Objective:
First, to assess the clinical effectiveness of hylan g-f 20 in an appropriate care treatment regimen (as defined by the american college of rheumatology (acr) 1995 guidelines) as measured by validated disease-specific outcomes and health-related quality of life endpoints for patients with osteoarthritis (oa) of the knee. second, to utilize the measures of effectiveness and costs in an economic evaluation (see accompanying manuscript).
Design:
A total of 255 patients with oa of the knee were enrolled by rheumatologists or orthopedic surgeons into a prospective, randomized, open-label, 1-year, multi-centred trial, conducted in canada. patients were randomized to 'appropriate care with hylan g-f 20' (ac+h) or 'appropriate care without hylan g-f 20' (ac). data were collected at clinic visits (baseline, 12 months) and by telephone (1, 2, 4, 6, 8, 10, and 12 months).
Results:
The ac+h group was superior to the ac group for all primary (% reduction in mean western ontario and mcmaster universities osteoarthritis index (womac) pain scale: 38% vs 13%,p =0.0001) and secondary effectiveness outcome measures. these differences were all statistically significant and exceeded the 20% difference between groups set a priori by the investigators as the minimum clinically important difference. health-related quality of life improvements in the ac+h group were statistically superior for the womac pain, stiffness and physical function (all p< 0.0001), the sf-36 aggregate physical component (p< 0.0001) and the health utilities index mark 3 (hui3) overall health utility score (p< 0.0001). safety (adverse events and patient global assessments of side effects) differences favoured the ac+h group.
Conclusion:
The data presented here indicate that the provision to patients with knee oa of viscosupplementation with hylan g-f 20 within an appropriate care treatment regimen provides benefits in the knee, overall health and health related quality of life at reduced levels of co-therapy and systemic adverse reactions.