Clinical Outcomes for 52 Patients Treated with V-STRUT® Transpedicular Device for Osteoporotic and Pathologic Vertebral Compression Fractures in the United States.

BACKGROUND

In patients presenting with a vertebral compression fracture, there is minimal published data on safety and efficacy outcomes for the novel V-STRUT© (Hyprevention, Inc.) vertebral augmentation system for treating pathologic, traumatic, or osteoporotic vertebral compression fractures.

OBJECTIVE

To assess the safety and effectiveness of a polyether ether ketone polymer transpedicular vertebral system (V-STRUT) combined with polymethylmethacrylate for treating vertebral compression fractures.

STUDY

DESIGN

A retrospective study.

SETTINGS: Eleven clinical sites in the United States: interventional radiology, interventional pain, and spine surgery departments.

METHODS

Fifty-two consecutive patients (23 men and 29 women; median age 71.5 years [SD = 10.8]) underwent treatment for vertebral compression fracture with V-STRUT and polymethylmethacrylate. Each patient's clinical and radiologic results were collected at 3 different time points (Baseline [preintervention], one-month, and 6-month follow-ups) using magnetic resonance imaging, x-ray, or computed tomography at the physician's discretion. Patients missing either the one-month follow-up (n = 11) or 6-months follow-up (n = 19) were excluded from Visual Analog Scale (VAS) score analysis for that time point, but were included for overall procedural data and safety analysis. Follow-up data were collected for 41 patients at one-month follow-up and 33 patients at 6-months follow-up. Fracture etiologies were osteoporosis in 43 (83%) patients and malignancy in 9 (17%). Data recorded were: procedure duration; fractured vertebral levels; treated vertebral levels; Genant Classification, and/or Magerl Classification fracture gradings; anesthesia; quantity of bone cement; implant sizes; and adverse events, including serious events. Pain was assessed using the Visual Analog Scale.

RESULTS

The procedure was completed successfully in all patients. The mean procedure duration was 48 minutes (SD = 23.7). Asymptomatic bone cement leakage occurred in 7/52 patients (13.5%), remote level fractures occured in 2/52 (3.8%), and new adjacent level fractures occurred in 4/52 (7.7%) patients; 4/52 (7.0%) patients died prior to completing all study milestones. Across both osteoporotic and pathologic fracture groups, the mean baseline VAS score was 81 mm (SD = 18.5); one-month postoperative scores were 36 mm (SD = 32.2, P = 0.0.005) and 6-months postoperative scores were 18 mm (SD = 25.1, P = 0.005).

LIMITATIONS: Our study has limitations inherent in all retrospective studies. The study results are the authors' data collection and is subject to different forms of bias including selection and recall bias.

CONCLUSIONS

This study reflects clinical experience to date for the V-STRUT device in the United States. This initial data demonstrates the safety and early efficacy for treating osteoporotic and malignant thoracolumbar compression fractures associated with severe refractory pain.