Osteointegration of Ti Bone Implants: A Study on How Surface Parameters Control the Foreign Body Response.

The integration of titanium (Ti)-based implants with bone is limited, resulting in implant failure. This lack of osteointegration is due to the foreign body response (FBR) that occurs after the implantation of biodevices. The process begins with protein adsorption, which is governed by implant surface properties, e.g., chemistry, charge, wettability, and/or topography. The distribution and composition of the protein layer in turn influence the recruitment, differentiation, and modulation of immune and bone cells. The subsequent events that occur at the bone-material interface will ultimately determine whether the implant is encapsulated or will integrate with bone. Despite the numerous studies evaluating the influence of surface properties in the various stages of the FBR, the factors that affect tissue-material interactions are often studied in isolation or in small correlations due to the technical challenges involved in assessing them in vitro or in vivo. Consequently, the influence of protein conformation on the Ti bone implant surface design remains an unresolved research question. The objective of this review is to comprehensively evaluate the existing literature on the effect of surface parameters of Ti and its alloys in the stages of FBR, with a particular focus on protein adsorption and osteoimmunomodulation. This evaluation aims to systematically describe these effects on bone formation.

Mesoscale characterization of osseointegration around an additively manufactured genistein-coated implant.

Given the hierarchical nature of bone and bone interfaces, osseointegration, namely the formation of a direct bone-implant contact, is best evaluated using a multiscale approach. However, a trade-off exists between field of view and spatial resolution, making it challenging to image large volumes with high resolution. In this study, we combine established electron microscopy techniques to probe bone-implant interfaces at the microscale and nanoscale with plasma focused ion beam-scanning electron microscopy (PFIB-SEM) tomography to evaluate osseointegration at the mesoscale. This characterization workflow is demonstrated for bone response to an additively manufactured Ti-6Al-4V implant which combines engineered porosity to facilitate bone ingrowth and surface functionalization via genistein, a phytoestrogen, to counteract bone loss in osteoporosis. SEM demonstrated new bone formation at the implant site, including in the internal implant pores. At the nanoscale, scanning transmission electron microscopy and energy-dispersive X-ray spectroscopy confirmed the gradual nature of the bone-implant interface. By leveraging mesoscale analysis with PFIB-SEM tomography that captures large volumes of bone-implant interface with nearly nanoscale resolution, the presence of mineral ellipsoids varying in size and orientation was revealed. In addition, a well-developed lacuno-canalicular network and mineralization fronts directed both towards the implant and away from it were highlighted.

Interfaces between Cranial Bone and AISI 304 Steel after Long-Term Implantation: A Case Study of Cranial Screws.

Interfaces between AISI 304 stainless steel screws and cranial bone were investigated after long-term implantation lasting for 42 years. Samples containing the interface regions were analyzed using state-of-the-art analytical techniques including secondary ion mass, Fourier-transform infrared, Raman, and X-ray photoelectron spectroscopies. Local samples for scanning transmission electron microscopy were cut from the interface regions using the focused ion beam technique. A chemical composition across the interface was recorded in length scales covering micrometric and nanometric resolutions and relevant differences were found between peri-implant and the distant cranial bone, indicating generally younger bone tissue in the peri-implant area. Furthermore, the energy dispersive spectroscopy revealed an 80 nm thick steel surface layer enriched by oxygen suggesting that the AISI 304 material undergoes a corrosion attack. The attack is associated with transport of metallic ions, namely, ferrous and ferric iron, into the bone layer adjacent to the implant. The results comply with an anticipated interplay between released iron ions and osteoclast proliferation. The interplay gives rise to an autocatalytic process in which the iron ions stimulate the osteoclast activity while a formation of fresh bone resorption sites boosts the corrosion process through interactions between acidic osteoclast extracellular compartments and the implant surface. The autocatalytic process thus may account for an accelerated turnover of the peri-implant bone.

Atomic Layer Deposition of Zirconia on Titanium Implants Improves Osseointegration in Rabbit Bones.

