THE ROLE OF VISCOSUPPLENENTATION WITH HYLAN G-F-20 (SYNVISC(R)) IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE - A CANADIAN MULTICENTER TRIAL COMPARING HYLAN G-F-20 ALONE, HYLAN G-F-20 WITH NONSTEROIDAL ANTIINFLAMMATORY DRUGS (NSAIDS) AND NSAIDS ALONE

To determine the safety and efficacy of viscosupplementation with hyla n G-F 20, a cross-linked hyaluronan preparation, used either alone or in combination with continuous non-steroidal anti-inflammatory drug (N SAID) therapy, a randomized, controlled, multicenter clinical trial, a ssessed by a blinded assessor, was conducted in 102 patients with oste oarthritis (OA) of the knee. All patients were on continuous NSAID the rapy for at least 30 days prior to entering the study. Patients were r andomized into three parallel groups: (1) NSAID continuation plus thre e control arthrocenteses at weekly intervals; (2) NSAID discontinuatio n but with three weekly intra-articular injections of hylan G-F 20; an d (3) NSAID continuation plus three injections, one every week, intra- articular injections of hylan G-F 20. Outcome measures of pain and joi nt function were evaluated by both the patients and an evaluator at ba seline and weeks 1, 2, 3, 7 and 12, with a follow-up telephone evaluat ion at 26 weeks. At 12 weeks all groups showed statistically significa nt improvements from baseline, but did not differ from each other. A s tatistical test for equivalence, the q-statistic, demonstrated that vi scosupplementation with hylan G-F 20 was at least as good or better th an continuous NSAID therapy for all outcome measurements except activi ty restriction. At 26 weeks both groups receiving hylan G-F 20 were si gnificantly better than the group receiving NSAIDs alone. A transient local reaction was observed in three patients after hylan G-F 20 injec tion; only one patient withdrew from the study as a result and all rec overed without any sequela. Hylan G-F 20 is a safe and effective treat ment for OA of the knee and can be used either as a replacement for or an adjunct to NSAID therapy.