Table 3.
Baseline demographic, clinical, and imaging characteristics in the treatment groups according to the absence or presence of meniscal extrusion (Ext)
Strontium ranelate 1 g/day | Strontium ranelate 2 g/day | Placebo | P -value | Placebo versus Strontium ranelate 1 g/day | Placebo versus Strontium ranelate 2 g/day | |
---|---|---|---|---|---|---|
P -value | P -value | |||||
Ext- | n = 94 | n = 90 | n = 86 | |||
Demographic and clinical | ||||||
Age, years | 60 ± 7 | 63 ± 7 | 62 ± 8 | 0.045* | 0.961** | 0.548** |
Female, n (%) | 63 (67%) | 61 (68%) | 57 (66%) | 0.978† | ||
Body mass index, kg/m2 | 30.0 ± 5.0 | 29.8 ± 9.9 | 32.4 ± 8.1 | 0.187* | ||
WOMAC | ||||||
Pain (0 to100) | 40 ± 20 | 44 ± 21 | 38 ± 22 | 0.107* | ||
Function (0 to 100) | 42 ± 21 | 42 ± 24 | 40 ± 22 | 0.732* | ||
Stiffness (0 to 100) | 46 ± 23 | 48 ± 26 | 42 ± 24 | 0.294* | ||
Total (0 to 300) | 130 ± 59 | 132 ± 64 | 121 ± 65 | 0.446* | ||
VAS pain (0 to 100 mm) | 50 ± 22 | 54 ± 24 | 48 ± 25 | 0.204* | ||
Imaging | ||||||
Kellgren-Lawrence, n (%) | 0.943† | |||||
Grade 1 | - | - | - | |||
Grade 2 | 71 (76%) | 66 (73%) | 64 (74%) | |||
Grade 3 | 23 (24%) | 24 (27%) | 22 (26%) | |||
Joint space width, mm | 3.61 ± 0.82 | 3.67 ± 0.81 | 3.61 ± 0.77 | 0.707* | ||
Presence of BML, n (%) | 23 (24%) | 20 (22%) | 18 (21%) | 0.847† | ||
MRI, mm3 | ||||||
Global knee | 11256 ± 2920 | 11520 ± 3344 | 11256 ± 2968 | 0.911* | ||
Femur | 7759 ± 2121 | 8000 ± 2286 | 7773 ± 2139 | 0.750* | ||
Plateau | 3497 ± 886 | 3520 ± 1158 | 3483 ± 897 | 0.855* | ||
Medial compartment | 5391 ± 1374 | 5547 ± 1577 | 5325 ± 1435 | 0.655* | ||
Medial femur | 3797 ± 1020 | 3937 ± 1098 | 3763 ± 1023 | 0.540* | ||
Medial plateau | 1594 ± 405 | 1610 ± 541 | 1562 ± 452 | 0.726* | ||
Ext+ | n = 19 | n = 15 | n = 26 | |||
Demographic and clinical | ||||||
Age, years | 61 ± 6 | 61 ± 8 | 65 ± 8 | 0.228* | ||
Female, n (%) | 7 (37%) | 9 (60%) | 19 (73%) | 0.051 † | 0.045** | >0.999** |
Body mass index, kg/m2 | 30.7 ± 4.7 | 32.2 ± 6.4 | 29.3 ± 6.0 | 0.164* | ||
WOMAC | ||||||
Pain (0 to100) | 50 ± 21 | 50 ± 16 | 41 ± 20 | 0.320* | ||
Function (0 to 100) | 47 ± 21 | 45 ± 19 | 38 ± 23 | 0.593* | ||
Stiffness (0 to 100) | 52 ± 24 | 57 ± 17 | 46 ± 19 | 0.252* | ||
Total (0 to 300) | 147 ± 58 | 153 ± 46 | 127 ± 57 | 0.394* | ||
VAS pain (0 to 100 mm) | 56 ± 19 | 58 ± 19 | 54 ± 19 | 0.837* | ||
Imaging | ||||||
Kellgren-Lawrence, n (%) | 0.158† | |||||
Grade 1 | - | - | - | |||
Grade 2 | 6 (32%) | 2 (13%) | 11 (42%) | |||
Grade 3 | 13 (68%) | 13 (87%) | 15 (58%) | |||
Joint space width (mm) | 2.91 ± 0.75 | 2.80 ± 0.35 | 3.15 ± 0.51 | 0.110* | ||
Presence of BML, n (%) | 8 (42%) | 3 (20%) | 12 (46%) | 0.232† | ||
MRI, mm3 | ||||||
Global knee | 12345 ± 3367 | 12838 ± 2972 | 10479 ± 2243 | 0.032* | 0.193** | 0.050** |
Femur | 8497 ± 2192 | 8962 ± 2100 | 7398 ± 1465 | 0.044* | 0.274** | 0.062** |
Plateau | 3848 ± 1281 | 3875 ± 1051 | 3081 ± 830 | 0.029* | 0.100** | 0.071** |
Medial compartment | 5707 ± 1520 | 5845 ± 1305 | 5089 ± 1020 | 0.208* | ||
Medial femur | 4013 ± 958 | 4136 ± 945 | 3619 ± 689 | 0.176* | ||
Medial plateau | 1695 ± 624 | 1708 ± 397 | 1470 ± 360 | 0.295* |
Results are shown as mean ± SD unless otherwise indicated. *P-values assessed using the Kruskal-Wallis test; **P-values assessed using the **Mann-Whitney test with Bonferroni adjustment for multiple comparisons; P-values assessed using the †chi-square test for categorical variables. Statistically significant P-values are in bold. Ext, meniscal extrusion; n, number of participants; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index (each subscale, 100 = worst score; total scale, 300 = worst score); VAS, visual analog scale (0 mm = no pain, 100 mm = most severe pain); BML, bone marrow lesions MRI, magnetic resonance imaging.