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.