Week 26 subscore | Estimate of OR (placebo/hylan G-F 20) (95% CI) | |||
Hylan G-F 20 n (%) | Placebo n (%) | At week 26 | Over 26 weeks | |
WOMAC A1 (walking pain) subscore | ||||
None | 17 (13.7) | 13 (10.1) | 0.56 (0.35 to 0.92) p = 0.022 | 0.64 (0.45 to 0.91) p = 0.013 |
Mild | 45 (36.3) | 39 (30.2) | ||
Moderate | 41 (33.1) | 42 (32.6) | ||
Severe | 11 (8.9) | 19 (14.7) | ||
Extreme | 1 (0.8) | 4 (3.1) | ||
Patient global assessment | ||||
Very well | 9 (7.3) | 2 (1.6) | 0.51 (0.31 to 0.82) p = 0.005 | 0.69 (0.50 to 0.96) p = 0.029 |
Well | 33 (26.6) | 27 (20.9) | ||
Fair | 50 (40.3) | 54 (41.9) | ||
Poor | 21 (16.9) | 31 (24.0) | ||
Very poor | 2 (1.6) | 3 (2.3) | ||
Clinician observer global assessment | ||||
Very well | 13 (10.5) | 8 (6.2) | 0.56 (0.34 to 0.93) p = 0.025 | 0.71 (0.50 to 0.99) p = 0.041 |
Well | 37 (29.8) | 31 (24.0) | ||
Fair | 38 (30.6) | 38 (29.5) | ||
Poor | 22 (17.7) | 34 (26.4) | ||
Very poor | 5 (4.0) | 6 (4.7) | ||
OMERACT–OARSI responders | ||||
Responder | 73 (58.9) | 66 (51.2) | 0.69 (0.41 to 1.16) p = 0.156 | 0.66 (0.44 to 1.02) p = 0.059 |
Non-responder | 50 (40.3) | 63 (48.8) | ||
Based on OMERACT–OARSI responder criteria | 43 (34.7) | 52 (40.3) | ||
Due to withdrawal before study completion | 7 (5.6) | 11 (8.5) |
ITT, intent-to-treat; OMERACT–OARSI, Outcome Measures in Rheumatology, Osteoarthritis Research Society International; OR, odds ratio; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.