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




            environment for bone ingrowth after surgery. Both FE analysis and biomechanical fatigue tests confirmed that OWS
            mechanical performance with lattice design was more stable than the HTO TP fixations.


            Keywords: 3D printing; Topology optimization; Lattice; Finite element; High tibial osteotomy


            1. Introduction                                    interface can effectively enhance bone ingrowth collectively
                                                               represent another issue of  concern. Therefore,  the WS
            Structural topology optimization and titanium alloy three-  structural design is required to provide enough strength
            dimensional  (3D)  printing  technology  combination  has   to withstand the stresses on the tibia, while also ensuring
            been widely proposed for medical implant manufacturing.   stability when fixed to the remaining tibia. Additionally,
            This approach effectively improves the implant structural   the bone contact surface should have the ability to promote
            strength and weight, but also takes advantage of metal 3D   bone ingrowth.
            printing process capabilities  to create complex  features
            for clinically unmet needs.  Another advantage of metal   This study used the WS design concept with embedded
                                 1-4
            3D printing applied to medical implants is the capability   screws to provide enough mechanical strength with
            to create various microbionic scaffolds (lattice structures).   structural optimization at the osteotomy site, using
            It has been documented that lattice structures with pore   the titanium  alloy 3D printing technique with bionic
            sizes around 600 µm and a porosity of approximately 70%   lattice design to provide a bone ingrowth environment.
            have been proven to effectively promote bone ingrowth.    The topology optimization analysis was integrated to
                                                         4-8
            Opening wedge high tibial osteotomy (HTO) is a well-  solve the stress-shielding effect problem by reducing the
            established surgical approach for varus gonarthrosis in   titanium spacer stiffness to obtain the optimal structure. A
            the young, active patients. The most notable advantages of   biomimetic microstructure lattice was filled into the hollow
            HTO include intraoperative angular correction precision,   part of the titanium spacer to increase the bone ingrowth
            maintaining bone stock, and avoiding fibula osteotomy,   capability after HTO surgery. Subsequent finite element
            which may compromise the peroneal nerve. 9-11  The long/  (FE) analysis was performed to compare the titanium
            rigid T-shaped titanium fixation bone plate often used   WS fixation system mechanical response against the
            with synthetic bone as a bone filler in the wedge-shaped   traditional T-shaped plate (TP) system under physiological
            osteotomy space to strengthen the whole structure is the   load conditions. The titanium WS with lattice design was
            most current treatment to maintain initial stability and   then fabricated via 3D printing technique to evaluate HTO
            correction angle after surgery. However, studies have   surgery fixation stability using  this  3D-printed titanium
            pointed out that the metabolic absorption of artificial   WS and traditional TP in the artificial bone osteotomy
            synthetic bone may reduce mechanical strength and limit   model through in vitro biomechanical fatigue testing.
            osteotomy space, and might be accompanied by a lateral
            tibial cortical bone fracture (lateral hinge fracture, LHF).   2. Materials and methods
            This increases the risk for bone plate fatigue fracture   2.1. Design of wedge-shaped spacer for osteotomy
                                   12
            and loss of correction angle.  The stress-shielding effect   tibia
            caused by the highly-rigid metal plate also delayed medial   This study collected the tibia from a 66-year-old
            cortical bone union and the time for patients to fully   female weighing 68 kg for computed tomography (CT)
            bear weight after surgery. 12-16 A new polyetheretherketone   scanning and image reconstruction, in adherence to a
            (PEEK) implant is developed with embedded screws that   protocol approved by the Taipei Medical University Joint
            can be inserted into the osteotomy gap in a uniplanar and   Institutional Review Board (TMU-JIRB) (Approval No.:
            closed-wedge-like technique with immediate close contact   N202006034). An FE model of the HTO was constructed
            between the PEEK material and proximal and distal cortical   to investigate its mechanics. The CT images were
            and spongious bone surface.  However, the PEEK material   reconstructed from clinical DICOM image files into a
                                  17
            surface properties are not conducive to cell ingrowth and   3D surface model using reverse engineering software
            cannot provide accelerated bone fusion at the osteotomy   (Mimics 22.0, Materialise NV, Leuven, Belgium). The
            site, easily producing long-term failure.          surface was then smoothed and the model imported
                                           9
               Although a titanium alloy wedge-shaped spacer (WS)   into computer-aided engineering (CAD) design software
            embedded with screws may provide enough mechanical   (SpaceClaim, SpaceClaim Corporation, Concord,
            strength, the stress-shielding effect caused by the high   Massachusetts, USA) to create the osteotomy tibia. Based
            strength titanium alloy and whether the metal–bone   on the recommended osteotomy for HTO according to


            Volume 10 Issue 1 (2024)                       493                          https://doi.org/10.36922/ijb.1584
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