TiNbSn stems with gradient changes of Young's modulus and stiffness reduce stress shielding compared to the standard fit-and-fill stems.

BACKGROUND: The difference between Young's moduli of the femur and the stem causes stress shielding (SS). TiNbSn (TNS) stem has a low Young's modulus and strength with gradient functional properties during the change in elastic modulus with heat treatment. The aim of this study was to investigate the inhibitory effect of TNS stems on SS and their clinical outcomes compared to conventional stems. METHODS: This study was a clinical trial. Primary THA was performed using a TNS stem from April 2016 to September 2017 for patients in the TNS group. Unilateral THA was performed using a Ti6Al4V alloy stem from January 2007 to February 2011 for patients in the control group. The TNS and Ti6Al4V stems were matched in shape. Radiographs were obtained at the 1- and 3-year follow-ups. Two surgeons independently checked the SS grade and appearance of cortical hypertrophy (CH). The Japanese Orthopaedic Association (JOA) scores before and 1 year after surgery were assessed as clinical scores. RESULTS: None of the patients in the TNS group had grade 3 or 4 SS. In contrast, in the control group, 24% and 40% of patients had grade 3 and 4 SS at the 1- and 3-year follow-ups, respectively. The SS grade was lower in the TNS group than in the control group at the 1- and 3-year follow-ups (p < 0.001). The frequencies of CH in both groups were no significant difference at the 1- and 3-year follow-ups. The JOA scores of the TNS group significantly improved at 1 year after surgery and were comparable to control group. CONCLUSION: The TNS stem reduced SS at 1 and 3 years after THA compared to the proximal-engaging cementless stem, although the shapes of the stems matched. The TNS stem could reduce SS, stem loosening, and periprosthetic fractures. TRIAL REGISTRATION: Current Controlled Trials. ISRCTN21241251. https://www.isrctn.com/search?q=21241251 . The date of registration was October 26, 2021. Retrospectively registered.

Impacts of external rotators and the ischiofemoral ligament on preventing excessive internal hip rotation: a cadaveric study.

BACKGROUND: This study examined the biomechanics of preventing excessive internal hip joint rotation related to the hip flexion angle. METHOD: An intramedullary nail with a circular plate equipped with a protractor was installed in the femur of nine normal hips. The circular plate was pulled by 3.15 Nm of force in the internal rotation direction. The external rotators were individually resected, finally cutting the ischiofemoral ligament. The cutting order of the external rotators differed on each side to individually determine the internal rotation resistance. The external rotators were resected from the piriformis to the obturator externus in the right hips and the reverse order in the left hips. Traction was performed after excising each muscle and ischiofemoral ligament. Measurements were taken at 0°, 30°, and 60° of hip flexion, and the differences from baseline were calculated. RESULTS: For the right hip measurements, the piriformis and ischiofemoral ligament resection significantly differed at 0° of flexion (p = 0.02), each external rotator and the ischiofemoral ligament resections significantly differed at 30° of flexion (p < 0.01), and the ischiofemoral ligament and piriformis and inferior gemellus resections significantly differed at 60° of flexion (p = 0.04 and p = 0.02, respectively). In the left hips, the ischiofemoral ligament and obturator externus, inferior gemellus, and obturator internus resections significantly differed at 0° of flexion (p < 0.01, p < 0.01, and p = 0.01, respectively), as did each external rotator and the ischiofemoral ligament resections at 30° of flexion (p < 0.01). CONCLUSION: The ischiofemoral ligament primarily restricted the internal rotation of the hip joint. The piriformis and obturator internus may restrict internal rotation at 0° and 60° of flexion.

Acceleration of Fracture Healing in Mouse Tibiae Using Intramedullary Nails Composed of ß-Type TiNbSn Alloy with Low Young's Modulus.

The optimal Young's modulus of material of orthopedic devices for fracture treatment is still unknown. The purpose of present study was to evaluate the impacts of intramedullary nails composed of a titanium alloy with low Young's modulus, on accelerating fracture healing compared with stainless steel with high Young's modulus. A ß-type TiNbSn alloy with a low Young's modulus close to that of human cortical bone was developed for clinical application. TiNbSn alloy with a Young's modulus of 45 GPa and stainless steel with a Young's modulus of 205 GPa were compared, with respect to the impacts on fracture healing. Fracture and fixation using intramedullary nail were performed on the right tibiae of C57BL/6 mice. The assessment of bone healing was performed via micro-computed tomography, histomorphometry, and quantitative reverse transcription polymerase chain reaction. In micro-computed tomography, larger bone volumes were observed in the fracture callus treated with TiNbSn alloy in comparison with those treated with stainless steel. Histological assessments confirmed accelerated cartilage absorption and new bone formation in the TiNbSn alloy group compared with the stainless steel group. The expression of Col1a1, Runx2, Dkk1, and Acp5 was higher in the TiNbSn alloy group, while that of Col2a1 and Col10a1 was lower in the late phase. The present study demonstrated that the fixation by intramedullary nails with TiNbSn alloy offered an accelerated fracture healing with promotion of bone formation via increased Runx2 expression. TiNbSn alloy might be a promising material for fracture treatment devices.

