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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v18.i4.30
pages 289-302

Cyclic Loads Do Not Compromise Functionality of the Interspinous Spacer or Cause Damage to the Spinal Segment: An In Vitro Analysis

Amanesh Goyal
Engineering Center for Orthopaedic Research Excellence (E-CORE), Departments of Bioengineering and Orthopaedic Surgery, Colleges of Engineering and Medicine, University of Toledo, Toledo, Ohio
Vijay K. Goel
Engineering Center for Orthopaedic Research Excellence (E-CORE), Departments of Bioengineering and Orthopaedic Surgery, Colleges of Engineering and Medicine, University of Toledo, Toledo, Ohio
Ankit Mehta
Engineering Center for Orthopaedic Research Excellence (E-CORE), Departments of Bioengineering and Orthopaedic Surgery, Colleges of Engineering and Medicine, University of Toledo, Toledo, Ohio
David Dick
Engineering Center for Orthopaedic Research Excellence (E-CORE), Departments of Bioengineering and Orthopaedic Surgery, Colleges of Engineering and Medicine, University of Toledo, Toledo, Ohio
Suresh Reddy Chinthakunta
Engineering Center for Orthopaedic Research Excellence (E-CORE), Departments of Bioengineering and Orthopaedic Surgery, Colleges of Engineering and Medicine, University of Toledo, Toledo, Ohio
Lisa Ferrara
OrthoKinetic Technologies, LLC, Southport, North Carolina

ABSTRACT

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° extension/10° flexion coupled with an axial rotation of ±3°. CT images were taken for specimens in neutral, 5° extension, and 10° 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.