Numerical evaluation of spinal reconstruction using a 3D printed vertebral body replacement implant: effects of material anisotropy.

Background and objective: Artificial vertebral implants have been widely used for functional reconstruction of vertebral defects caused by tumors or trauma. However, the evaluation of their biomechanical properties often neglects the influence of material anisotropy derived from the host bone and implant's microstructures. Hence, this study aims to investigate the effect of material anisotropy on the safety and stability of vertebral reconstruction. Material and methods: Two finite element models were developed to reflect the difference of material properties between linear elastic isotropy and nonlinear anisotropy. Their biomechanical evaluation was carried out under different load conditions including flexion, extension, lateral bending and axial rotation. These performances of two models with respect to safety and stability were analyzed and compared quantitatively based on the predicted von Mises stress, displacement and effective strain. Results: The maximum von Mises stress of each component in both models was lower than the yield strength of respective material, while the predicted results of nonlinear anisotropic model were generally below to those of the linear elastic isotropic model. Furthermore, the maximum von Mises stress of natural vertebra and reconstructed system was decreased by 2-37 MPa and 20-61 MPa, respectively. The maximum reductions for the translation displacement of the artificial vertebral body implant and motion range of whole model were reached to 0.26 mm and 0.77°. The percentage of effective strain elements on the superior and inferior endplates adjacent to implant was diminished by up to 19.7% and 23.1%, respectively. Conclusion: After comprehensive comparison, these results indicated that the finite element model with the assumption of linear elastic isotropy may underestimate the safety of the reconstruction system, while misdiagnose higher stability by overestimating the range of motion and bone growth capability.

Customed 3D-printed Polyetheretherketone (PEEK) Implant for Secondary Salvage Reconstruction of Mandibular Defects: Case Report and Literature Review.

Given the insufficient height of single-barrel fibula and inadequate bone volume of double-barrel vascularized fibula in mandibular reconstruction, it is a better choice to combine the upper full-thickness vascularized fibula with the lower half-thickness nonvascularized fibula. However, the nonvascularized fibula may fail due to complications, affecting the facial shape and occlusal function. Polyetheretherketone is a thermoplastic polymer used for bone defect reconstruction due to its good mechanical properties and biocompatibility. This case report mainly presents a secondary salvage reconstruction of the mandible by using customed 3-dimensional-printing polyetheretherketone, which restored the continuity and symmetry of the mandible, improved the patient's facial shape, and restored functional occlusion through dental implants. After a 28-month follow-up, no complications occurred, and the patient was satisfied with the final restoration.

Additive manufactured polyether-ether-ketone implants for orthopaedic applications: a narrative review.

Polyether-ether-ketone (PEEK) is believed to be the next-generation biomedical material for orthopaedic implants that may replace metal materials because of its good biocompatibility, appropriate mechanical properties and radiolucency. Currently, some PEEK implants have been used successfully for many years. However, there is no customised PEEK orthopaedic implant made by additive manufacturing licensed for the market, although clinical trials have been increasingly reported. In this review article, design criteria, including geometric matching, functional restoration, strength safety, early fixation, long-term stability and manufacturing capability, are summarised, focusing on the clinical requirements. An integrated framework of design and manufacturing processes to create customised PEEK implants is presented, and several typical clinical applications such as cranioplasty patches, rib prostheses, mandibular prostheses, scapula prostheses and femoral prostheses are described. The main technical challenge faced by PEEK orthopaedic implants lies in the poor bonding with bone and soft tissue due to its biological inertness, which may be solved by adding bioactive fillers and manufacturing porous architecture. The lack of technical standards is also one of the major factors preventing additive-manufactured customised PEEK orthopaedic implants from clinical translation, and it is good to see that the abundance of standards in the field of additive-manufactured medical devices is helping them enter the clinical market.

Effects of Raster Angle and Material Components on Mechanical Properties of Polyether-Ether-Ketone/Calcium Silicate Scaffolds.

