Non-Animal Stabilised Hyaluronic Acid in the Treatment of Osteoarthritis of the Knee: A Tolerability Study
Full list of Authors
Åkermark C, Berg P, Bjorkman A, Malm P.
Full AMA reference
Åkermark C., Berg P., Bjorkman A., & Malm P. (2002). Non-animal stabilized hyaluronic acid in the treatment of osteoarthritis of the knee: A tolerability study. Clinical Drug Investigation, 22(3), 157-166.
Level-III clinical study: multi centre, non-blinded, prospective tolerability study with extension phase.
Primarily to evaluate the safety of an intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis (OA) of the knee, with an extension phase to assess the safety of a second repeat injection.
103 patients (128 knees) with arthroscopically verified OA were treated with a single injection of DUROLANE. Patients were followed up 2 weeks and 3 months post injection. VAS was measured at each clinic visit and overall satisfaction was measured at the 3 month follow up. After the first injection 7 of the reported local reactions fulfilled the criteria to be classed as a device related adverse event (AE) (knee pain and swelling). 53 patients received a second injection (6.5-9.5 months after first injection), this was followed up 1 month later. After the second injection 11 events were considered potentially related to the study product or the injection procedure, of which three were classed as device-related, unanticipated adverse events, giving an event frequency of 4% in 72 injections. A statistically significant reduction in knee pain (p < 0.0001) was seen after both injections.