Purpose: Atomic layer deposition (ALD) is a method that can deposit zirconia uniformly on an atomic basis. The effect of deposited zirconia on titanium implants using ALD was evaluated in vivo. Methods: Machined titanium implants (MTIs) were used as the Control. MTIs treated by sandblasting with large grit and acid etching (SA) and MTIs deposited with zirconia using ALD are referred to as Groups S and Z, respectively. Twelve implants were prepared for each group. Six rabbits were used as experimental animals. To evaluate the osteogenesis and osteocyte aspects around the implants, radiological and histological analyses were performed. The bone-to-implant contact (BIC) ratio was measured and statistically analyzed to evaluate the osseointegration capabilities. Results: In the micro-CT analysis, more radiopaque bone tissues were observed around the implants in Groups S and Z. Histological observation found that Groups S and Z had more and denser mature bone tissues around the implants in the cortical bone area. Many new and mature bone tissues were also observed in the medullary cavity area. For the BIC ratio, Groups S and Z were significantly higher than the Control in the cortical bone area (P < 0.017), but there was no significant difference between Groups S and Z. Conclusion: MTIs deposited with zirconia using ALD (Group Z) radiologically and histologically showed more mature bone formation and activated osteocytes compared with MTIs (Control). Group Z also had a significantly higher BIC ratio than the Control. Within the limitations of this study, depositing zirconia on the surface of MTIs using ALD can improve osseointegration in vivo.

Assessment of bone ingrowth around beaded coated tibial implant for total ankle replacement using mechanoregulatory algorithm.

The long-term performance of porous coated tibial implants for total ankle replacement (TAR) primarily depends on the extent of bone ingrowth at the bone-implant interface. Although attempts were made for primary fixation for immediate post-operative stability, no investigation was conducted on secondary fixation. The aim of this study is to assess bone ingrowth around the porous beaded coated tibial implant for TAR using a mechanoregulatory algorithm. A realistic macroscale finite element (FE) model of the implanted tibia was developed based on computer tomography (CT) data to assess implant-bone micromotions and coupled with microscale FE models of the implant-bone interface to predict bone ingrowth around tibial implant for TAR. The macroscale FE model was subjected to three near physiological loading conditions to evaluate the site-specific implant-bone micromotion, which were then incorporated into the corresponding microscale model to mimic the near physiological loading conditions. Results of the study demonstrated that the implant experienced tangential micromotion ranged from 0 to 71 µm with a mean of 3.871 µm. Tissue differentiation results revealed that bone ingrowth across the implant ranged from 44 to 96 %, with a mean of around 70 %. The average Young's modulus of the inter-bead tissue layer varied from 1444 to 4180 MPa around the different regions of the implant. The analysis postulates that when peak micromotion touches 30 µm around different regions of the implant, it leads to pronounced fibrous tissues on the implant surface. The highest amount of bone ingrowth was observed in the central regions, and poor bone ingrowth was seen in the anterior parts of the implant, which indicate improper osseointegration around this region. This macro-micro mechanical FE framework can be extended to improve the implant design to enhance the bone ingrowth and in future to develop porous lattice-structured implants to predict and enhance osseointegration around the implant.

Molecular mechanisms of poor osseointegration in irradiated bone: In vivo study in a rat tibia model.

AIM: Radiotherapy is associated with cell depletion and loss of blood supply, which are linked to compromised bone healing. However, the molecular events underlying these effects at the tissue-implant interface have not been fully elucidated. This study aimed to determine the major molecular mediators associated with compromised osseointegration due to previous exposure to radiation. MATERIALS AND METHODS: Titanium implants were placed in rat tibiae with or without pre-exposure to 20 Gy irradiation. Histomorphometric, biomechanical, quantitative polymerase chain reaction (qPCR) and enzyme-linked immunosorbent assay analyses were performed at 1 and 4 weeks after implantation. RESULTS: The detrimental effects of irradiation were characterized by reduced bone-implant contact and removal torque. Furthermore, pre-exposure to radiation induced different molecular dysfunctions such as (i) increased expression of pro-inflammatory (Tnf) and osteoclastic (Ctsk) genes and decreased expression of the bone formation (Alpl) gene in implant-adherent cells; (ii) increased expression of bone formation (Alpl and Bglap) genes in peri-implant bone; and (iii) increased expression of pro-inflammatory (Tnf) and pro-fibrotic (Tgfb1) genes in peri-implant soft tissue. The serum levels of pro-inflammatory, bone formation and bone resorption proteins were greater in the irradiated rats. CONCLUSIONS: Irradiation causes the dysregulation of multiple biological activities, among which perturbed inflammation seems to play a common role in hindering osseointegration.

Adding mechanobiological cell features to finite element analysis of an immediately loaded dental implant.

