Table 4.
All (n=105) |
No SAE (n=78) |
SAE (n=27) |
P value | |
---|---|---|---|---|
SRS-22r Pain (%) | 54.3 | 50.0 | 66.7 | 0.134 |
SRS-22r Function (%) | 26.7 | 25.6 | 29.6 | 0.686 |
SRS-22r Self Image (%) | 32.4 | 35.9 | 22.2 | 0.191 |
SRS-22r Mental Health (%) | 36.2 | 43.6 | 14.8 | 0.010 |
SRS-22r Subscore (%) | 29.5 | 30.8 | 25.9 | 0.634 |
Oswestry Disability Index (%) | 9.5 | 10.3 | 7.4 | 1.000 |
SF-12 Mental Component Score (%) | 31.4 | 34.6 | 22.2 | 0.217 |
SF-12 Physical Component Score (%) | 34.3 | 32.1 | 40.7 | 0.437 |
SAE=Serious Adverse Event; SRS=Scoliosis Research Society
MCID thresholds: SRS-22r (0.4), ODI (10), SF-12 (5)17