Table 2. Function, pain, and health-related quality of life outcomes following C-ADR versus fusion from two FDA trials with follow-up of 48 months or more.*.
| Mean difference in scores from preop to follow-up | |||||||
|---|---|---|---|---|---|---|---|
| Mean preop score | 60 mo | ||||||
| C-ADR (n = 276) | Fusion (n = 265) | C-ADR (n = 144) | Fusion (n = 127) | P† | |||
| Burkus et al 1 (2010) (N = 541) |
NDI | 55.7 | 56.4 | 38.4 | 34.1 | .022 | |
| Neck pain | 68.2 | 69.3 | 56.0 | 52.4 | NS | ||
| Arm pain | 59.1 | 62.4 | 52.5 | 47.7 | NS | ||
| SF-36 PCS | 31.9 | 32.0 | 14.7 | 12.9 | NS | ||
| Mean preop score | 48 mo | ||||||
| C-ADR (n = 242) | Fusion (n = 221) | C-ADR (n = 181) | Fusion (n =138) | P† | |||
| Sasso et al 2 (2011) (N = 463) | NDI | 51.4 ± 15.3 | 50.2 ± 15.9 | 39.0 ± 19.1 | 31.2 ± 21.3 | < .001 | |
| Neck pain | 75.4 ± 19.9 | 74.8 ± 23.0 | 54.0 ± 29.3 | 44.7 ± 33.6 | .001 | ||
| Arm pain | 71.2 ± 19.5 | 71.2 ± 25.1 | 55.5 ± 27.5 | 50.3 ± 35.9 | .028 | ||
| SF-36 PCS | 32.6 ± 6.7 | 31.8 ± 7.2 | 15.7 ± 11.1 | 13.1 ± 12.0 | .007 | ||
*
C-ADR indicates cervical artificial disc replacement; FDA, US Food and Drug Administration; NDI, Neck Disability Index; SF-36, Short-Form 36 Questionnaire; and PCS, Physical Component Score.
†
P values compare the mean improvement in scores from baseline to each follow-up time-point between C-ADR and fusion.