Rationale of a Test Setup with a Defined COR for Extra-Discal Motion-Preserving Implants with a Low Implant Stiffness

Abstract

Abstract In the current version of ASTM F2624, the center of rotation (COR) is not specified. Potentially, each device can be tested using a different COR, which subsequently makes a direct design comparison of results difficult. Four posterior dynamic stabilization (PDS) devices (Dynesys, DYN, Zimmer; DSS, Paradigm Spine; and two Aesculap implant concepts) were tested in comparison to a rigid-fixation device and to the native situation of the lumbar spine on fresh-frozen human lumbar spines (L3–L5). The instrumented level was L4–L5. The PDS systems have axial compressive stiffness values ranging from 10 N/mm to 230 N/mm and were all made compatible to connect with the pedicle-screw system. The specimens were loaded in a spinal simulator, applying pure moments for flexion/extension, lateral bending and axial rotation (+/−7.5 Nm) with a defined velocity. The COR was analyzed based on the data measured with a 3-dimensional (3D) motion-analysis system. The effect of the PDS on the location of the COR is most pronounced in the sagittal plane. In general, the higher the implant stiffness, the more the COR shifted in a posterior direction. The DYN had a similar COR to the rigid fixator. However, the PDS systems with low axial compressive stiffness values (range: 10–70 N/mm) showed very similar results on CORs, which are located in the region of the posterior border of the intervertebral disc. In the frontal and transversal plane, the COR was found to be close to the native situation for each system. Therefore, for PDS devices with low implant stiffness, the location of the COR varies only marginally and can be specified for a test setup. An initial proposal that will allow side-by-side comparison for these kinds of PDS systems is given and the feasibility of the new test setup could be proven for all three loading conditions.