Article Figures & Data
Figures
- Fig. 1
Graphical illustration of VCF Treatment System, consisting of a percutaneously introduced nitinol coil guidewire advanced through a deployment cannula (A) and then fully coiled within the cancellous portion of the fractured vertebral body (B). A radiopaque polyetheretherketone implant is delivered incrementally over the removable coil (C) in a continuous loop to form a nesting, cylindrical column providing vertical displacement that may result in endplate re-elevation and fracture reduction (D).
- Fig. 2
Fluoroscopic images illustrating deployment of the implant into a vertebral body over the removable guidewire in a coiled manner (A). After removal of the coil, the implant is fully deployed (B) to provide structural support to the vertebral body and serve as a conduit for bone cement placement. After bone cement delivery through the lumen of the implant, lateral (C) and anteroposterior (D) fluoroscopic images show contained interdigitation of cement into the adjacent cancellous bone, and the fracture is fully stabilized in situ.
- Fig. 3
Line graph showing mean (± SE) VAS pain and ODI scores at baseline and each follow-up interval after vertebral augmentation.
- Fig. 4
Box-and-whisker plots indicating the upper (75th) and lower (25th) quartiles and the median value for percent improvement in VAS back pain severity (left) and ODI (right) scores at 6 weeks, 3 months, and 12 months after vertebral augmentation. The points at the end of the “whiskers” represent the 90th and 10th percentile values.
- Fig. 5
Mean and 95% confidence interval values for improvement in back pain severity by VAS derived from 4 separate meta-analyses of balloon kyphoplasty studies compared with the 12-month mean reduction in VAS pain scores for patients treated with the VCF Treatment System.
- Fig. 6
(A) Intraoperative lateral fluoroscopic image showing moderate vertebral wedging with percutaneous initial catheter introduction. (B) Immediate postoperative image in the same patient showing complete implant deployment with cement containment.
Tables
Characteristic Value Age (mean ± SD) (y) 71.9 ± 10.4 Female [n (%)] 46 (80.7) Body mass index* (mean ± SD) (kg/m2) 26.5 ± 4.4 Duration of symptoms [n (%)] <6 wk 29 (50.9) 6 wk to <3 mo 10 (17.5) 3 mo to <6 mo 7 (12.3) 6–12 mo 11 (19.3) No. of treated levels [n (%)] 1 51 (89.5) 2 5 (8.8) 3 1 (1.7) Pre-existing medical conditions† [n (%)] None 15 (26.3) Metabolic 9 (15.8) Cardiovascular 22 (38.6) Diabetes 3 (5.3) Gastrointestinal 13 (22.8) Osteoporosis, arthritis 7 (12.3) Pain severity score on VAS* (mean ± SD) (mm) 79.3 ± 17.2 ODI‡ (mean ± SD) (%) 68.1 ± 16.9
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