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. 2010 May 28;19(8):1262–1280. doi: 10.1007/s00586-010-1445-3

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%)

Table based on the published manuscripts, number of compilation in FDA report [56, 58] deviated (see text)

aRetrograde ejaculation calculated for men only