Polyetheretherketone (PEEK) was widely used in the fabrication of bone substitutes for its excellent chemical resistance, thermal stability and mechanical properties that were similar to those of natural bone tissue. However, the biological inertness restricted the osseointegration with surrounding bone tissue. In this study, calcium silicate (CS) was introduced to improve the bioactivity of PEEK. The PEEK/CS composites scaffolds with CS contents in gradient were fabricated with different raster angles via fused filament fabrication (FFF). With the CS content ranging from 0 to 40% wt, the crystallinity degree (from 16% to 30%) and surface roughness (from 0.13 ± 0.04 to 0.48 ± 0.062 µm) of PEEK/CS scaffolds was enhanced. Mechanical testing showed that the compressive modulus of the PEEK/CS scaffolds could be tuned in the range of 23.3-541.5 MPa. Under the same printing raster angle, the compressive strength reached the maximum with CS content of 20% wt. The deformation process and failure modes could be adjusted by changing the raster angle. Furthermore, the mapping relationships among the modulus, strength, raster angle and CS content were derived, providing guidance for the selection of printing parameters and the control of mechanical properties.

Effects of printing path and material components on mechanical properties of 3D-printed polyether-ether-ketone/hydroxyapatite composites.

Polyether-ether-ketone (PEEK) exhibits excellent mechanical properties and biocompatibility. Three-dimensional (3D) printing of PEEK bone substitutes has been widely used in clinical application. However, the inertness of pure PEEK hinders its integration with the surrounding bone tissue. In this study, for the first time, PEEK/hydroxyapatite (HA) composite specimens were fabricated using fused filament fabrication (FFF) technology. PEEK/HA filaments with HA contents of 0-30 wt% were fabricated via mechanical mixing and extrusion. The HA distributions inside the composite matrix and the surface morphology characteristics of the PEEK/HA composites were examined. The effects of the printing path and HA content on the mechanics of the PEEK/HA composites were systematically investigated. The results indicated that the HA particles were uniformly distributed on the composite matrix. With an increase in the HA content, the modulus of the PEEK/HA composite increased, while the strength and failure strain concomitantly decreased. When the HA content increased to 30 wt%, the tensile modulus of the composite increased by 68.6% compared with that of pure PEEK printed along the horizontal 90° path, while the tensile strength decreased by 48.2% compared with that of pure PEEK printed along the vertical 90° path. The fracture elongation of the printed specimens with different HA contents decreased in the following order: horizontal 0° > horizontal 90° > vertical 90°. The best comprehensive mechanical properties were achieved for pure PEEK fabricated along the horizontal 0° path. The results indicate that FFF technology is applicable for additive manufacturing of PEEK/HA composites with controllable compositions. Printed PEEK/HA composites have potential for applications in the design and manufacturing of personalized bone substitutes.

3D-printed PEEK implant for mandibular defects repair - a new method.

Functional reconstruction of large-size mandibular continuity defect is still a major challenge in the oral and maxillofacial surgery due to the unsatisfactory repair effects and various complications. This study aimed to develop a new functional repair method for mandibular defects combined with 3D-printed polyetheretherketone (PEEK) implant and the free vascularized fibula graft, and evaluated the service performance of the implant under whole masticatory motion. The design criteria and workflows of the mandibular reconstruction were established based on the requirements of safety, functionality, and shape consistency. Both the biomechanical behavior and the mechanobiological property of mandibular reconstruction under various masticatory motion were investigated by the finite element analysis. The maximum von Mises stress of each component was lower than the yield strength of the corresponding material and the safety factor was more than 2.3 times, which indicated the security of the repair method can be guaranteed. Moreover, the actual deformation of the reconstruction model was lower than that of the normal mandible under most clenching tasks, which assured the primary stability. More than 80% of the volume elements in the bone graft can obtain effective mechanical stimulation, which benefited to reduce the risks of bone resorption. Finally, the novel repair method was applied in clinic and good clinical performances have been achieved. Compared with the conventional fibular bone graft for surgical mandibular reconstruction, this study provides excellent safety and stability to accomplish the functional reconstruction and aesthetic restoration of the mandible defect.

Biomechanical characterization of vertebral body replacement in situ: Effects of different fixation strategies.

