The objective of this research was to determine the efficacy and safety of an experimental instrumentation device designed for transpedicular spinal fixation by evaluating fusion rates and clinical pain and function scores; to determine complication rates associated with the device; and to compare the obtained data with that previously published in the literature. Four hundred forty-two consecutive patients were enrolled in this 4-year, Food and Drug Administration-monitored investigational device exemption trial to undergo surgery for implantation of the device. Eighteen surgeons at 11 nationwide medical centers performed the operations and subsequent evaluations. The study population was derived from three diagnostic categories: degenerative disc disease, multioperated back, and vertebral fracture. The data source consisted of radiographs, clinical examination, and structured forms and questionnaires. Patients were evaluated preoperatively, intraoperatively, and postoperatively at 3, 6, 12, and 24 months. By the 24-month postoperative interval, attrition had reduced the study population to 342 patients, among whom bony fusion was obtained in 91.5%. Pain scores demonstrated a statistically significant improvement in clinical outcome. Intraoperative complications occurred in 21.9% of patients. Of the 442 study patients, 2.9% experienced device-related complications. Moreover, a total of 2,304 screws and bolts were implanted in this patient population. Of these, 0.39% were reported to have fractured. Among the 342 study patients observed during 24 months, the breakage rate of device components (bolt or screw) was 2.63%. These data compare favorably to existing reports of spinal arthrodesis effected with other types of instrumentation and without device implantation. In a 4-year trial, the experimental transpedicular fixation instrumentation produced successful spinal fusion in the majority of our study population, with acceptable complication rates.
- Clinical trial
- Investigational device exemption (IDE)
- Transpedicular fixation instrumentation
ASJC Scopus subject areas
- Clinical Neurology