STUDY DESIGN: A biomechanical study to evaluate the effects of interspinous spacer under cyclic complex loading. OBJECTIVES: To determine the risk of device migration and to assess damage on the device and specimen under extreme coupled motion. Another objective was to evaluate the effect on vertebral foramen and canal dimensions after spacer implantation. SUMMARY OF BACKGROUND DATA: Interspinous spacers are a relatively new treatment option that are clinically exposed to complex loads. However, the biomechanical performance of these spacers has not been well characterized. METHODS: Six human cadaveric motion segments were used for this study. The interspinous spacer (SuperionTM, Vertiflex Inc, California) was tested for 5 degrees extension/10 degrees flexion coupled with an axial rotation of +/-3 degrees. CT images were taken for specimens in neutral, 5 degrees extension, and 10 degrees flexion before and after the implantation of the spacer. Vertebral foramen and canal dimensions were quantified. RESULTS: There was no device migration or subsidence. Specimens did not sustain any significant injury during testing. Canal area was minimally altered and foramen height, width, and area increased in extension and were statistically significant as compared to intact. CONCLUSION: Interspinous spacer effectively prevents the motion at the implanted level and does not change the anatomy significantly.
STUDY DESIGN: A biomechanical study to evaluate the effects of interspinous spacer under cyclic complex loading. OBJECTIVES: To determine the risk of device migration and to assess damage on the device and specimen under extreme coupled motion. Another objective was to evaluate the effect on vertebral foramen and canal dimensions after spacer implantation. SUMMARY OF BACKGROUND DATA: Interspinous spacers are a relatively new treatment option that are clinically exposed to complex loads. However, the biomechanical performance of these spacers has not been well characterized. METHODS: Six human cadaveric motion segments were used for this study. The interspinous spacer (SuperionTM, Vertiflex Inc, California) was tested for 5 degrees extension/10 degrees flexion coupled with an axial rotation of +/-3 degrees. CT images were taken for specimens in neutral, 5 degrees extension, and 10 degrees flexion before and after the implantation of the spacer. Vertebral foramen and canal dimensions were quantified. RESULTS: There was no device migration or subsidence. Specimens did not sustain any significant injury during testing. Canal area was minimally altered and foramen height, width, and area increased in extension and were statistically significant as compared to intact. CONCLUSION: Interspinous spacer effectively prevents the motion at the implanted level and does not change the anatomy significantly.
Authors: Timothy R Deer; Dawood Sayed; Mark N Malinowski; Jeffery J Rowe; Jessica B Jameson; Kevin Liang; Joseph A Sclafani Journal: Pain Med Date: 2019-12-01 Impact factor: 3.750