Article Figures & Data
Figures
- Figure 1
(A) DASCOR delivery catheter and implant. (B) PerQdisc delivery device and implant.
- Figure 2.
Change in mean (± SEM) back-visual analog scale (VAS) baseline to 1 year for all groups and the comparison group (Ahrens et al9). *Difference between group A and B, P = 0.003.
- Figure 3.
Mean (± SEM) change in Oswestry Disability Index (ODI) baseline to 1 year for all groups and the comparison group (Ahrens et al9). *Difference between group A and B, P = 0.001.
- Figure 4
Baseline (BL), 1-year, and long-term follow-up (LTFU) patient-reported outcome measures reported as mean ± SEM. Back visual analog scale (VAS) reported in mm.
- Figure 5
Long-term magnetic resonance imaging (MRI) results, mean 11.5 years. T2-weighted midsagittal views.
Tables
Inclusion Criteria Age 21 to 70 years
Degenerative disc disease as evidenced by:
History, clinical and radiographic findings
Darkened disc on MRI
Decreased disc height compared to adjacent disc(s)
Positive discography at the affected level
One lumbar spine level condition from L2 to S1
Minimum disc height of 5.5 mm
Intact endplates at the affected disc level
Six months of failed nonoperative care
Patient is able to complete a 2-year follow-up visitation schedule
VAS score ≥5 on a 10-point scale
ODI score ≥40 on a 100-point scale
MRI, magnetic resonance imaging; ODI, Oswestry Disability Index; VAS, visual analog scale.
PROM Baseline 12 Months LTFU Mean (SEM) Mean (SEM) Mean Change vs Baseline (SEM) P Value Mean (SEM) Mean Change vs Baseline (SEM) P Value ODI 55.1 (3.4) 18.5 (3.7) −36.6 (19.0) <0.0001 21.7 (4.5) −33.4 (18.4) <0.0001 VAS back 7.6 (1.4) 2.2 (2.1) −5.4 (2.9) <0.0001 3.6 (2.6) −4.0 (2.8) <0.0001 ANS 1.3(0.9) 0.5 (0.6) −0.8 (1.1) 0.002 0.8 (1.2) −0.5 (1.4) 0.07 ANS, analgesic score; LTFU, long-term follow-up; ODI, Oswestry Disability Index; PROM, patient-reported outcome measure; VAS, visual analog scale.
Characteristic Group A (n = 8) Group B (n = 14) P Value Age, y, mean (SD) 38.5 (3.2) 32.6 (2.1) 0.061 Baseline ODI, mean (SD) 57.5 (4.6) 54.7 (3.6) 0.388 Baseline VAS back, mean (SD) 7.1 (0.4) 7.6 (0.4) 0.404 Baseline ANS, mean (SD) 1.3 (0.4) 1.3 (0.4) 0.357 Sex, M/F, n (%) 5 (63%)/3 (38%) 1 (7%)/13 (93%) Smoker, n (%) 1 (12.5%) 6 (43%) Level treated, n (%) L4/5 4 (50%) 9 (64%) L5/S1 4 (50%) 5 (36%) ANS, analgesic score; ODI, Oswestry Disability Index; VAS, visual analog scale.
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