Table 1

Baseline characteristics for all randomly assigned patients (ITT population)

Hylan G-F 20 (N  =  124)Placebo (N  =  129)
Mean age, years (SD)63.6 (9.64)62.5 (9.17)
Mean BMI, kg/m2 (SD)29.08 (4.81)29.77 (5.74)
Gender (M/F)32/9241/88
Tibiofemoral compartment with the most severe features of osteoarthritis, N* (%)
    Medial93 (75.6)103 (79.2)
    Lateral30 (24.4)27 (20.8)
Modified Kellgren–Lawrence grade in most severe tibiofemoral compartment, N* (%)
    Grade II63 (51.2)51 (39.2)
    Grade III60 (48.8)78 (60.0)
    Grade IV01 (0.8)
Previous corticosteroids in the target knee, N* (%)40 (32)31 (24)
Previous arthroscopy in the target knee, N* (%)26 (21)28 (22)
Total WOMAC score (0–4), mean (SD)2.30 (0.44)2.28 (0.39)
WOMAC A score (0–4), mean (SD)2.30 (0.43)2.25 (0.41)
Symptomatic osteoarthritis that was responsive to paracetamol and did not require other therapy, N* (%)
    In the contralateral knee68 (55.3)76 (58.5)
    In either hip12 (9.8)18 (13.8)
Mean time since osteoarthritis diagnosis, months* (SD) (median, range)77.38 (76.44) (51.94, 3.1–350.9)70.01 (64.43) (47.34, 3.6–241.9)
  • *Safety population. BMI, body mass index; ITT, intent-to-treat; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.