Article Figures & Data
Figures
- Fig. 1
Among patients who were reoperated, the percentage of those reoperations in each of the annual time periods. In the D+ILS group, reoperations occurred earlier than in the D+PS group.
- Fig. 2
Mean ODI scores improved significantly in both groups and remained improved throughout follow-up. Error bars represent the standard deviation.
- Fig. 3
Percentage of patients achieving ≥15 point decrease in ODI scores compared to baseline at each follow-up time point.
- Fig. 4
Mean VAS back pain scores (A) and worse leg pain scores (B) improved significantly in both groups and remained improved throughout follow-up. Error bars represent the standard deviation.
- Fig. 5
Zurich Claudication Questionnaire Scores on the symptom severity (A), physical function (B) and patient satisfaction (C) scales.
Tables
- 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 Reoperation Category D+ILS (N=215)
n (%)D+PS (N=107)
n (%)(1) Wound/surgery related 7 (3.3%) 1 (1.0%) (2) Under treatment 5 (2.3%) 2 (1.9%) (3) Device related issue 6 (2.8%) 7 (6.5%) (4) Device ineffective A. Early (≤ 2 years post-op) 7 (3.3%) 3 (2.8%) B. Late (> 2 years post-op) 9 (4.2%) 6 (5.6%) (5) Trauma 1 (0.5%) 0 Total 35 (16.3%) 19 (17.8%) Narcotics Usage D+ILS (%)
n=215D+PS (%)
n=107p (Fisher's Exact) Pre-op 52.6 53.3 >0.90 Week 6 46.0 54.2 >0.10 Month 3 34.4 44.9 >0.08 Month 6 29.8 34.6 >0.40 Month 12 28.0 38.3 >0.40 Month 18 22.3 29.0 >0.20 Month 24 23.3 33.6 >0.06 Month 36 23.3 22.4 >0.90 Month 48 23.7 20.6 >0.50 Month 60 23.7 24.3 >0.90
