Cadaveric Study of the Safety and Device Functionality of Magnetically Controlled Growing Rods After Exposure to Magnetic Resonance Imaging
Publication Date
2018
Journal Title
Spine Deform
Abstract
© 2017 Scoliosis Research Society Study Design: Cadaveric study. Objective: To establish the safety and efficacy of magnetically controlled growing rods (MCGRs) after magnetic resonance imaging (MRI) exposure. Summary of Background Data: MCGRs are new and promising devices for the treatment of early-onset scoliosis (EOS). A significant percentage of EOS patients have concurrent spinal abnormalities that need to be monitored with MRI. There are major concerns of the MRI compatibility of MCGRs because of the reliance of the lengthening mechanism on strongly ferromagnetic actuators. Methods: Six fresh-frozen adult cadaveric torsos were used. After thawing, MRI was performed four times each: baseline, after implantation of T2–T3 thoracic rib hooks and L5–S1 pedicle screws, and twice after MCGR implantation. Dual MCGRs were implanted in varying configurations and connected at each end with cross connectors, creating a closed circuit to maximize MRI-induced heating. Temperature measurements and tissue biopsies were obtained to evaluate thermal injury. MCGRs were tested for changes to structural integrity and functionality. MRI images obtained before and after MCGR implantation were evaluated. Results: Average temperatures increased incrementally by 1.1°C, 1.3°C, and 0.5°C after each subsequent scan, consistent with control site temperature increases of 1.1°C, 0.8°C, and 0.4°C. Greatest cumulative temperature change of +3.6°C was observed adjacent to the right-sided actuator, which is below the 6°C threshold cited in literature for clinically detectable thermal injury. Histologic analysis revealed no signs of heat-induced injury. All MCGR actuators continued to function properly according to the manufacturer's specifications and maintained structural integrity. Significant imaging artifacts were observed, with the greatest amount when dual MCGRs were implanted in standard/offset configuration. Conclusions: We demonstrate minimal MRI-induced temperature change, no observable thermal tissue injury, preservation of MCGR-lengthening functionality, and no structural damage to MCGRs after multiple MRI scans. Expectedly, the ferromagnetic actuators produced substantial MR imaging artifacts. Level of Evidence: Level V.
Volume Number
6
Issue Number
3
Pages
290 - 298
Document Type
Article
Status
Faculty, Northwell Researcher
Facility
School of Medicine; Northwell Health
Primary Department
Orthopedic Surgery
Additional Departments
Molecular Medicine; Radiology; Urology
PMID
DOI
10.1016/j.jspd.2017.11.003