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International Journal of Bioprinting                          Macro and micro structure of a 3D-printed implant




            structure that experiences higher stress. The anterior part   bone damage.  Conversely, the maximum bone stress was
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            of the implant originally was a non-load-bearing region   158.8 MPa when TP implants were used, approximately
            designed with a cavity/channel/hole. However, the fixation   2.0 times the yield strength, clearly indicating bone
            screws needed to be positioned on the anterior side for   fracture.
            surgical consideration. Therefore, the WS presented a   This improvement can be attributed to the direct
            crescent section-section with solid part at the anterior side   support provided by the OWS system to the tibia osteotomy
            and hollow part at the posterior side.
                                                               surface, whereas the commercial TP plate system lacked
               The lattice filled within the wedge-shaped spacer was   such direct support. The OWS system offered a larger
            YM type, arranged in a 30% deformation pattern. YM is a   support area for compression, with a cross-sectional area
            newly designed lattice structure characterized by a spherical   approximately 8 times larger than that of the TP plate. Under
            shape with multiple corners to facilitate cell clustering.  The   identical load conditions, stress was inversely proportional
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            internal structure of the YM lattice maintains a 3D space,   to the supporting area. Consequently, the OWS system
            enabling the transportation of fluids and nutrients and the   effectively dispersed the stress concentration and reduced
            removal of impurities through interconnected through-  stress values in the lateral cortical bone by providing a
            holes, thereby promoting bone cell growth. The YM lattice   larger supporting area. In addition, stress shielding is
            with 30% deformation pattern, with a porosity rate of 65%   generally caused by the high implant stiffness, leading to
            and hole sizes ranging from approximately 600 to 900 µm,   bone strain less than the minimum strain-inducing bone
            was approved for  in  vivo animal experiments to offer an   resorption. 34,35  Therefore, we also recorded the maximum
            appropriate environment for bone ingrowth, facilitating the   tibia von Mises strain for OWS and TP models, and the
            testing of interfacial bond strength in surface porous designs   corresponding bone strain values were 3289 microstrain
            for 3D-printed medical implants. It is worth noting that   and  9185  microstrain  at  the  lateral  safe  zone  for  both.
            alternative lattice designs suitable for bone growth can also be   This finding indicated again that OWS model strain
            considered for filling the wedge-shaped spacer hollow region.  value falls into a reasonable bone remodeling stage due to
                                                               microstrain of less than 4000, which was an overloading
               The OWS system involved securing commercial bone             34,35
            screws onto the tibia, and for the effective locking test   threshold value.  The biomechanical fatigue test aimed
                                                               to simulate the gradual full weight-bearing tibia condition
            between the commercial bone screws and the 3D-printed   after  HTO,  using  a  commercially  available  TP  plate
            implant, high requirement for the roundness and OWS   system as the control group to investigate and validate the
            screw thread and hole accuracy was necessary. These   developed OWS system mechanical performance. The test
            factors impacted the fit of the embedded screws. This   also served to correlate with the results obtained from FE
            was also why the manufacturing accuracy requirement   analysis. A medial-lateral displacement difference on the
            was set within 1% in this study. Adjustments in 3D metal   tibial plateau exceeding 2 mm was set as the failure criteria
            printing parameters and limitations on adjustment ranges   because as early as 1988, Ertl et al. studied 15 patients who
            were  necessary  to  achieve  optimal  locking  performance.   underwent a triplane fracture and whose fracture anatomy
            This involved scaling and evaluating the true screw hole   could be confirmed in X-ray images.  They found that
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            dimension values to find the best locking effect and   only 8 of 15 patients were asymptomatic after the fracture
            processing conditions.
                                                               in an evaluation spanning from 38 months to 13 years. The
               The primary failure risk in HTO surgery is lateral   result pointed out that postoperative residual displacement
            cortical bone fracture. FE analysis results indicated   exceeding 2 mm (the medial-lateral displacement
            that using a commercial TP plate system leads to stress   difference on the tibial plateau) was associated with
            concentration in the central bone plate area and the   adverse symptoms. Rapariz et al. reviewed 35 patients who
            lateral cortical bone cut edge. Conversely, OWS system   underwent surgery for distal tibia triplane fractures.  It was
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            implementation  effectively  distributed  the  overall  load,   also noted that degenerative changes are seen in long-term
            resulting in reduced stress concentration at the lateral   (>5 years) observation when adequate reduction has not
            cortical bone cut edge. The maximum first principal   been achieved postoperatively (<2 mm displacement).
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            stress values in the bone demonstrated a decreasing trend   Therefore, when the postoperative difference between
            with the OWS system compared to the TP plate system,   medial and  lateral  tibial displacement  is  greater  than 2
            significantly mitigating stress concentration in the lateral   mm, it is clinically judged as a risk factor. The setting is
            cortical bone. The corresponding maximum bone stress   considered  failure  (destruction)  and  is  also  widely  used
            value was reduced to 56.7 MPa, well below the cortical   in HTO research. For example, Pape et al. performed a
            bone yield strength in the elderly population, which is   mechanical study on human cadaver bones after high tibial
            approximately 80 MPa,  as the criterion for assessing   osteotomy,  and Diffo Kaze et al. performed a mechanical
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            Volume 10 Issue 1 (2024)                       503                          https://doi.org/10.36922/ijb.1584
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