Neurological Complications: Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
| Investigational Group (N = 205) | Control Group (N = 99) | P | |
|---|---|---|---|
| All neurological complications, no. (%) | 33 (16.1) | 17 (17.2) | .813 |
| Major, no. (%) | 9 (4.4) | 4 (4.0) | .888 |
| Burning or dysthetic pain | 5 (2.4) | 3 (3.0) | |
| Motor deficit—index level related | 3 (1.5) | 1 (1.0) | |
| Nerve root injury | 1 (0.5) | 0 | |
| Minor, no. (%) | 20 (9.8) | 8 (8.1) | |
| Numbness—index level related | 20 (9.8) | 7 (7.1) | |
| Numbness lower sacral root distribution | 0 | 1 (1.0) | |
| Other, no. (%) | 8 (3.9) | 8 (8.1) | |
| Numbness—non-index level-related | 5 (2.4) | 4 (4.0) | |
| Reflex change | 2 (1.0) | 2 (2.0) | |
| Positive Waddell signs | 1 (0.5) | 1 (1.0) | |
| Mechanical signs (SLR) | 0 | 1 (1.0) |
Note. SLR = straight leg raise. Fisher's exact test was used to test categorical variables.