Table 5.
Overview complications trials
Prodisc® | Charité® | FlexiCore® | ||||
---|---|---|---|---|---|---|
Index (n = 162), 82 ♂ | Control (n = 80), 34 ♂ | Index (n = 205), 113 ♂ | Control (n = 99), 44 ♂ | Index (n = 44) | Control (n = 23) | |
Approach-related | 2 (2.4%)a | 2 (2.5%) | 16 (9.1%)a | 9 (12.8%)a | 1 (2.3%) | 0 |
Prosthesis related | 5 (3.1%) | 0 | 8 (3.9%) | 10 (10.1%) | 2 (4.5%) | 0 |
Treatment related | 1 (0.6%) | 0 | 17 (8.3%) | 23 (23.2%) | 5 (11.4%) | 8 (34.8%) |
General surgical related | 2 (1.2%) | 3 (3.8%) | 16 (7.8%) | 4 (4.0%) | 2 (4.5%) | 2 (8.7%) |
Total of complications | 10 (7.3%) | 5 (6.3%) | 57 (29.1%) | 46 (50.2%) | 10 (22.7%) | 10 (43.5%) |
Reoperation at index level | 6 (3.7%) | 4 (5.4%) | 11 (5.4%) | 9 (9.1%) | 5 (11.4%) | 6 (26.1%) |
13 (6.3%) | 10 (10.1%) |