Table 2 Baseline demographic, clinical, and imaging characteristics of the placebo group according to absence or presence of meniscal extrusion and bone marrow lesions (modified intention-to-treat sample, n = 330)
Ext- (n = 86) | Ext+ (n = 26) | |||||
|---|---|---|---|---|---|---|
BML- (n = 68) | BML+ (n = 18) | P -value | BML- (n = 14) | BML+ (n = 12) | P -value | |
Demographic and clinical | ||||||
Age, years | 61 ± 7 | 64 ± 10 | 0.493 | 65 ± 7 | 65 ± 10 | >0.999 |
Female, n (%) | 47 (69%) | 10 (56%) | 0.279† | 9 (64%) | 10 (83%) | 0.275† |
Body mass index, kg/m2 | 30 ± 4 | 30 ± 3 | 0.824 | 31 ± 7 | 27 ± 3 | 0.116 |
WOMAC | ||||||
Pain (0 to 100) | 37.4 ± 22.7 | 39.2 ± 19.0 | 0.587 | 48.5 ± 19.2 | 32.8 ± 18.2 | 0.053 |
Function (0 to 100) | 40.7 ± 22.5 | 35.5 ± 22.3 | 0.449 | 46.6 ± 22.6 | 28.7 ± 19.5 | 0.021 |
Stiffness (0 to 100) | 41.4 ± 26.3 | 43.7 ± 16.3 | 0.834 | 50.8 ± 17.5 | 41.4 ± 21.1 | 0.208 |
Total (0 to 300) | 120.9 ± 67.5 | 119.6 ± 55.8 | 0.871 | 149.4 ± 51.5 | 102.9 ± 53.5 | 0.024 |
VAS pain (0 to 100 mm) | 50.4 ± 25.6 | 41.3 ± 23.1 | 0.126 | 56.9 ± 17.2 | 51.3 ± 20.8 | 0.425 |
Imaging | ||||||
Kellgren-Lawrence, n (%) | 0.039 † | 0.391† | ||||
Grade 1 | - | - | - | - | ||
Grade 2 | 54 (79%) | 10 (56%) | 7 (50%) | 4 (33%) | ||
Grade 3 | 14 (21%) | 8 (44%) | 7 (50%) | 8 (67%) | ||
Joint space width, mm | 3.68 ± 0.74 | 3.37 ± 0.85 | 0.125 | 3.28 ± 0.55 | 2.99 ± 0.42 | 0.207 |
MRI, mm3 | ||||||
Global knee | 11247 ± 3151 | 11292 ± 2218 | 0.622 | 10930 ± 1749 | 9952 ± 2694 | 0.190 |
Femur | 7725 ± 2264 | 7956 ± 1621 | 0.321 | 7748 ± 1225 | 6989 ± 1664 | 0.129 |
Plateau | 3522 ± 943 | 3336 ± 700 | 0.803 | 3182 ± 591 | 2962 ± 1060 | 0.456 |
Medial compartment | 5334 ± 1525 | 5288 ± 1065 | 0.746 | 5355 ± 841 | 4479 ± 1155 | 0.095 |
Medial femur | 3766 ± 1089 | 3752 ± 750 | 0.549 | 3818 ± 550 | 3388 ± 783 | 0.068 |
Medial plateau | 1568 ± 471 | 1537 ± 384 | >0.999 | 1538 ± 336 | 1390 ± 384 | 0.247 |