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International Journal of Bioprinting                                3D-printed oblique lumbar interbody cage



            studies report that 3D printing techniques have great   5. Conclusion
            potential to solve the problems of creating a porous   A new OLIF cage with embedded fixation screws was
            (lattice) surface coating on dense titanium and a porous   designed by integrating the FE and WTO analysis
            titanium  body [10-12,27,28] .  Therefore,  this  study  utilized   based on statistical results of endplate morphology. The
            metal 3D printing to manufacture our OLIF cage to   simulated results showed that the embedded screw fixation
            perform functional tests. Our 3D printer laboratory was   can improve the stability of the OLIF cage and decrease
            approved by the ISO13485 quality management system   endplate damage. The OLIF cage with lattice manufactured
            (Certificate Number: 1760.190828) to ensure that the   via metal 3D printing was subject to mechanical testing,
            implants meet the necessary regulations and to ensure   and we found that the dynamic axial compression and
            safety and quality.
                                                               compressive-shear tests exceeded FDA-recommended
               The stiffness measured under axial load was 16,658 N/  values by about two times. However, the edge design of the
            mm, and the endurance limit after 5 million dynamic tests   OLIF cage must undergo further improvements to increase
            was 6000 N [26,29,30] . These values were more than double the   resistance against dynamic strength.
            minimum battery of performance testing necessary for
            stiffness at 7690 N/mm and endurance limit at 3000 N as   Acknowledgments
            recommended by the FDA. However, it was prone to cracks
            at edge of the cage under 6000 N of cyclic force, suggesting   Authors would like to thank Microware Precision Co., Ltd,
            that the cage had insufficient support strength at the edge.   Taiwan for their assistance in cage and screw manufacture.
            It may be necessary to increase the edge wall thickness   Funding
            of the cage to enhance strength and maintain tissue
            permeability and bone growth range. Post-processing can   This study is supported in part by MOST project 109-2622-
            also  be considered to improve the  lack of toughness in   B-010-005 and 110-2221-E-075-004, Taiwan.
            metal 3D printing.
                                                               Conflict of interest
               The OLIF cage was not deformed, damaged, or
            cracked when the testing force reached the upper limit   The authors declare no conflicts of interest.
            of the machine capability of 24,000 N during the static
            compressive-shear test. Therefore, this value (24,000 N)   Author contributions
            was denoted as the ultimate compressive-shear strength.   Conceptualization: Po-Liang Lai, Chun-Li Lin
            This was higher than 95% of the vertebral cage strength   Investigation: Shao-Fu Huang, Hsuan-Wen Wang, Pei-
            values reported in the literature [26,29,30] . The corresponding   Hsin Liu
            stiffness can also be obtained as 19,643 N/mm, which is   Methodology: Shao-Fu Huang, Hsuan-Wen Wang, Pei-
            more than 8.85 times the FDA-recommended value of     Hsin Liu
            2219  N/mm. For the shear fatigue test, the OLIF cage   Resources: Po-Liang Lai, Chun-Li Lin
            was prone to damage on the anterior edge during the   Writing – original draft: Po-Liang Lai
            dynamic high-strength fatigue compression-shear test   Writing – review & editing: Chun-Li Lin
            above 3500 N. This phenomenon was consistent with the
            results of the aforementioned dynamic axial compressive   Ethics approval and consent to participate
            test, implying that the cage edge thickness may need to
            be improved. The endurance limit was at 2600 N for the   Not applicable.
            compressive-shear dynamic test, which is double the FDA-
            recommended limit of 1225 N .                      Consent for publication
                                    [26]
               The embedded screws were not considered during   Not applicable.
            the  compression/compressive-shear  tests,  which were
            conducted in accordance with the ASTM 2077 regulations   Availability of data
            recommended by the FDA . The results of this test are   Not applicable.
                                  [26]
            comparable  to  the  recommended  minimum  battery
            performance  of  the  benchmark  under  the  same  testing   References
            conditions. Nevertheless, it may be necessary to perform
            in vivo animal experiments in the future to evaluate the   1.   Orita S, Inage K, Furuya T,  et al., 2017, Oblique lateral
            fixation ability of embedded bone screws and the bone   interbody fusion (OLIF): Indications and techniques. Oper
            growth ability within cage lattices.                  Tech Orthop, 27(4): 223–230.



            Volume 9 Issue 5 (2023)                        456                         https://doi.org/10.18063/ijb.772
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