Finite element analysis of patient-specific additive-manufactured implants.

Introduction: Bone tumors, characterized by diverse locations and shapes, often necessitate surgical excision followed by custom implant placement to facilitate targeted bone reconstruction. Leveraging additive manufacturing, patient-specific implants can be precisely tailored with complex geometries and desired stiffness, enhancing their suitability for bone ingrowth. Methods: In this work, a finite element model is employed to assess patient-specific lattice implants in femur bones. Our model is validated using experimental data obtained from an animal study (n = 9). Results: The results demonstrate the accuracy of the proposed finite element model in predicting the implant mechanical behavior. The model was used to investigate the influence of reducing the elastic modulus of a solid Ti6Al4V implant by tenfold, revealing that such a reduction had no significant impact on bone behavior under maximum compression and torsion loading. This finding suggests a potential avenue for reducing the endoprosthesis modulus without compromising bone integrity. Discussion: Our research suggests that employing fully lattice implants not only facilitates bone ingrowth but also has the potential to reduce overall implant stiffness. This reduction is crucial in preventing significant bone remodeling associated with stress shielding, a challenge often associated with the high stiffness of fully solid implants. The study highlights the mechanical benefits of utilizing lattice structures in implant design for enhanced patient outcomes.

Reducing the prosthesis modulus by inclusion of an open space lattice improves osteogenic response in a sheep model of extraarticular defect.

Introduction: Stress shielding is a common complication following endoprosthetic reconstruction surgery. The resulting periprosthetic osteopenia often manifests as catastrophic fractures and can significantly limit future treatment options. It has been long known that bone plates with lower elastic moduli are key to reducing the risk of stress shielding in orthopedics. Inclusion of open space lattices in metal endoprostheses is believed to reduce the prosthesis modulus potentially improving stress shielding. However, no in vivo data is currently available to support this assumption in long bone reconstruction. This manuscript aims to address this hypothesis using a sheep model of extraarticular bone defect. Methods: Initially, CT was used to create a virtual resection plan of the distal femoral metaphyses and to custom design endoprostheses specific to each femur. The endoprostheses comprised additively manufactured Ti6Al4V-ELI modules that either had a solid core with a modulus of ∼120 GPa (solid implant group) or an open space lattice core with unit cells that had a modulus of 3-6 GPa (lattice implant group). Osteotomies were performed using computer-assisted navigation followed by implantations. The periprosthetic, interfacial and interstitial regions of interest were evaluated by a combination of micro-CT, back-scattered scanning electron microscopy (BSEM), as well as epifluorescence and brightfield microscopy. Results: In the periprosthetic region, mean pixel intensity (a proxy for tissue mineral density in BSEM) in the caudal cortex was found to be higher in the lattice implant group. This was complemented by BSEM derived porosity being lower in the lattice implant group in both caudal and cranial cortices. In the interfacial and interstitial regions, most pronounced differences were observed in the axial interfacial perimeter where the solid implant group had greater bone coverage. In contrast, the lattice group had a greater coverage in the cranial interfacial region. Conclusion: Our findings suggest that reducing the prosthesis modulus by inclusion of an open-space lattice in its design has a positive effect on bone material and morphological parameters particularly within the periprosthetic regions. Improved mechanics appears to also have a measurable effect on the interfacial osteogenic response and osteointegration.

Robot-assisted implantation of additively manufactured patient-specific orthopaedic implants: evaluation in a sheep model.

PURPOSE: Bone tumours must be surgically excised in one piece with a margin of healthy tissue. The unique nature of each bone tumour case is well suited to the use of patient-specific implants, with additive manufacturing allowing production of highly complex geometries. This work represents the first assessment of the combination of surgical robotics and patient-specific additively manufactured implants. METHODS: The development and evaluation of a robotic system for bone tumour excision, capable of milling complex osteotomy paths, is described. The developed system was evaluated as part of an animal trial on 24 adult male sheep, in which robotic bone excision of the distal femur was followed by placement of patient-specific implants with operative time evaluated. Assessment of implant placement accuracy was completed based on post-operative CT scans. RESULTS: A mean overall implant position error of 1.05 ± 0.53 mm was achieved, in combination with a mean orientation error of 2.38 ± 0.98°. A mean procedure time (from access to implantation, excluding opening and closing) of 89.3 ± 25.25 min was observed, with recorded surgical time between 58 and 133 min, with this approximately evenly divided between robotic (43.9 ± 15.32) and implant-based (45.4 ± 18.97) tasks. CONCLUSIONS: This work demonstrates the ability for robotics to achieve repeatable and precise removal of complex bone volumes of the type that would allow en bloc removal of a bone tumour. These robotically created volumes can be precisely filled with additively manufactured patient-specific implants, with minimal gap between cut surface and implant interface.

