Objectives: The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection of hylan G-F 20 was also assessed.
Methods: Patients with primary osteoarthritis knee pain were randomly assigned to arthrocentesis plus a 6 ml intra-articular injection of either hylan G-F 20 or placebo in a prospective, double-blind (one injector/one blinded observer) study. Results were evaluated at 4, 8, 12, 18 and 26 weeks post-injection. The primary outcome criterion was change from baseline over 26 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index A pain. Secondary outcome measures included WOMAC A1 and C, patient global assessment (PGA) and clinical observer global assessment (COGA) and Outcome Measures in Rheumatology, Osteoarthritis Research Society International responder rates. A 4-week, open, repeat treatment phase evaluated safety only.
Results: A total of 253 patients (Kellgren–Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC A pain scores (−0.15, SE 0.076, p = 0.047), and several of the secondary outcome measures (WOMAC A1, PGA and COGA), than patients receiving placebo. There was no difference between the safety results of the two groups. No increased risk of local adverse events was observed in the open, repeat treatment phase.
Conclusions: This placebo-controlled study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 26 weeks, with a modest difference versus placebo.
Trial registration number: NCT00131352.
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Funding This manuscript is based upon clinical trial results from a study sponsored by Genzyme Biosurgery.
Competing interests Declared. XC, JJ and PG have been reimbursed by Genzyme Biosurgery, the manufacturer of hylan G-F 20, for attending symposia and have also received speaker fees. JJ has received research funds from Genzyme Biosurgery. FB is an employee of Genzyme Biosurgery working in the Clinical Research and Medical Affairs Departments. NvD, FPL, DLS and KP have no conflicts of interest. All authors actively participated in the conduct of this trial and in its analysis and interpretation.
Ethics approval Ethics committee approvals were obtained.
Patient consent Obtained.
Provenance and Peer review Not commissioned; externally peer reviewed.