Finite element analysis (FEA) has been used to analyze the behavior of dental materials, mainly in implantology. However, FEA is a mechanical analysis and few studies have tried to simulate the biological characteristics of the healing process of loaded implants. This study used the rule of mixtures to simulate the biological healing process of immediate implants in an alveolus socket and bone-implant junction interface through FEA. Three-dimensional geometric models of the structures were obtained, and material properties were derived from the literature. The rule of mixtures was used to simulate the healing periods-immediate and early loading, in which the concentration of each cell type, based on in vivo studies, influenced the final elastic moduli. A 100 N occlusal load was simulated in axial and oblique directions. The models were evaluated for maximum and minimum principal strains, and the bone overload was assessed through Frost's mechanostat. There was a higher strain concentration in the healing regions and cortical bone tissue near the cervical portion. The bone overload was higher in the immediate load condition. The method used in this study may help to simulate the biological healing process and could be useful to relate FEA results to clinical practice.

Strategies for Improving Impaired Osseointegration in Compromised Animal Models.

Implant osseointegration is reduced in patients with systemic conditions that compromise bone quality, such as osteoporosis, disuse syndrome, and type 2 diabetes. Studies using rodent models designed to mimic these compromised conditions demonstrated reduced bone-to-implant contact (BIC) or a decline in bone mineral density. These adverse effects are a consequence of disrupted intercellular communication. A variety of approaches have been developed to compensate for the altered microenvironment inherent in compromised conditions, including the use of biologics and implant surface modification. Chemical and physical modification of surface properties at the microscale, mesoscale, and nanoscale levels to closely resemble the surface topography of osteoclast resorption pits found in bone has proven to be a highly effective strategy for improving implant osseointegration. The addition of hydrophilicity to the surface further enhances osteoblast response at the bone-implant interface. These surface modifications, applied either alone or in combination, improve osseointegration by increasing proliferation and osteoblastic differentiation of osteoprogenitor cells and enhancing angiogenesis while modulating osteoclast activity to achieve net new bone formation, although the specific effects vary with surface treatment. In addition to direct effects on surface-attached cells, the communication between bone marrow stromal cells and immunomodulatory cells is sensitive to these surface properties. This article reports on the advances in titanium surface modifications, alone and in combination with novel therapeutics in animal models of human disease affecting bone quality. It offers clinically translatable perspectives for clinicians to consider when using different surface modification strategies to improve long-term implant performance in compromised patients. This review supports the use of surface modifications, bioactive coatings, and localized therapeutics as pragmatic approaches to improve BIC and enhance osteogenic activity from both structural and molecular standpoints.

Compliant Intramedullary Stems for Joint Reconstruction.

The longevity of current joint replacements is limited by aseptic loosening, which is the primary cause of non-infectious failure for hip, knee, and ankle arthroplasty. Aseptic loosening is typically caused either by osteolysis from particulate wear, or by high shear stresses at the bone-implant interface from over-constraint. Our objective was to demonstrate feasibility of a compliant intramedullary stem that eliminates over-constraint without generating particulate wear. The compliant stem is built around a compliant mechanism that permits rotation about a single axis. We first established several models to understand the relationship between mechanism geometry and implant performance under a given angular displacement and compressive load. We then used a neural network to identify a design space of geometries that would support an expected 100-year fatigue life inside the body. We additively manufactured one representative mechanism for each of three anatomic locations, and evaluated these prototypes on a KR-210 robot. The neural network predicts maximum stress and torsional stiffness with 2.69% and 4.08% error respectively, relative to finite element analysis data. We identified feasible design spaces for all three of the anatomic locations. Simulated peak stresses for the three stem prototypes were below the fatigue limit. Benchtop performance of all three prototypes was within design specifications. Our results demonstrate the feasibility of designing patient- and joint-specific compliant stems that address the root causes of aseptic loosening. Guided by these results, we expect the use of compliant intramedullary stems in joint reconstruction technology to increase implant lifetime.

Evaluate the effect of bone density variation on stress distribution at the bone-implant interface using numerical analysis.