BACKGROUND AND OBJECTIVE: Artificial vertebral implant with a lateral or posterior screw-rod fixation system are usually employed in lumbar reconstruction surgery to rebuild the lumbar spine after partial resection due to a tumor or trauma. However, few studies have investigated the effect of the various fixation systems on the biomechanics of the reconstructed lumbar system. This study aims to evaluate the influence of different surgical fixation strategies on the biomechanical performance of a reconstructed lumbar spine system in terms of the strength and long-term stability. METHODS: Two typical lumbar spine reconstruction case models that correspond to lateral or posterior fixation systems were built based on the clinical data. Finite element analyses were performed, and comparisons were made between the two models based on the predicted stress distribution of the reconstructed lumbar spine model, bone-growth area of the endplate, and the range of motion under various normal daily activities. RESULTS: The load from the upper vertebral body was found to be effectively transmitted onto the lower vertebral body by a vertebral implant with the lateral fixation system; this was favorable for bone growth after surgery. However, significantly high stresses were concentrated around the interaction region between the screws and bone, owing to the uneven lateral fixation structure; this may increase the risk of bone fractures and screw loosening in the long term. For the posterior fixation case, stably posterior fixation structure was favorable to maintain stability for the reconstructed lumbar spine. However, the load was mainly transmitted via the fixation rod rather than the vertebral implant, owing to the stress shielding effect. Therefore, the predicted strain on the endplate were insufficient for bone ingrowth under most of the spinal activates, which could cause bone loss and prosthesis loosening. CONCLUSIONS: In this study, the comparisons of the reconstructed lumbar spine system with lateral and posterior fixation strategies were conducted. The Pros and Cons of these two fixation strategies was deeply discussed and the associated clinical issues were provided. The results of this study will have a clear impact in understanding the biomechanics of the lumbar spine with different fixation strategies and providing necessary instructions to the design and application of the lumbar spinal fixation system.

Bionic design and verification of 3D printed PEEK costal cartilage prosthesis.

Chest wall reconstructions are mainly needed after surgical treatment of tumors or trauma. The costal cartilage is part of the chest wall, connecting sternum and ribs. The currently existing rib prostheses made of Titanium or PEEK were found lacking the costal cartilage portion, causing unsatisfactory functional rehabilitation of breath. This study proposed a newly bionic methodology for designing a costal cartilage prosthesis using a wavy elastic structure. By changing the design parameters, the mechanical properties can be accurately adjusted. Finite element analysis was carried out for the optimization of the prostheses. Then the prostheses were fabricated by fused deposition modelling manufacturing technology, using PEEK. Mechanical tests were carried out to determine the elastic modulus of the prostheses. The equivalent modulus ranged 0.5-17.3 MPa, and the tensile strength ranged 0.7-8.3 MPa. The results indicated that the mechanical behavior of the designed prostheses were close to those of the natural costal cartilage and that the wavy elastic structure was a reasonable choice for designing a costal cartilage prosthesis. Therefore, the designed PEEK costal cartilage prostheses have the potential as replacement of the natural costal cartilage with better breathing function for the patient undergoing chest wall reconstruction.

Custom design and biomechanical analysis of 3D-printed PEEK rib prostheses.

A tumour resection normally involves a large tissue resection and bone replacement. Polyether ether ketone (PEEK) has become a suitable candidate for use in various prostheses owing to its lightness in weight, modulus close to that of natural bone, and good biocompatibility, among other factors. This study proposes a new design method for a rib prosthesis using the centroid trajectory of the natural replaced rib, where the strength can be adjusted by monitoring the cross-sectional area, shape, and properties. A custom-designed rib prosthesis was manufactured using fused deposition modelling (FDM) manufacturing technology, and the mechanical behaviour was found to be close to that of a natural rib. A finite element analysis of the designed rib was carried out under similar loading conditions to those used in mechanical testing. The results indicate that the centroid trajectory derived from a natural rib diaphysis can provide reliable guidance for the design of a rib prosthesis. Such methodology not only offers considerable design freedom in terms of shape and required strength, but also benefits the quality of the surface finishing for samples manufactured using the FDM technique. FDM-printed PEEK rib prostheses have been successfully implanted, and good clinical performances have been achieved.