Improved Osseointegration of a TiNbSn Alloy with a Low Young's Modulus Treated with Anodic Oxidation.

Ti6Al4V alloy orthopedic implants are widely used as Ti6Al4V alloy is a biocompatible material and resistant to corrosion. However, Ti6Al4V alloy has higher Young's modulus compared with human bone. The difference of elastic modulus between bone and titanium alloy may evoke clinical problems because of stress shielding. To resolve this, we previously developed a TiNbSn alloy offering low Young's modulus and improved biocompatibility. In the present study, the effects of sulfuric acid anodic oxidation on the osseointegration of TiNbSn alloy were assessed. The apatite formation was evaluated with Scanning electron microscopy, X-ray diffraction, X-ray photoelectron spectroscopy and transmission electron microscopy analyses. The biocompatibility of TiNbSN alloy was evaluated in experimental animal models using pull-out tests and quantitative histological analyses. The results of the surface analyses indicated that sulfuric anodic oxidation induced abundant superficial apatite formation of the TiNbSn alloy disks and rods, with a 5.1-µm-thick oxide layer and submicron-sized pores. In vivo, treated rods showed increased mature lamellar bone formation and higher failure loads compared with untreated rods. Overall, our findings indicate that anodic oxidation with sulfuric acid may help to improve the biocompatibility of TiNbSn alloys for osseointegration.

Effects of elastic intramedullary nails composed of low Young's modulus Ti-Nb-Sn alloy on healing of tibial osteotomies in rabbits.

Intramedullary nailing is widely performed for internal fixation of fractures. The applicable elasticity of materials composing intramedullary nails remains unclear. The present study aimed to evaluate the effects of the elastic property of ß-type titanium alloy nails on fracture healing compared with conventional Ti-6Al-4V alloy nails using a rabbit tibial osteotomy model. Two types of intramedullary nails composed of ß-type Ti-Nb-Sn alloy (Young's modulus: 37 GPa) or Ti-6Al-4V alloy (Young's modulus: 110 GPa) were used for osteotomy fixation in the tibiae of rabbits. At 4, 8, and 16 weeks postoperatively, microcomputed tomography (micro-CT) and three-point bending tests were performed. Micro-CT images showed that the callus volume was significantly larger in the Ti-Nb-Sn alloy group at 4 and 8 weeks. The callus bone mineral density did not differ at each time point. In mechanical testing, the maximum load was significantly higher at all time points in the Ti-Nb-Sn alloy group. Taken together, the elastic intramedullary nails composed of Ti-Nb-Sn alloy improved the mechanical properties of the bone healing site from the early phase to the remodeling phase. Adequate Young's modulus of the Ti-Nb-Sn alloy enhanced fracture union and bone strength restoration. The Ti-Nb-Sn alloy is a promising biomaterial for fracture fixation devices. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2018. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 700-707, 2019.

Assessment of the risk of low bone mineral density in premenopausal Japanese female patients with systemic lupus erythematosus.

BACKGROUND: The aim of this study was to assess the relationships between clinical parameters and bone mineral density (BMD) in Japanese female patients with systemic lupus erythematosus (SLE). METHODS: A total of female 136 SLE patients without menopause were retrospectively assessed to identify associations between age, disease duration, body mass index (BMI), glucocorticoid usage and disease activity and BMD based on the treatment with or without bisphosphonate. There were 71 patients treated with bisphosphonate (bisphosphonate group) and 65 patients without (non-bisphosphonate group). We evaluated the impact of age, disease duration, BMI, serologic SLE markers, glucocorticoid use on BMD of the anterior-posterior (AP) and lateral lumbar spine, total hip and femoral neck using univariate and multivariate linear regression analyses of both bisphosphonate and non-bisphosphonate groups. RESULTS: Multivariate linear regression analyses showed that in non-bisphosphonate group disease duration was negatively associated with BMD of AP spine and femoral neck, whereas in bisphosphonate group these negative associations were not present. However, multivariate linear regression analyses showed a significant relationship between BMI and BMD of the AP spine, femoral neck and total hip, regardless of bisphosphonate treatment. CONCLUSIONS: Bisphosphonate treatment eliminated the negative relationships between disease duration and the BMD of the spine and hip. AP spine and hip BMD in patients with SLE depend on BMI, regardless of bisphosphonate use. SLE serologic markers and glucocorticoid use were not negatively associated with generalized bone loss. SLE patients with low BMI have a high risk of generalized bone loss, and should be assessed and treated to prevent osteoporosis even before menopause.

Effects of intramedullary nails composed of a new ß-type Ti-Nb-Sn alloy with low Young's modulus on fracture healing in mouse tibiae.

