Table 4

Secondary efficacy endpoints (ITT population): estimates of odds ratios

Week 26 subscoreEstimate of OR (placebo/hylan G-F 20) (95% CI)
Hylan G-F 20 n (%)Placebo n (%)At week 26Over 26 weeks
WOMAC A1 (walking pain) subscore
    None17 (13.7)13 (10.1)0.56 (0.35 to 0.92) p = 0.0220.64 (0.45 to 0.91) p = 0.013
    Mild45 (36.3)39 (30.2)
    Moderate41 (33.1)42 (32.6)
    Severe11 (8.9)19 (14.7)
    Extreme1 (0.8)4 (3.1)
Patient global assessment
    Very well9 (7.3)2 (1.6)0.51 (0.31 to 0.82) p = 0.0050.69 (0.50 to 0.96) p = 0.029
    Well33 (26.6)27 (20.9)
    Fair50 (40.3)54 (41.9)
    Poor21 (16.9)31 (24.0)
    Very poor2 (1.6)3 (2.3)
Clinician observer global assessment
    Very well13 (10.5)8 (6.2)0.56 (0.34 to 0.93) p = 0.0250.71 (0.50 to 0.99) p = 0.041
    Well37 (29.8)31 (24.0)
    Fair38 (30.6)38 (29.5)
    Poor22 (17.7)34 (26.4)
    Very poor5 (4.0)6 (4.7)
OMERACT–OARSI responders
Responder73 (58.9)66 (51.2)0.69 (0.41 to 1.16) p = 0.1560.66 (0.44 to 1.02) p = 0.059
Non-responder50 (40.3)63 (48.8)
    Based on OMERACT–OARSI responder criteria43 (34.7)52 (40.3)
    Due to withdrawal before study completion7 (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.