Table 1 Demographics and patient characteristics at screening or baseline
Placebo (N = 220) | Single 6 ml Hylan G-F 20 injection (N = 220) | All (N = 440) | |
|---|---|---|---|
Gender [n (%)] | |||
Male | 48 (21.8) | 50 (22.7) | 98 (22.3) |
Female | 172 (78.2) | 170 (77.3) | 342 (77.7) |
Age (year) | |||
Mean (SD) | 61.6 (7.8) | 61.5 (7.9) | 61.5 (7.9) |
Median | 63.0 | 62.0 | 63.0 |
Min; Max | 42; 79 | 40; 79 | 40; 79 |
Age group [n (%)] | |||
< =60 | 79 (35.9) | 92 (41.8) | 171 (38.9) |
> 60 | 141 (64.1) | 128 (58.2) | 269 (61.1) |
Race [n (%)] | |||
Asian | 220 (100) | 220 (100) | 440 (100) |
Ethnicity [n (%)] | |||
Not Hispanic or Latino | 220 (100) | 220 (100) | 440 (100) |
Baseline BMI (kg/m2) | |||
Mean (SD) | 25.39 (3.29) | 25.57 (3.07) | 25.48 (3.18) |
Median | 25.39 | 25.23 | 25.28 |
Min; Max | 16.5; 36.2 | 18.3; 34.4 | 16.5; 36.2 |
Grade according to modified Kellgren-lawrence numerical [n (%)] | |||
0 | 0 | 0 | 0 |
I | 24 (10.9) | 31 (14.1) | 55 (12.5) |
II | 116 (52.7) | 105 (47.7) | 221 (50.2) |
III | 80 (36.4) | 84 (38.2) | 164 (37.3) |
IV | 0 | 0 | 0 |
WOMAC A1 score (0–10) | |||
Number | 220 | 220 | 440 |
Mean (SD) | 5.2 (1.3) | 5.3 (1.2) | 5.3 (1.3) |