The current study aims to comprehend how different bone densities affect stress distribution at the bone-implant interface. This will help understand the behaviour and help predict success rates of the implant planted in different bone densities. The process of implantation involves the removal of bone from a small portion of the jawbone to replace either a lost tooth or an infected one and an implant is inserted in the cavity made as a result. Now the extent of fixation due to osseointegration is largely dependent on the condition of the bone in terms of the density. Generally, the density of the bone is classified into four categories namely D1, D2, D3, and D4; with D1 being purely cortical and D4 having higher percentage of cancellous bordered by cortical bone. A bone model with a form closely resembling the actual bone was made using 3D CAD software and was meshed using Hyper Mesh. The model was subjected to an oblique load of 120 N at 70° to the vertical to replicate occlusal loading. A finite element static analysis was done using Abaqus software. The stress distribution contours at the bone-implant contact zone were studied closely to understand the changes as a result of the varying density. It was revealed that as the quantity of the cancellous bone increased from D1 to D4 the cortical peak stress levels dropped. The bone density and the corresponding change in the material characteristics was also responsible for the variation in the peak stress and displacement values.

Impact of enhancement filters of a CMOS system on halo artifact expression at the bone-to-implant interface.

OBJECTIVE: To assess the impact of enhancement filters on the formation of halo artifacts in radiographs of dental implants obtained with a complementary metal oxide semiconductor (CMOS) system. METHODS: Digital radiographs of dental implants placed in dry human mandibles were processed with the Noise Reduction smoothing filter, as well as the Sharpen 1, Sharpen 4, and Sharpen UM high-pass filters available in the CLINIVIEW™ software (Instrumentarium Dental, Tuusula, Finland). Subjective analysis involved evaluating the left, right, and apical surfaces of each implant for the presence of much, few, or no halo. The objective analysis involved measurement of the halo area using the Trainable Weka Segmentation plugin (ImageJ, National Institutes of Health, Bethesda, MD, USA). Data were analyzed using Friedman's test (subjective analysis) and ANOVA (objective analysis) (α = 5%). RESULTS: In the subjective evaluation, the Sharpen 4 filter produced more radiographs with much halo present, and in the objective evaluation, a bigger halo area when compared to the original images and the Noise Reduction filter for all surfaces (p < 0.05). CONCLUSIONS: When evaluating dental implants, priority should be given to original images and those enhanced with smoothing filters since they exhibit fewer halo artifacts. CLINICAL RELEVANCE: Post-processing tools, such as enhancement filters, may improve the image quality and assist some diagnostic tasks. However, little is known regarding the impact of enhancement filters in halo formation on CMOS systems, which have been increasingly used in dental offices.

Two-Photon-Excited FLIM of NAD(P)H and FAD-Metabolic Activity of Fibroblasts for the Diagnostics of Osteoimplant Survival.

Bioinert materials such as the zirconium dioxide and aluminum oxide are widely used in surgery and dentistry due to the absence of cytotoxicity of the materials in relation to the surrounding cells of the body. However, little attention has been paid to the study of metabolic processes occurring at the implant-cell interface. The metabolic activity of mouse 3T3 fibroblasts incubated on yttrium-stabilized zirconium ceramics cured with aluminum oxide (ATZ) and stabilized zirconium ceramics (Y-TZP) was analyzed based on the ratio of the free/bound forms of cofactors NAD(P)H and FAD obtained using two-photon microscopy. The results show that fibroblasts incubated on ceramics demonstrate a shift towards the free form of NAD(P)H, which is observed during the glycolysis process, which, according to our assumptions, is related to the porosity of the surface of ceramic structures. Consequently, despite the high viability and good proliferation of fibroblasts assessed using an MTT test and a scanning electron microscope, the cells are in a state of hypoxia during incubation on ceramic structures. The FLIM results obtained in this work can be used as additional information for scientists who are interested in manufacturing osteoimplants.

Quantifying the immediate post-implantation strain field of cadaveric tibiae implanted with cementless tibial trays: A time-elapsed micro-CT and digital volume correlation analysis during stair descent.

Primary stability, the mechanical fixation between implant and bone prior to osseointegration, is crucial for the long-term success of cementless tibial trays. However, little is known about the mechanical interplay between the implant and bone internally, as experimental studies quantifying internal strain are limited. This study employed digital volume correlation (DVC) to quantify the immediate post-implantation strain field of five cadaveric tibiae implanted with a commercially available cementless titanium tibial tray (Attune, DePuy Synthes). The tibiae were subjected to a five-step loading sequence (0-2.5 bodyweight, BW) replicating stair descent, with concomitant time-elapsed micro-CT imaging. With progressive loads, increased compression of trabecular bone was quantified, with the highest strains directly under the posterior region of the tibial tray implant, dissipating with increasing distance from the bone-implant interface. After load removal of the last load step (2.5BW), residual strains were observed in all of the five tibiae, with residual strains confined within 3.14 mm from the bone-implant interface. The residual strain is reflective of the observed initial migration of cementless tibial trays reported in clinical studies. The presence of strains above the yield strain of bone accepted in literature suggests that inelastic properties should be included within finite element models of the initial mechanical environment. This study provides a means to experimentally quantify the internal strain distribution of human tibia with cementless trays, increasing the understanding of the mechanical interaction between bone and implant.

