TABLE 1.
Randomized vs. Preference | Randomized Arm (Never or Not Yet Crossed-Over) | Preference Arm | |||||
P | Brace | Observation | P | Brace | Observation | P | |
Baseline | (n = 64) | (n = 68) | (n = 135) | (n = 52) | |||
BMI | 0.25 | 19.5 (3.9) | 18.9 (3.4) | 0.20 | 19.2 (3.3) | 19.7 (3.2) | 0.27 |
Largest Cobb angle | 0.16 | 29.7 (4.7) | 29.3 (5.7) | 0.66 | 28.9 (5.8) | 27.7 (6.0) | 0.19 |
QOL | 0.07 | 82.2 (14.6) | 83.4 (12.6) | 0.81 | 85.7 (12.6) | 85.5 (11.7) | 0.76 |
Self-body | 0.11 | 17.6 (4.8) | 18.1 (4.2) | 0.63 | 16.9 (3.9) | 18.1 (4.7) | 0.03 |
Ideal-body | 0.11 | 21.1 (10.4) | 19.2 (10.4) | 0.25 | 18.4 (10.2) | 17.9 (10.1) | 0.53 |
Self-ideal | 0.07 | 38.1 (13.3) | 37.1 (12.6) | 0.64 | 35.1 (12.7) | 36.0 (13.0) | 0.68 |
6 months | (n = 62) | (n = 59) | (n = 125) | (n = 61) | |||
BMI | 0.05 | 19.7 (3.6) | 19.2 (4.5) | 0.21 | 19.7 (3.4) | 20.1 (3.4) | 0.37 |
Largest Cobb angle | 0.19 | 29.1 (8.7) | 33.7 (8.1) | 0.009 | 29.6 (8.3) | 30.8 (7.6) | 0.42 |
QOL | 0.01 | 82.6 (15.2) | 81.8 (13.9) | 0.56 | 86.4 (11.8) | 86.7 (11.2) | 0.98 |
Self-body | 0.07 | 17.8 (4.4) | 17.8 (4.9 | 0.79 | 16.8 (4.2) | 16.9 (4.6) | 0.82 |
Ideal-body | 0.35 | 20.5 (10.8) | 20.5 (10.9) | 0.94 | 20.1 (10.4) | 16.8 (9.2) | 0.03 |
Self-ideal | 0.16 | 38.3 (13.5) | 38.3 (13.5) | 0.96 | 36.9 (12.6) | 33.8 (11.7) | 0.12 |
12 months | (n = 57) | (n = 50) | (n = 119) | (n = 59) | |||
BMI | 0.08 | 19.5 (2.7) | 20.0 (4.4) | 0.99 | 19.8 (3.1) | 21.1 (3.6) | 0.009 |
Largest Cobb angle | 0.37 | 30.2 (9.6) | 37.0 (9.3) | 0.002 | 31.6 (10.4) | 34.0 (9.2) | 0.08 |
QOL | 0.01 | 82.2 (14.0) | 83.1 (12.4) | 0.96 | 86.1 (13.6) | 85.9 (5.4) | 0.94 |
Self-body | 0.10 | 18.9 (4.5) | 19.1 (5.8) | 0.96 | 17.7 (4.7) | 18.9 (9.6) | 0.19 |
Ideal-body | 0.31 | 21.3 (10.7) | 19.7 (9.5) | 0.51 | 19.8 (10.8) | 18.5 (9.6) | 0.55 |
Self-ideal | 0.18 | 40.2 (13.5) | 38.8 (13.3) | 0.56 | 37.7 (12.9) | 37.4 (13.6) | 0.89 |
18 months | (n = 48) | (n = 41) | (n = 93) | (n = 64) | |||
BMI | 0.53 | 19.6 (2.4) | 20.5 (3.3) | 0.32 | 20.1 (2.9) | 20.9 (3.7) | 0.30 |
Largest Cobb angle | 0.15 | 31.2 (9.4) | 37.8 (7.4) | 0.002 | 32.4 (10.1) | 35.2 (9.2) | 0.10 |
QOL | 0.32 | 84.8 (10.9) | 83.0 ((15.1) | 0.63 | 86.3 (11.7) | 85.0 (13.0) | 0.56 |
Self-body | 0.09 | 17.9 (4.5) | 20.1 (6.4) | 0.16 | 17.5 (4.2) | 18.8 (6.3) | 0.42 |
Ideal-body | 0.60 | 18.9 (10.5) | 20.9 (10.2) | 0.34 | 19.4 (10.7) | 18.6 (10.1) | 0.81 |
Self-ideal | 0.43 | 36.8 (13.1) | 41.0 (14.6) | 0.16 | 37.0 (12.7) | 37.4 (13.1) | 0.80 |
24 months | (n = 30) | (n = 37) | (n = 72) | (n = 50) | |||
BMI | 0.87 | 20.1 (2.9) | 21.3 (3.3) | 0.11 | 20.1 (2.6) | 21.5 (4.0) | 0.06 |
Largest Cobb angle | 0.39 | 31.9 (10.3) | 38.3 (8.3) | 0.008 | 31.9 (10.5) | 37.0 (9.8) | 0.01 |
QOL | 0.11 | 82.3 (15.1) | 79.8 (15.4) | 0.52 | 86.4 (12.2) | 81.9 (15.5) | 0.14 |
Self-body | 0.82 | 17.6 (5.0) | 19.7 (6.5) | 0.22 | 17.4 (4.0) | 20.5 (5.6) | 0.002 |
Ideal-body | 0.58 | 22.1 (11.9) | 21.0 (10.8) | 0.63 | 20.0 (9.8) | 19.7 (9.8) | 0.74 |
Self-ideal | 0.50 | 39.8 (15.0) | 40.7 (14.8) | 0.73 | 37.4 (11.4) | 40.2 (14.0) | 0.35 |
Note: Values are Means (±SD) and P values are two-sided. BMI indicates body mass index; QOL, quality of life.