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) | 32/92 | 41/88 |
| Tibiofemoral compartment with the most severe features of osteoarthritis, N* (%) | ||
| Medial | 93 (75.6) | 103 (79.2) |
| Lateral | 30 (24.4) | 27 (20.8) |
| Modified Kellgren–Lawrence grade in most severe tibiofemoral compartment, N* (%) | ||
| Grade II | 63 (51.2) | 51 (39.2) |
| Grade III | 60 (48.8) | 78 (60.0) |
| Grade IV | 0 | 1 (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 knee | 68 (55.3) | 76 (58.5) |
| In either hip | 12 (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.