The effect of coating characteristics on implant-bone interface mechanics.

Successful osseointegration of press-fit implants depends on the initial stability, often measured by the micromotions between the implant and bone. A good primary stability can be achieved by optimizing the compressive and frictional forces acting at the bone-implant interface. The frictional properties of the implant-bone interface, which depend on the roughness and porosity of the implant surface coating, can affect the primary stability. Several reversible (elastic) and non-reversible (permanent) deformation processes take place during frictional loading of the implant-bone interface. In case of a rough coating, the asperities of the implant surface are compressed into the bone leading to mechanical interlocking. To optimize fixation of orthopaedic implants it is crucial to understand these complex interactions between coating and bone. The objective of the current study was to gain more insight into the reversible and non-reversible processes acting at the implant-bone interface. Tribological experiments were performed with two types of porous coatings against human cadaveric bone. The results indicated that the coefficient of friction depended on the coating roughness (0.86, 0.95, and 0.45 for an Ra roughness of 41.2, 53.0, and a polished surface, respectively). Larger elastic and permanent displacements were found for the rougher coating, resulting in a lower interface stiffness. The experiments furthermore revealed that relative displacements of up to 35 µm can occur without sliding at the interface. These findings have implications for micromotion thresholds that currently are assumed for osseointegration, and suggest that bone ingrowth actually occurs in the absence of relative sliding at the implant-bone interface.

Informatics guided FE design of bioactive titanium alloy/composite multi-layered dental implants.

A dental implant with three distinct layers, of titanium alloy at core, porous titanium alloy at the intermediate layer and titanium alloy hydroxyapatite composite at the outer layer, is designed to achieve low elastic modulus and adequate strength with bioactive surface. Artificial Neural Network (ANN) along with Rule of Mixture (ROM) is used to generate the objective functions for the Genetic Algorithm (GA) based multi-objective optimization for achieving the optimal designs, which are validated using Finite Element Analysis (FEA) simulations. The composition and processing parameters are correlated with the yield strength and elastic modulus of titanium alloy using ANN. The ANN models are generated to express the strength and effective modulus of the implant using ROM. To determine the optimal composition of titanium alloys, porous layers, and composite layers for a three-layer dental implant, multi-objective genetic algorithm is employed. The Pareto optimal solutions provide the guidelines for designing the implant. A few selected non-dominated solutions are used for studying the actual stress distribution at the bone-implant interface using FEA, and showed significant improvements compared to conventional implants.

A novel artificial vertebral implant with Gyroid porous structures for reducing the subsidence and mechanical failure rate after vertebral body replacement.

BACKGROUND: Prosthesis subsidence and mechanical failure were considered significant threats after vertebral body replacement during the long-term follow-up. Therefore, improving and optimizing the structure of vertebral substitutes for exceptional performance has become a pivotal challenge in spinal reconstruction. METHODS: The study aimed to develop a novel artificial vertebral implant (AVI) with triply periodic minimal surface Gyroid porous structures to enhance the safety and stability of prostheses. The biomechanical performance of AVIs under different loading conditions was analyzed using the finite element method. These implants were fabricated using selective laser melting technology and evaluated through static compression and subsidence experiments. RESULTS: The results demonstrated that the peak stress in the Gyroid porous AVI was consistently lower than that in the traditional porous AVI under all loading conditions, with a maximum reduction of 73.4%. Additionally, it effectively reduced peak stress at the bone-implant interface of the vertebrae. Static compression experiments demonstrated that the Gyroid porous AVI was about 1.63 times to traditional porous AVI in terms of the maximum compression load, indicating that Gyroid porous AVI could meet the safety requirement. Furthermore, static subsidence experiments revealed that the subsidence tendency of Gyroid porous AVI in polyurethane foam (simulated cancellous bone) was approximately 15.7% lower than that of traditional porous AVI. CONCLUSIONS: The Gyroid porous AVI exhibited higher compressive strength and lower subsidence tendency than the strut-based traditional porous AVI, indicating it may be a promising substitute for spinal reconstruction.

