| Placebo (n = 4) | PRG 3.9M (n = 8) | PRG 6.7M (n = 8) |
---|---|---|---|
Demographics | |||
 Age (years) | 55.0 ± 10.42 | 50.8 ± 7.29 | 55.0 ± 5.15 |
 Females | 3 (75%) | 2 (25%) | 3 (37.5%) |
 Height (cm) | 165.0 ± 7.87 | 172.6 ± 10.99 | 174.4 ± 11.99 |
 Weight (kg) | 69.8 ± 11.55 | 82.9 ± 12.44 | 81.9 ± 14.23 |
 BMI (kg/m2) | 25.5 ± 2.84 | 27.7 ± 2.05 | 26.8 ± 2.98 |
OA characteristics | |||
 Study knee KL OA grade 1 | 1 (25%) | 0 (0%) | 1 (12.5%) |
 Study knee KL OA grade 2 | 0 (0%) | 2 (25%) | 1 (12.5%) |
 Study knee KL OA grade 3 | 3 (75%) | 6 (75%) | 6 (75%) |
 OA in non-study knee | 3 (75%) | 7 (87.5%) | 6 (75%) |
Patient-reported outcomes | |||
 VAS pain score (0–100 mm) | 43.8 ± 7.41 | 57.0 ± 13.82 | 60.8 ± 13.01 |
 WOMAC pain score (0–20) | 6.3 ± 3.86 | 6.6 ± 2.07 | 7.9 ± 3.04 |
 WOMAC stiffness score (0–8) | 3.3 ± 2.06 | 3.4 ± 1.19 | 4.1 ± 1.89 |
 WOMAC physical functioning score (0–68) | 16.7 ± 10.69 | 22.0 ± 9.80 | 26.8 ± 10.20 |
 AQoL-4D utility score | 0.75 ± 0.213 | 0.80 ± 0.140 | 0.76 ± 0.183 |
Activity level (FitBit®; n = 18) | |||
 Average daily steps | 11,071 ± 7085 | 9049 ± 2605 | 11,934 ± 12,013 |
Quantitative MRI assessments | |||
 Cartilage volume (mm3) | |||
  Medial tibial region | 1597.1 ± 642.95 | 2037.0 ± 665.59 | 2166.0 ± 858.29 |
  Lateral tibial region | 1777.5 ± 532.24 | 2459.3 ± 836.59 | 2470.3 ± 784.52 |
  Patella | 2588.3 ± 965.59 | 2895.2 ± 1204.61 | 3637.1 ± 1431.01 |
 Tibial bone area (mm2) | |||
  Medial region | 2045.9 ± 374.36 | 2567.4 ± 388.86 | 2727.2 ± 632.68 |
  Lateral region | 1508.3 ± 364.83 | 1641.3 ± 368.14 | 1611.9 ± 582.25 |
 Bone marrow lesions | |||
  Medial tibiofemoral region | 1 (25%) | 4 (50%) | 8 (100%) |
  Lateral tibiofemoral region | 1 (33.3%) | 4 (50%) | 2 (25%) |
  Patella | 2 (50%) | 3 (37.5%) | 1 (12.5%) |
 Cartilage defects | |||
  Medial tibiofemoral region | 3 (75%) | 8 (100%) | 7 (100%)* |
  Lateral tibiofemoral region | 4 (100%) | 8 (100%) | 7 (100%)* |
  Patella | 3 (75%) | 6 (75%) | 6 (85.7%) |
Biomarkers | |||
 Urine CTX-II (ng/mmol) | 336.8 ± 311.34 | 149.9 ± 44.45 | 230.9 ± 136.69 |
 Urine C2C (ng/mmol) | 1591.6 ± 715.73 | 2388.9 ± 1616.07 | 1049.0 ± 1026.84 |
 Serum HA (ng/mL) | 32.6 ± 6.32 | 49.7 ± 19.95 | 47.0 ± 24.05 |
 Serum MIF (ng/mL) | 12.9 ± 3.32 | 13.2 ± 5.34 | 15.5 ± 2.86 |
 Serum CTX-I (ng/mL) | 0.3 ± 0.08 | 0.3 ± 0.15 | 0.4 ± 0.10 |