Preclinical Evaluation of a Novel 3D-Printed Movable Lumbar Vertebral Complex for Replacement: In Vivo and Biomechanical Evaluation of Goat Model

PURPOSE: This was an in vivo study to develop a novel movable lumbar artificial vertebral complex (MLVC) in a goat model. The purpose of this study was to evaluate clinical and biomechanical characteristics of MLVC and to provide preclinical data for a clinical trial in the future. METHODS: According to the preoperative X-ray and CT scan data of the lumbar vertebrae, 3D printing of a MLVC was designed and implanted in goats. The animals were randomly divided into three groups: intact, fusion, and nonfusion. In the intact group, only the lumbar vertebrae and intervertebral discs were exposed during surgery. Both the fusion and nonfusion groups underwent resection of the lumbar vertebral body and the adjacent intervertebral disc. Titanium cages and lateral plates were implanted in the fusion group. MLVC was implanted in the nonfusion group. All groups were evaluated by CT scan and micro-CT to observe the spinal fusion and tested using the mechanical tester at 6 months after operation. RESULTS: The imaging results showed that with the centrum, the artificial endplates of the titanium cage and MLVC formed compact bone trabeculae. In the in vitro biomechanical test, the average ROM of L3-4 and L4-5 for the nonfusion group was found to be similar to that of the intact group and significantly higher in comparison to that of the fusion group (P < 0.05). The average ROM of flexion, extension, lateral bending, and rotation in the L2-3 intervertebral space significantly increased in the fusion group compared with the intact group and the nonfusion group (P < 0.001). There were no significant differences in flexion, extension, lateral bending, and rotation between the nonfusion and intact groups (P > 0.05). The average ROM of flexion, extension, lateral bending, and rotation in the L2-5 intervertebral space was not significantly different between the intact group, the fusion group, and the nonfusion group, and there was no statistical significance (P > 0.05). HE staining results did not find any metal and polyethylene debris caused by abrasion. CONCLUSION: In vivo MLVC can not only reconstruct the height and stability of the centrum of the operative segment but also retain the movement of the corresponding segment.