The influence of hip revision stem spline design on the torsional stability in the presence of major proximal bone defects.

BACKGROUND: Despite the success of primary total hip arthroplasty, the number of revisions remains high. Infection, aseptic loosening, periprosthetic fractures and dislocations are the leading causes of hip revision. Current revision stem designs feature a tapered body with circumferential placed longitudinal thin metal splines that cut into the femoral cortex of the diaphysis to provide axial and rotational stability. Modifications to the spline design may help improve primary stability in various bone qualities. The purpose of this study was to evaluate whether the rotational stability of a revision hip stem can be improved by an additional set of less prominent, wider splines in addition to the existing set of splines. It is hypothesized that the additional splines will result in greater cortical contact, thereby improving torsional strength. METHODS AND FINDINGS: The ultimate torsional strength of an established modular revision stem (Reclaim®, DePuy Synthes) was compared to a Prototype stem design with two sets of splines, differing in prominence by 0.25 mm. Five pairs of fresh-frozen human femurs (n = 10) were harvested and an extended trochanteric osteotomy was performed to obtain common bone defects in revision. Stems were implanted using successive droptower impacts to omit variability caused by mallet blows. The applied energy was increased from 2 J in 1 J increments until the planned implantation depth was reached or seating was less than 0.5 mm at 5 J impact. The ultimate torsional strength of the bone-to-implant interface was determined immediately after implantation. Image superposition was used to analyze and quantify the contact situation between bone and implant within the femoral canal. Cortical contact was larger for the Prototype design with the additional set of splines compared to the Reclaim stem (p = 0.046), associated with a higher torsional stability (35.2 ± 6.0 Nm vs. 28.2 ± 3.5 Nm, p = 0.039). CONCLUSIONS: A second set of splines with reduced prominence could be shown to improve primary stability of a revision stem in the femoral diaphysis in the presence of significant proximal bone loss. The beneficial effect of varying spline size and number has the potential to further improve the longevity of revision hip stems.

Antibiotic prophylaxis dysregulates dental implant placement surgery-induced osteoimmune wound healing and attenuates the alveolar bone-implant interface in mice.

AIM: Antimicrobial-induced shifts in commensal oral microbiota can dysregulate helper T-cell oral immunity to affect osteoclast-osteoblast actions in alveolar bone. Antibiotic prophylaxis is commonly performed with dental implant placement surgery to prevent post-surgical complications. However, antibiotic prophylaxis effects on osteoimmune processes supporting dental implant osseointegration are unknown. The aim of the study was to discern the impact of antibiotic prophylaxis on dental implant placement surgery-induced osteoimmune wound healing and osseointegration. MATERIALS AND METHODS: We performed SHAM or dental implant placement surgery in mice. Groups were administered prophylactic antibiotics (amoxicillin or clindamycin) or vehicle. Gingival bacteriome was assessed via 16S sequencing. Helper T-cell oral immunity was evaluated by flow cytometry. Osteoclasts and osteoblasts were assessed via histomorphometry. Implant osseointegration was evaluated by micro-computed tomography. RESULTS: Dental implant placement surgery up-regulated TH 1, TH 2 and TREG cells in cervical lymph nodes (CLNs), which infers helper T-cell oral immunity contributes to dental implant placement osseous wound healing. Prophylactic antibiotics with dental implant placement surgery caused a bacterial dysbiosis, suppressed TH 1, TH 2 and TREG cells in CLNs, reduced osteoclasts and osteoblasts lining peri-implant alveolar bone, and attenuated the alveolar bone-implant interface. CONCLUSIONS: Antibiotic prophylaxis dysregulates dental implant placement surgery-induced osteoimmune wound healing and attenuates the alveolar bone-implant interface in mice.

[Mid-term effectiveness of hip preservation in the reconstruction of ultrashort bone segments in the proximal femur with three-dimensional printed customized cementless intercalary endoprosthesis with an intra-neck curved stem].

