| Literature DB >> 31157151 |
Meghan Cerpa1, Lawrence G Lenke1, Michael G Fehlings2, Christopher I Shaffrey3, Kenneth M C Cheung4, Leah Yacat Carreon5.
Abstract
STUDYEntities:
Keywords: deformity; fusion; neuro; revision surgery; scoliosis
Year: 2019 PMID: 31157151 PMCID: PMC6512199 DOI: 10.1177/2192568219828729
Source DB: PubMed Journal: Global Spine J ISSN: 2192-5682
Study Inclusion and Exclusion Criteria.
| Inclusion criteria |
Signed informed consent Age 18 to 80 years old, inclusive Diagnosis of adult spinal deformity (ASD) with an
apex of the major deformity in the cervicothoracic
or thoracolumbar region (apex between C7 and L2,
inclusive) with any of the following deformity
characteristics: Primary scoliosis, kyphosis or kyphoscoliosis
with a major Cobb angle ≥80° in the coronal or
sagittal plane Congenital spinal deformity undergoing
corrective spinal osteotomy Revision spinal deformity undergoing corrective
spinal osteotomy Any patient undergoing a 3-column spinal osteotomy (ie, pedicle subtraction osteotomy, vertebral column resection) from C7 to L5, inclusive Any patient with preoperative myelopathy due to their spinal deformity Any patient with ossification of the ligamentum flavum or posterior longitudinal ligament and a deformity that needs concomitant reconstruction along with decompression of the spinal cord |
| Exclusion criteria |
Unlikely to comply with follow-up Recent history ≤3 months of substance dependency or psychosocial disturbance Presence of active malignancy Has active, overt bacterial infection, systemic or local Recent (≤3 months) history of significant spinal trauma/injury/fracture/malignancy in the spinal region Patients with complete, long-term paraplegia Pregnant or nursing women; women unable to agree not to become pregnant for a period of 6 months after surgery Prisoners Institutionalized individuals |
Demographics and Surgical Characteristics.
| Variable | Type of Lower Extremity Motor Score (LEMS) Decline at Discharge | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Normal vs Abnormal |
| Unilateral vs Bilateral |
| Minor vs Major |
| ||||
| Normal (n = 203) | Abnormal (n = 68) | Unilateral (n = 32) | Bilateral (n = 29) | Minor (n = 41) | Major (n = 20) | ||||
| Gender, n (%) | |||||||||
| Male | 60 (29.6) | 29 (42.7) | .053 | 6 (18.8) | 15 (51.7) | .007 | 12 (29) | 11 (55) | .225 |
| Female | 143 (70.4) | 39 (57.4) | 26 (81.3) | 14 (48.3) | 29 (71) | 9 (45) | |||
| Age, years, mean ± SD | 56.3 ± 15.9 | 58.8 ± 13.2 | .236 | 63.1 ± 10.5 | 60.7 ± 10.1 | .367 | 61.5 (56.0, 69.5)a | 63.0 (57.0, 70.0)a | .424 |
| Smoker, n (%) | |||||||||
| No | 184 (91.1) | 59 (88.1) | .478 | 31 (96.9) | 25 (86.2) | .182 | 37 (90) | 19 (95) | — |
| Yes | 18 (8.9) | 8 (11.9) | 1 (3.1) | 4 (13.8) | 4 (10) | 1 (5) | |||
| Previous surgery | |||||||||
| No | 86 (42.4) | 16 (23.5) | .006 | 10 (31.3) | 8 (27.6) | .754 | 12 (29) | 6 (30) | .953 |
| Yes | 117 (57.6) | 52 (76.5) | 22 (68.8) | 21 (72.4) | 29 (71) | 14 (70) | |||
| Preoperative neurologic deficit | |||||||||
| No | 203 (100) | 0 (0) | — | 23 (71.9) | 21 (72.4) | .963 | 32 (78) | 12 (60) | .140 |
| Yes | 0 (0) | 68 (100) | 9 (28.1) | 8 (27.6) | 9 (22) | 8 (40) | |||
| Surgical approach | |||||||||
| Posterior only | 154 (75.9) | 53 (77.9) | .869 | 21 (65.6) | 27 (93.1) | .009 | 33 (80) | 15 (75) | .741 |
| Anterior + posterior | 49 (24.1) | 15 (22.1) | 11 (34.4) | 2 (6.9) | 8 (20) | 5 (25) | |||
| No. of stages | |||||||||
| Single | 165 (81.3) | 55 (80.9) | 1.000 | 25 (78.1) | 24 (82.8) | .649 | 32 (78) | 17 (85) | .734 |
| Multi (≥2) | 38 (18.7) | 13 (19.1) | 7 (21.9) | 5 (17.2) | 9 (22) | 3 (15) | |||
a Presented as median (interquartile range).
