Infection Complications: Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
| Investigational Group (N = 205) | Control Group (N = 99) | P | |
|---|---|---|---|
| All infection complications, no. (%) | 26 (12.7) | 8 (8.1) | .233 |
| Superficial wound with incision site pain, no. (%) | 13 (6.3) | 2 (2.0) | .103 |
| Other non-wound related, no. (%) | 5 (2.4) | 1 (1.0) | |
| Urinary tract infection, no. (%) | 5 (2.4) | 1 (1.0) | |
| Wound swelling, no. (%) | 2 (1.0) | 0 | |
| Pulmonary complication, no. (%) | 1 (0.5) | 0 | |
| Peritonitis, no. (%) | 0 | 1 (1.0) | |
| Iliac crest donor site, no. (%) | 0 | 3 (3.0) |
Note. Fisher's exact test was used to test categorical variables