Approach-Related Complications: Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
| Investigational Group | Control Group | P | |
|---|---|---|---|
| (N = 205) | (N = 99) | ||
| All approach related, no. (%) | 20 (9.8) | 10 (10.1) | .925 |
| Venous injury, no. (%) | 9 (4.4) | 2 (2.0) | |
| Retrograde ejaculation, no. (%)a | 3 (3.3) | 3 (5.5) | .515 |
| Ileus, no. (%) | 2 (1.0) | 1 (1.0) | |
| Perioperative vein thrombosis, no. (%) | 2 (1.0) | 0 | |
| Clinically significant blood loss >1500 mL, no. (%) | 1 (0.5) | 2 (2.0) | |
| Incisional hernia, no. (%) | 1 (0.5) | 2 (2.0) | |
| Epidural hematoma, no. (%) | 1 (0.5) | 0 | |
| Dural tear, no. (%) | 1 (0.5) | 0 | |
| Deep vein thrombosis, no. (%) | 0 | 0 | |
| Arterial thrombosis, no. (%) | 0 | 0 |
Note. Fisher's exact test was used to test categorical variables.
↵a Of 92 men in the investigational group and 55 men in the control group.