Table 3.
Patient Parameter | Serious Adverse Event | P2 | |
---|---|---|---|
No (n=107) | Yes (n=66) | ||
Age, yrs, mean (SD) | 59.1 (9.1) | 60.8 (8.2) | 0.189 |
BMI, mean (SD) | 26.7 (4.7) | 27.9 (5.5) | 0.140 |
Male gender | 10 (9.4%) | 10 (15.2%) | 0.246 |
Race | 0.556 | ||
White | 104 (97.2%) | 62 (93.9%) | |
Black | 2 (1.9%) | 3 (4.6%) | |
Other | 1 (0.9%) | 1 (1.5%) | |
Currently working/employed3 | 64 (59.8%) | 34 (51.5%) | 0.285 |
Baseline comorbidities | |||
Autoimmune | 5 (4.7%) | 12 (18.2%) | 0.004 |
Cancer | 15 (14.0%) | 15 (22.7%) | 0.142 |
Cardiac disease | 5 (4.7%) | 5 (7.6%) | 0.427 |
Circulatory disorders, arterial | 3 (2.8%) | 2 (3.0%) | 0.931 |
Circulatory disorders, venous | 1 (0.9%) | 4 (6.1%) | 0.051 |
History of depression/anxiety/psychiatric disorder | 37 (34.6%) | 24 (36.4%) | 0.811 |
Diabetes mellitus | 3 (2.8%) | 7 (10.6%) | 0.033 |
Gastrointestinal (ulcer, stomach) | 6 (5.6%) | 12 (18.2%) | 0.009 |
Hypertension | 46 (43.0%) | 28 (42.4%) | 0.942 |
Infection history | 6 (5.6%) | 0 (0%) | 0.050 |
Lung disease/Asthma | 9 (8.4%) | 8 (12.1%) | 0.426 |
Nervous system disorder | 2 (1.9%) | 0 (0%) | 0.264 |
Renal disease | 2 (1.9%) | 1 (1.5%) | 0.862 |
Substance use | |||
Current or former tobacco/nicotine use | 36 (33.6%) | 30 (45.5%) | 0.120 |
Current or former alcohol/drug use | 5 (4.7%) | 2 (3.0%) | 0.594 |
Coronal plane, mean (SD) | |||
Lumbar Cobb, ° | 53.6 (14.5) | 57.2 (16.2) | 0.140 |
Fractional Cobb, ° | 22.5 (10.4) | 23.8 (10.5) | 0.443 |
Coronal balance (absolute value), mm | 24.6 (20.3) | 28.2 (30.9) | 0.403 |
Thoracic curve >30 °, % | 59 (55.1%) | 38 (57.6%) | 0.754 |
Sagittal plane, mean (SD) | |||
Global sagittal alignment, mm | 34.3 (42.7) | 39.8 (50.9) | 0.465 |
Pelvic incidence, ° | 55.5 (11.6) | 55.4 (10.1) | 0.952 |
Pelvic tilt, ° | 23.8 (9.1) | 24.7 (9.1) | 0.582 |
PI-LL mismatch | 18.9 (17.4) | 20.6 (20.0) | 0.587 |
Baseline PROs | |||
SRS-22 subscore | 3.1 (0.5) | 2.9 (0.6) | 0.019 |
Oswestry Disability Index | 35.1 (13.9) | 43.3 (16.0) | <0.001 |
NRS back pain | 6.2 (2.3) | 6.4 (2.1) | 0.491 |
NRS leg pain | 3.4 (3.0) | 4.8 (2.8) | 0.004 |
SF-12 Mental Component Score | 51.6 (10.8) | 47.4 (11.6) | 0.020 |
SF-12 Physical Component Score | 34.5 (9.4) | 31.0 (8.9) | 0.016 |
Surgical procedure | |||
Staged procedure | 8 (7.5%) | 6 (9.1%) | 0.705 |
Number vertebra instrumented, mean (SD) | 11 (4) | 12 (4) | 0.287 |
3-column osteotomy | 5 (7.6%) | 5 (4.7%) | 0.427 |
Combined anterior-posterior | 10 (9.4%) | 8 (12.1%) | 0.561 |
EBL, mL, mean (SD) | 1909 (1595) | 2704 (1750) | 0.003 |
Operative time, min, mean (SD) | 406 (140) | 439 (126) | 0.114 |
SD = standard deviation; BMI = body mass index; global sagittal alignment was assessed based on the C7–S1 sagittal vertical axis; PI = pelvic incidence; LL = lumbar lordosis; PRO = patient report outcome measure; SRS = Scoliosis Research Society; NRS = numeric rating scale score; 3-column osteotomy includes pedicle subtraction osteotomy and vertebral column resection; EBL = estimated blood loss
P-values from chi-squared tests for categorical variables and t-tests for continuous variables. Missing values included the following: coronal balance missing for 1 patient with no serious adverse event (SAE), fractional Cobb missing for 3 patients with no SAE and 1 patient with SAE; PI-LL mismatch missing for 2 patients with no SAE and 6 patients with SAE; pelvic tilt missing for 2 patients with no SAE and 6 patients with SAE; pelvic incidence missing 2 patients with no SAE and 6 patients with SAE; sagittal balance missing for 1 patient with no SAE
Includes part-time and full-time homemaker