Article Figures & Data
Figures
- Figure 1
Fusion success at 12 months following pulsed electromagnetic field stimulation. (A) An overall successful fusion rate of 88.0% (n = 125/142) was observed following lumbar spinal fusion with adjunct pulsed electromagnetic field stimulation treatment. (B) A high rate of successful fusion was observed in patients presenting with single or multiple risk factors for pseudarthrosis.
- Figure 2
Impact of pulsed electromagnetic field stimulation on short form-36 mental and physical component scores. Significant improvements in short form-36 mental (P = 0.005) and physical (P < 0.001) component scores were observed at the 12-month time point.
- Figure 3
Impact of pulsed electromagnetic field stimulation on overall quality of life and disability index (EQ-5D). (A) A significant improvement in EQ-5D scores was observed at the 12-month time point (P < 0.0001). (B) A significant improvement in Oswestry Disability Index (ODI) scores was observed at the 12-month time point (P < 0.0001).
- Figure 4
Impact of pulsed electromagnetic field stimulation on overall visual analog scale (VAS)-back and VAS-leg pain scores. A significant improvement in VAS-back and VAS-leg pain scores was observed at the 12-month time point (P < 0.0001).
Tables
Variable n (%) Sex Female 79 (55.6%) Male 63 (44.4%) Ethnicity Hispanic/Latino 5 (3.5%) Not Hispanic/Latino 137 (96.5%) Race Caucasian or White 130 (91.5%) Black or African American 8 (5.6%) Other 4 (2.8%) BMI Mean (SD) 31.03 (5.94) Min–Max 17.16–44.19 BMI ≥30 79 (55.6%) BMI <30 63 (44.4%) Age, y Mean (SD) 63.27 (10.34) Min–Max 30–81 Age 65+ 76 (53.5%) Age <65 66 (46.5%) Abbreviation: BMI, body mass index.
Note: Data presented as n (%) unless otherwise noted.
Variable n (%) Number of risk factors 1 78 (54.9) ≥2 64 (45.1) ≥3 17 (12.0) ≥4 2 (1.4) Number of levels 1 10 (7.0) 2 71 (50.0) 3 39 (27.5) 4 11 (7.8) 5 5 (3.5) 7 1 (0.7) 8 2 (1.4) 9 2 (1.4) 15 1 (0.7) Variable Fusion Success
n/N (%)P BMI risk factor ≥30 72/79 (91.1%) 0.2 <30 53/63 (84.1%) Nicotine risk factor Smoker 22/27 (81.5%) 0.2 Nonsmoker 103/113 (92.9%) Age risk factor 65+ y 70/76 (92.1%) 0.1 <65 y 55/66 (83.3%) Diabetes risk factor Diabetes 27/32 (84.4%) 0.5 No diabetes 98/110 (89.1%) Osteoporosis risk factor Yes 11/14 (78.6%) 0.4 No 114/128 (89.1%) Prior fusion Yes 20/22 (90.9%) 1.0 No 105/120 (87.5%) Multiple levels Multiple 114/128 (89.1%) 0.4 Single 11/14 (78.6%) Abbreviation: BMI, body mass index.
AE Parameter Events, n (%) Total AEs 553 Total No. of patients with ≥1 AE 119 (53.1) AE severity Mild 312 (56.3) Moderate 170 (30.7) Severe 71 (12.8) AE relatedness Related 6 (1.1) Unrelated 547 (98.7) Description of AE Severity Action Taken Pain from screws Moderate No action taken Increase in diarrhea Moderate Temporarily discontinued use of device Postoperative ankle dorsiflexion weakness Moderate Ongoing Increased pain when wearing device Mild Ongoing Mild low back pain with device use Mild Resolved Increased back pain with some radicular pain through hips and groin Severe Resolved Abbreviation: AE, adverse event.
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