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. 2012 Feb;3(Suppl 1):59–66. doi: 10.1055/s-0031-1298610

Table 4. Subsequent operations following C-ADR versus fusion from two FDA trials with follow-up of 48 months or more.*.

Burkus et al 1 (2010), 60 mo Sasso et al 2 (2011), 48 mo
C-ADR (n = 276) Fusion (n = 265) P C-ADR (n = 242) Fusion (n = 221) P
Revisions 0% (0) 1.9% (5) .028 0.4% (1) 0% (0) NS
Hardware removal 2.5% (7) 4.9% (13) NS 1.7% (4) 1.8% (4) NS
Supplemental fixation 0% (0) 1.9% (5) .028 0% (0) 2.3% (5) NS
External bone growth stimulator 0% (0) 2.6% (7) .007 0% (0) 0.9% (2) NS
Reoperation 1.4% (4) 0.8% (2) NS 1.7% (4) 0.5% (1) NS
*

C-ADR indicates cervical artificial disc replacement; FDA, US Food and Drug Administration; and NS, not statistically significant.