Fusion Treatment–Related Events, Device-Related Events, and Reoperation Index Level: Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
| Investigational Group (N = 205) | Control Group (N = 99) | P | |
|---|---|---|---|
| Fusion treatment related, no. (%) | 0 | 27 (27.3) | |
| Nonunion/pseudarthrosis | 0 | 9 (9.1) | |
| Bone graft donor site pain | 0 | 18 (18.2) | |
| Prosthesis related, no. (%) | 8 (3.9) | 1 (1.0) | .163 |
| Collapse or subsidence of implant into adjacent vertebrae | 7 (3.4) | 1 (1.0) | |
| Implant displacement | 1 (0.5) | 0 | |
| Additional surgery index level, no. (%) | 11 (5.4) | 9 (9.1) | .127 |
| Revision | 5 (2.4) | 0 | |
| Reoperation | 4 (2.0) | 8 (8.1) | |
| Removal | 2 (1.0) | 1 (1.0) |
Note. Fisher's exact test was used to test categorical variables.