Influence of therapeutic grip exercises induced loading rates in distal radius fracture healing with volar locking plate fixation.

BACKGROUND AND OBJECTIVE: Therapeutic exercises could potentially enhance the healing of distal radius fractures (DRFs) treated with volar locking plate (VLP). However, the healing outcomes are highly dependant on the patient-specific fracture geometries (e.g., gap size) and the loading conditions at the fracture site (e.g., loading frequency) resulted from different types of therapeutic exercises. The purpose of this study is to investigate the effects of different loading frequencies induced by therapeutic exercises on the biomechanical microenvironment of the fracture site and the transport of cells and growth factors within the fracture callus, ultimately the healing outcomes. This is achieved through numerical modelling and mechanical testing. METHODS: Five radius sawbones specimens (Pacific Research Laboratories, Vashon, USA) fixed with VLP (VRP2.0+, Austofix) were mechanically tested using dynamic test instrument (INSTRON E3000, Norwood, MA). The loading protocol used in mechanical testing involved a series of cyclic axial compression tests representing hand and finger therapeutic exercises. The relationship between the dynamic loading rate (i.e., loading frequency) and dynamic stiffness of the construct was established and used as inputs to a developed numerical model for studying the dynamic loading induced cells and growth factors in fracture site and biomechanical stimuli required for healing. RESULTS: There is a strong positive linear relationship between the loading rate and axial stiffness of the construct fixed with VLP. The loading rates induced by the moderate frequencies (i.e., 1-2 Hz) could promote endochondral ossification, whereas relatively high loading frequencies (i.e., over 3 Hz) may hinder the healing outcomes or lead to non-union. In addition, a dynamic loading frequency of 2 Hz in combination of a fracture gap size of 3 mm could produce a better healing outcome by enhancing the transport of cells and growth factors at the fracture site in comparison to free diffusion (i.e. without loading), and thereby produces a biomechanical microenvironment which is favourable for healing. CONCLUSION: The experimentally validated numerical model presented in this study could potentially contribute to the design of effective patient-specific therapeutic exercises for better healing outcomes. Importantly, the model results demonstrate that therapeutic grip exercises induced dynamic loading could produce a better biomechanical microenvironment for healing without compromising the mechanical stability of the overall volar locking plate fixation construct.

Balance Between Mechanical Stability and Mechano-Biology of Fracture Healing Under Volar Locking Plate.

The application of volar locking plate (VLP) is promising in the treatment of dorsally comminuted and displaced fracture. However, the optimal balance between the mechanical stability of VLP and the mechanobiology at the fracture site is still unclear. The purpose of this study is to develop numerical models in conjunction with experimental studies to identify the favourable mechanical microenvironment for indirect healing, by optimizing VLP configuration and post-operative loadings for different fracture geometries. The simulation results show that the mechanical behaviour of VLP is mainly governed by the axial compression. In addition, the model shows that, under relatively large gap size (i.e., 3-5 mm), the increase of FWL could enhance chondrocyte differentiation while a large BPD could compromise the mechanical stability of VLP. Importantly, bending moment produced by wrist flexion/extension and torsion moment produced from forearm rotation could potentially hinder endochondral ossification at early stage of healing. The developed model could potentially assist orthopaedic surgeons in surgical pre-planning and designing post-operation physical therapy for treatment of distal radius fractures.

Image-Based Geometrical Characterization of Nodes in Additively Manufactured Lattice Structures.

Additive manufacturing (AM) enables the fabrication of lattice structures with optimal mechanical, fluid, and thermal properties. However, during the AM fabrication process, defects are produced in the strut and node elements, which comprise the lattice structure. This leads to discrepancies between the AM fabricated lattice and its idealized computer-aided design (CAD) model, negatively affecting the ability to predict the mechanical behavior of the fabricated lattice via numerical models. Current research is focused on quantification of geometric uncertainties in the strut elements of the lattice; as-manufactured node geometries remain relatively unexplored on an individual scale, despite their criticality to the mechanical response of the structure. Understanding the geometrical properties of as-manufactured nodes relative to CAD idealizations can be used to improve lattice designs and numerical models. In this research, X-ray microcomputed tomography (µCT) is used to analyze and quantify the as-manufactured nodal geometry, found in face-centered cubic and face-centered cubic with axial struts lattices fabricated via selective laser melting. A custom tool is developed that enables auto-isolation and classification of nodal joints from µCT-derived cross-sectional slices. Geometrical properties are extracted from the isolated nodal cross sections and compared with their idealized CAD model counterpart. Quantification of geometrical defects provides insight into how nodes within an AM lattice structure differ from each other and their idealized design. Overall, this research is an initial step toward developing accurate and efficient numerical models, as well as better node design for AM.