Table 1

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

	D+ILS			D+PS
Status pre-op compared with Month 60	N assessed	N meeting criterium	%	N assessed	N meeting criterium	%	p-value
Improvement of≥15 points in ODI at Month 60 compared to baseline	124	100	80.6	55	41	74.5	>0.40
No reoperation or epidural steroid injection	215	148	68.8	107	71	66.4	>0.70
No reoperations, revisions, removals, or supplemental fixation	215	179	83.3	107	89	83.2	>0.90
No epidural injection at any lumbar level	215	173	80.5	107	82	76.6	>0.40
No persistent new or increasing sensory or motor deficit	88	83	94.3	40	40	100.0	>0.30
No persistent new or increasing sensory deficit	148	143	96.6	66	66	100.0	>0.30
No persistent new or increasing motor deficit	146	144	98.6	74	72	97.3	>0.60
No major device-related complications	215	212	98.6	107	102	95.3	>0.10
Composite Clinical Success (Month 60 CCS-FDA)	191	96	50.3	91	40	44.0	>0.30