Objective: To explore the design points of a three-dimensional (3D) printed customized cementless intercalary endoprosthesis with an intra-neck curved stem and to evaluate the key points and mid-term effectiveness of its application in the reconstruction of ultrashort bone segments in the proximal femur. Methods: Between October 2015 and January 2021, 17 patients underwent reconstruction with a 3D printed-customized cementless intercalary endoprosthesis with an intra-neck curved stem. There were 11 males and 6 females, the age ranged from 10 to 76 years, with an average of 30.1 years. There were 9 cases of osteosarcoma, 4 cases of Ewing sarcoma, 2 cases of chondrosarcoma, 1 case of liposarcoma, and 1 case of myofibroblastoma. The disease duration was 5-14 months, with an average of 9.5 months. Enneking staging included 16 cases of stage ⅡB and 1 case of stage ⅢB. The distances from the center of the femoral head to the body midline and the acetabular apex were measured preoperatively on X-ray images. Additionally, the distances from the tip of the intra-neck curved stem to the body midline and the acetabular apex were measured at immediate postoperatively and last follow-up. The neck-shaft angle was also measured preoperatively, at immediate postoperatively, and at last follow-up. The status of osseointegration at the bone-prosthesis interface and bone growth into the prosthesis surface were assessed by X-ray films, CT, and Tomosynthesis-Shimadzu metal artefact reduction technology (T-SMART). The survival status of the patients, presence of local recurrence or distant metastasis, and occurrence of postoperative complications were assessed. The recovery of lower limb function was evaluated pre- and post-operatively using the Musculoskeletal Tumor Society (MSTS) scoring system, and pain relief was evaluated using the visual analogue scale (VAS) scores. Results: The patient's femoral resection length was (163.1±57.5) mm, the remaining proximal femoral length was (69.6±9.3) mm, and the percentage of femoral resection length/total femoral length was 38.7%±14.6%. All 17 patients were followed up 25-86 months with an average of 58.1 months. During the follow-up, 1 patient died of lung metastasis at 46 months postoperatively, and the remaining 16 patients survived tumor-free. There was no complication such as periprosthetic infection, delayed incision healing, aseptic loosening, prosthesis fracture, or periprosthetic fracture. No evidence of micromotion or wear around the implanted stem of the prosthesis was detected in X-ray and T-SMART evaluations. There was no significant radiolucent lines, and radiographic evidence of bone ingrowth into the bone-prosthesis interface was observed in all stems. There was no significant difference in the distance from the tip of the curved stem to the body midline and the apex of the acetabulum at immediate postoperatively and last follow-up compared with the distance from the center of the femoral head to the body midline and the apex of the acetabulum before operation, respectively (P>0.05), and there was no significant difference in the above indexes between immediate postoperatively and last follow-up (P>0.05). The differences in the neck-shaft angle at various time points before and after operation were also not significant (P>0.05). At last follow-up, the MSTS score was 26.1±1.2 and the VAS score was 0.1±0.5, which were significantly improved when compared with those before operation [19.4±2.1 and 5.7±1.0, respectively] (t=14.735, P<0.001; t=21.301, P<0.001). At last follow-up, none of the patients walked with the aid of crutches or other walkers. Conclusion: The 3D printed customized cementless intercalary endoprosthesis with an intra-neck curved stem is an effective method for reconstructing ultrashort bone segments in the proximal femur following malignant tumor resection. The operation is reliable, the postoperative lower limb function is satisfactory, and the incidence of complications is low.

Finite element analysis of a customized implant in PMMA coupled with the cranial bone.

This computational study investigates the effect of the Von Misses stresses and deformations distribution generated by coupling a customized cranial implant with its fixation system for anchoring in the cranial bone of a specific patient. Three simulations were carried out under static loads, in different areas of the implant and during the rest-activity; and another three simulations were considered preset maximum intracranial pressures. Anatomical models were obtained by computed tomography. The design of the device to be implanted was carried out by applying reverse engineering processes, from the corresponding computer-aided design (CAD) model of the bone structure of interest. Likewise, the anchoring system was modeled in detail. Loads were applied at three points on the custom implant. The stress distribution on the artificial plate and the implant-natural bone interface was analyzed. The distribution of the stresses caused by the internal load states on the plate and the anchoring system was also studied. The neurocranial reconstruction with the customized polymethylmethacrylate (PMMA)-based implant and the finite element analysis demonstrated that the fixation and coupling system of the bone-implant interface guarantees adequate protection for the internal structures of the restored area. In addition, the custom-designed and placed implant will not cause non-physiological harm to the patient. Nor will failures occur in the anchoring system.