100 mm visual analog scale (VAS), were treated with intraarticular injection of Hylan GF-20 (Synvisc, 2 mL) plus an optional second injection if pain remained at baseline level after 1, 2 or 3 months, with 6-9-months follow-up period (Witteveen et al, 2008). The primary efficacy endpoint was the change from baseline in the Pain VAS Score at 3 months.…”

Hyaluronic Acid in the Treatment of Osteoarthritis: What is New

“…Clinical benefit was evaluated by means of different scales (Visual Analogic Scale, Ankle Osteoarthritis Scale, American Orthopaedic Foot and Ankle Society, Short Form -12, Short Form -36, Western Ontario and McMaster Universities Osteoarthritis Index), and the follow -up period varied from 6 to 18 months. In studies performed without control group (Hanson et al, 1999;Luciani et al, 2008;MeiDan et al, 2010;Sun et al, 2006;Valiveti et al, 2006;Witteveen et al, 2008Witteveen et al, , 2010 (Table 2), an improvement in all the outcome measures was reported, with the effect lasting for 18 months (Luciani et al, 2008). However, it is not clear from reports whether the pain reduction was clinically significant, or could be ascribed only to a placebo effect.…”

“…Only few studies have been performed in ankle osteoarthritis and, among these, four were randomized / controlled trials (level of evidence 1) (Carpenter & Motley, 2008;Cohen et al, 2008;Karatosun et al, 2008;Salk et al, 2005Salk et al, , 2006, while seven studies (Hanson et al, 1999;Luciani et al, 2008;Mei -Dan et al, 2010;Sun et al, 2006;Valiveti et al, 2006;Witteveen et al, 2008Witteveen et al, , 2010 were case series (level of evidence 4). In all these studies, patients suffering from post -traumatic Kellgreen -Lawrence grade II -IV ankle osteoarthritis were enrolled.…”

“…Another possible reason of the limited benefit of hyaluronic acid can be related to its use mostly in post -traumatic osteoarthritis (Zhang & Jordan, 2010), which has a pathogenesis quite different from that of primary degenerative osteoarthritis. Finally, it must be considered that all studies (Carpenter & Motley, 2008;Hanson et al, 1999;Karatosun et al, 2008;Luciani et al, 2008;Mei -Dan et al, 2010;Salk et al, 2005Salk et al, , 2006Sun et al, 2006;Valiveti et al, 2006;Witteveen et al, 2008Witteveen et al, , 2010, but one (Cohen et al, 2008), were performed blindly, with any imaging guidance. This can be a valid explanation of several unsatisfactory results, because there is evidence that about one third of intraarticular injections are not delivered into the intra -articular cavity, when performed without a visual aid (Cunnington et al, 2010).…”