The influence of Young's moduli of materials on the fracture healing process remains unclear. This study aimed to assess the effects of intramedullary nails composed of materials with low Young's moduli on fracture repair. We previously developed a ß-type Ti-Nb-Sn alloy with low Young's modulus close to that of human cortical bone. Here, we prepared two Ti-Nb-Sn alloys with Young's moduli of 45 and 78 GPa by heat treatment, and compared their effects on fracture healing. Fracture and nailing were performed in the right tibiae of C57BL/6 mice. The bone healing process was evaluated by microcomputed tomography (micro-CT), histomorphometry, and RT-PCR. We found larger bone volumes of fracture callus in the mice treated with the 45-GPa Ti-Nb-Sn alloy as compared with the 78-GPa Ti-Nb-Sn alloy in micro-CT analyses. This was confirmed with histology at day 14, with accelerated new bone formation and cartilage absorption in the 45-GPa Ti-Nb-Sn group compared with the 78-GPa Ti-Nb-Sn group. Acp5 expression was lower in the 45-GPa Ti-Nb-Sn group than in the 78-GPa Ti-Nb-Sn group at day 10. These findings indicate that intramedullary fixation with nails with a lower Young's modulus offer a greater capacity for fracture repair. Our 45-GPa Ti-Nb-Sn alloy is a promising material for fracture treatment implants. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2841-2848, 2018.

Apatite Formation and Biocompatibility of a Low Young's Modulus Ti-Nb-Sn Alloy Treated with Anodic Oxidation and Hot Water.

Ti-6Al-4V alloy is widely prevalent as a material for orthopaedic implants because of its good corrosion resistance and biocompatibility. However, the discrepancy in Young's modulus between metal prosthesis and human cortical bone sometimes induces clinical problems, thigh pain and bone atrophy due to stress shielding. We designed a Ti-Nb-Sn alloy with a low Young's modulus to address problems of stress disproportion. In this study, we assessed effects of anodic oxidation with or without hot water treatment on the bone-bonding characteristics of a Ti-Nb-Sn alloy. We examined surface analyses and apatite formation by SEM micrographs, XPS and XRD analyses. We also evaluated biocompatibility in experimental animal models by measuring failure loads with a pull-out test and by quantitative histomorphometric analyses. By SEM, abundant apatite formation was observed on the surface of Ti-Nb-Sn alloy discs treated with anodic oxidation and hot water after incubation in Hank's solution. A strong peak of apatite formation was detected on the surface using XRD analyses. XPS analysis revealed an increase of the H2O fraction in O 1s XPS. Results of the pull-out test showed that the failure loads of Ti-Nb-Sn alloy rods treated with anodic oxidation and hot water was greater than those of untreated rods. Quantitative histomorphometric analyses indicated that anodic oxidation and hot water treatment induced higher new bone formation around the rods. Our findings indicate that Ti-Nb-Sn alloy treated with anodic oxidation and hot water showed greater capacity for apatite formation, stronger bone bonding and higher biocompatibility for osteosynthesis. Ti-Nb-Sn alloy treated with anodic oxidation and hot water treatment is a promising material for orthopaedic implants enabling higher osteosynthesis and lower stress disproportion.

Systemic resistance induced in Arabidopsis thaliana by Trichoderma asperellum SKT-1, a microbial pesticide of seedborne diseases of rice.

BACKGROUND: Trichoderma asperellum SKT-1 is a microbial pesticide of seedborne diseases of rice. To investigate the mechanisms of disease suppression in SKT-1, the ability to induce systemic resistance by SKT-1, or its cell-free culture filtrate (CF), was tested using Arabidopsis thaliana Col-0 plants. RESULTS: Both SKT-1 and its CF elicit an induced systemic resistance against the bacterial leaf speck pathogen Pseudomonas syringae pv. tomato DC3000 in Col-0 plants. Involvement of plant hormones in the induced resistance by SKT-1 and CF was assessed using Arabidopsis genotypes such as the jasmonic acid (JA)-resistant mutant jar1, the ethylene (ET)-resistant mutant etr1, the plant impaired in salicylic acid (SA) signalling transgenic NahG and the mutant npr1 impaired in NPR1 activity. In soil experiments using SKT-1, no significant disease suppression effect was observed in NahG transgenic plants or npr1 mutant plants. Expression levels of SA-inducible genes such as PR-1, PR-2 and PR-5 increased substantially in the leaves of Col-0 plants. Expression levels of JA/ET-induced genes such as PDF1.2a, PR-3, PR-4 and AtVsp1 were also induced, but the levels were not as high as for SA-inducible genes. In a hydroponic experiment using CF from SKT-1, all Arabidopsis genotypes showed an induced systemic resistance by CF and increased expression levels of JA/ET- and SA-inducible genes in leaves of CF-treated plants. CONCLUSION: The SA signalling pathway is important in inducing systemic resistance to colonisation by SKT-1, and both SA and JA/ET signalling pathways combine in the signalling of induced resistance by CF. These results indicate that the response of A. thaliana is different from that found in root treatments with barley grain inoculum and CF from SKT-1.