This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.
PRIMARY OBJECTIVE: I. To document the safety of utilizing MRI compatible hardware for intraoperative MRI-based image guidance to perform percutaneous spinal procedures. SECONDARY OBJECTIVE: I. To determine the accuracy of the MRI-based image guidance. OUTLINE: Patients undergo standard of care spine surgery with MRI-based image guidance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
16
Undergo MRI-guided surgery
Undergo spinal surgery
M D Anderson Cancer Center
Houston, Texas, United States
Incidence of intraoperative adverse events
Safety will be assessed as a dichotomous variable. Frequencies and descriptive statistics of the outcomes under study will be performed. 95% confidence intervals will be computed. Other ad-hoc analyses may be performed as well.
Time frame: During surgery
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