Change in Lower Extremity Motor Score (LEMS) Compared With Baseline by Group.
| Change in LEMS Compared with Baseline | Total (n = 271) | Normal Group (n = 203) | Abnormal Group (n = 68) |
|
|---|---|---|---|---|
| Discharge, n (%) | 265 | 199 | 66 | .542a |
| Maintenance/Improvement | 204 (77) | 155 (77.9) | 49 (74.2) | |
| Decline | 61 (23) | 44 (22.1) | 17 (25.8) | |
| 6 weeks, n (%) | 258 | 194 | 64 | .677a |
| Maintenance/Improvement | 214 (83) | 162 (83.5) | 52 (81.3) | |
| Decline | 44 (17.1) | 32 (16.5) | 12 (18.8) | |
| 6 months, n (%) | 252 | 190 | 62 | 0.293a |
| Maintenance/Improvement | 227 (90.1) | 169 (89) | 58 (93.6) | |
| Decline | 25 (9.9) | 21 (11.1) | 4 (6.5) | |
| 24 months, n (%) | 209 | 163 | 46 | 0.417b |
| Maintenance/Improvement | 188 (90) | 148 (90.8) | 40 (87) | |
| Decline | 21 (10.1) | 15 (9.2) | 6 (13) |
a Chi-square test.
b Fisher’s exact test.
Nonneurological Adverse Events.
| Nonneurological Adverse Events | n | % (95% CI) |
|---|---|---|
| Any of the nonneurological adverse events specified below | 184 | 67.6 (61.7-73.2) |
| Stroke | 0 | 0.0 (0.0-1.3) |
| Cardiac arrest | 1 | 0.4 (0.0-2.0) |
| Surgery related | 108 | 39.7 (33.8-45.8) |
| Cerebrospinal fluid leak | 2 | 0.7 (0.1-2.6) |
| Dural tear | 43 | 15.8 (11.7-20.7) |
| Screw malposition | 7 | 2.6 (1.0-5.2) |
| Loss of correction | 18 | 6.6 (4.0-10.3) |
| Implant failure | 40 | 14.7 (10.7-19.5) |
| Pedicle fracture | 1 | 0.4 (0.0-2.0) |
| Laminar fracture | 0 | 0.0 (0.0-1.3) |
| Visceral injury | 6 | 2.2 (0.8-4.7) |
| Vascular injury | 1 | 0.4 (0.0-2.0) |
| Excessive bleeding | 14 | 5.1 (2.8-8.5) |
| Graft dislodgement | 1 | 0.4 (0.0-2.0) |
| Graft donor site pain | 1 | 0.4 (0.0-2.0) |
| Intraoperative coagulopathy | 3 | 1.1 (0.2-3.2) |
| Visual field deficits/loss | 0 | 0.0 (0.0-1.3) |
| Malignant hyperthermia | 0 | 0.0 (0.0-1.3) |
| Anesthetic complication | 4 | 1.5 (0.4-3.7) |
| Wound infection | 26 | 9.6 (6.3-13.7) |
| Deep infection | 12 | 4.4 (2.3-7.6) |
| Superficial infection | 8 | 2.9 (1.3-5.7) |
| Graft site infection | 2 | 0.7 (0.1-2.6) |
| Wound dehiscence/Stitch abscess | 7 | 2.6 (1.0-5.2) |
| Gastrointestinal | 11 | 4.0 (2.0-7.1) |
| Superior mesenteric artery syndrome | 0 | 0.0 (0.0-1.3) |
| Ileus | 11 | 4.0 (2.0-7.1) |
| Deep vein thrombosis | 8 | 2.9 (1.3-5.7) |
| Pulmonary embolism | 3 | 1.1 (0.2-3.2) |
| Respiratory | 14 | 5.1 (2.8-8.5) |
| Pneumonia | 10 | 3.7 (1.8-6.7) |
| Atelectasis | 6 | 2.2 (0.8-4.7) |
| Urogenital | 37 | 13.6 (9.8-18.3) |
| Urinary retention | 10 | 3.7 (1.8-6.7) |
| Retrograde ejaculation | 0 | 0.0 (0.0-1.3) |
| Urinary tract infection | 30 | 11.0 (7.6-15.4) |
| Other | 119 | 43.8 (37.8-49.9) |