TABLE 4.
Postoperative AEs
| List of postoperative AEs with frequency, n (%) | 3 months (n = 374) | 12 months (n = 296) |
|---|---|---|
| Cardiac arrest/failure/arrythmia | 10 (2.7) | 6 (2.0) |
| Construct failure with loss of correction | 2 (0.5) | 1 (0.3) |
| Construct failure without loss of correction | 2 (0.5) | 1 (0.3) |
| CSF leak/pseudomeningocele | 12 (0.5) | 8 (2.7) |
| Deep vein thrombosis | 10 (2.7) | 7 (2.4) |
| Deep wound infection | 21 (5.6) | 16 (5.4) |
| Delirium | 7 (1.9) | 6 (2.0) |
| Dysphagia | 7 (1.9) | 6 (2.0) |
| Dysphonia | 5 (1.3) | 5 (1.7) |
| Gastrointestinal bleeding | 2 (0.5) | 2 (0.7) |
| Hematoma | 7 (1.9) | 7 (2.4) |
| Myocardial infarction | — | — |
| Neurological deterioration (≥ 1 motor grade in ASIA motor scale) | 10 (2.7) | 9 (3.0) |
| Nonunion | — | 1 (0.3) |
| Pneumonia | 17 (4.5) | 15 5.1) |
| Postoperative neuropathic pain | 10 (2.7) | 7 (2.4) |
| Pressure sores | — | — |
| Pulmonary embolism | 14 (3.7) | 12 (4.1) |
| Superficial wound infection | 12 (3.2) | 11 (3.7) |
| Systemic infection | 6 (1.6) | 7 (2.4) |
| Urinary tract infection | 7 (1.9) | 7 (2.4) |
| Wound dehiscence | 19 (5.1) | 16 (5.4) |
| Others | 98 (26.2) | 89 (30.1) |
| Number of patients with at least 1 postoperative AE, n (%) | 117 (31.3) | 106 (35.8) |
| No. of patients with at least 1 AE (any), n (%) | 159 (42.5) | 137 (46.3) |
AE, adverse events; ASIA, American Spinal Injury Association; CSF, cerebrospinal fluid.