Table 3. Serious Surgery-Associated Adverse Eventsa.
| Event | No. | Mean difference in proportions posterior vs anterior (95% CI) | ||
|---|---|---|---|---|
| Posterior (n = 119) | Anterior (n = 124) | Total (n = 243) | ||
| Total | 9 | 8 | 17 | NA |
| Dysphagia or globus sensationb | 1 | 6 | 7 | –0.03 (–0.09 to 0.01) |
| Hoarsenessb | 1 | 2 | 3 | –0.01 (–0.04 to 0.03) |
| Implant malpositionc | NA | 1 | 1 | NA |
| New radicular arm pain without need for surgeryd | 1 | 4 | 5 | –0.02 (–0.07 to 0.02) |
| Persistent radicular arm pain without need for surgeryd | 8 | 2 | 10 | 0.05 (–0.01 to 0.10) |
| Nonradicular symptomse | 0 | 1 | 1 | –0.02 (–0.05 to 0.01) |
| Neck pain | 2 | 1 | 3 | 0.01 (–0.03 to 0.04) |
| Shoulder symptomsf | 9 | 5 | 14 | 0.04 (–0.03 to 0.10) |
| Neck and shoulder symptomsg | 0 | 3 | 3 | –0.02 (–0.06 to 0.01) |
| Cardiothoracic symptomsh | 1 | 0 | 1 | 0.01 (–0.02 to 0.03) |
| Respiratory symptomsi | 0 | 1 | 1 | –0.01 (–0.03 to 0.02) |
| Wound infectionj | 5 | 2 | 7 | 0.03 (–0.02 to 0.08) |
| Allergic reaction to antibioticsk | 1 | 0 | 1 | 0.01 (–0.02 to 0.03) |
| Urinary retention | 1 | 0 | 1 | 0.01 (–0.02 to 0.03) |
| Total | 30 | 28 | 58 | NA |
| Serious adverse events | ||||
| Unresolved dysphagia within 1 y | 0 | 1 | 1 | –0.01 (–0.03 to 0.02) |
| Reoperation | ||||
| Index levell | 4 | 2 | 6 | 0.02 (–0.03 to 0.06) |
| Adjacent level | 0 | 2 | 2 | –0.02 (–0.05 to 0.01) |
| Index and adjacent level | 2 | 0 | 2 | 0.02 (–0.01 to 0.05) |
| Wound infectionj | 2 | 1 | 3 | 0.01 (–0.03 to 0.04) |
| Lung embolus | 0 | 1 | 1 | –0.01 (–0.03 to 0.02) |
| Postoperative hematomak | 1 | 1 | 2 | 0.00 (–0.02 to 0.02) |
Abbreviation: NA, not applicable.
Depicted are serious adverse events reported at the complication level (not patient level). Regarding the association with surgery, serious adverse events were rated as being 0 = definitely associated, 1 = probably associated, 2 = possibly associated, 3 = remotely associated, or 4 = not associated. Only serious adverse events scored as 0, 1, or 2 are depicted in this table. Adverse events were considered serious if they resulted in death, were life threatening, required prolongation of hospitalization, resulted in considerable disability, were a congenital anomaly or birth defect, or any other medically important event that jeopardized the patient or required an intervention.
Dysphagia was temporary in 6 patients and unresolved within 1 year in 1 patient in the anterior surgery group. Hoarseness was temporary in 2 patients in the anterior surgery group. Dysphagia and hoarseness in the posterior surgery group were temporary.
This patient had a slight cage subsidence without symptoms at 6 weeks. No reoperation was performed.
These were new or persistent radicular symptoms without reoperation within 1 year of follow-up. Some of these patients were treated with a selective nerve root blockage, referral to a pain center or pain specialist, or were treated conservatively.
This patient had arm pain without signs of radiculopathy.
Shoulder symptoms included patients with shoulder pain, frozen shoulder, or tendinitis supraspinatus. Some of these patients were treated with a local steroid injection.
Two patients had a combination of neck and shoulder pain after reoperatation.
This was a patient with palpitations during hospitalization.
This was a patient with dyspnea during hospitalization.
This includes patients with wound infections or leakage or swelling of the wound. When reported as an adverse event, wound infection was superficial and treated with oral antibiotics. When reported as serious adverse event, a longer hospitalization was required. None of the wound infections were related to esophageal injury.
This complication occurred during the operation (allergic reaction) or during hospitalization (postoperative hematoma).
One patient in the posterior surgery group had a reoperation at index level for new symptoms at the contralateral side.