Table 1

Month 60 overall efficacy of subjects achieving clinical success defined by the individual components of success.

Status pre-op compared with Month 60N assessedN meeting criterium%N assessedN meeting criterium%p-value
Improvement of≥15 points in ODI at Month 60 compared to baseline12410080.6554174.5>0.40
No reoperation or epidural steroid injection21514868.81077166.4>0.70
No reoperations, revisions, removals, or supplemental fixation21517983.31078983.2>0.90
No epidural injection at any lumbar level21517380.51078276.6>0.40
No persistent new or increasing sensory or motor deficit888394.34040100.0>0.30
No persistent new or increasing sensory deficit14814396.66666100.0>0.30
No persistent new or increasing motor deficit14614498.6747297.3>0.60
No major device-related complications21521298.610710295.3>0.10
Composite Clinical Success (Month 60 CCS-FDA)1919650.3914044.0>0.30