多孔钛合金不同孔径大小对新骨长入的影响

目的:评价不同孔径多孔钛合金植入物在骨缺损区对新骨长入的影响。方法:采用电子束熔融(EBM)技术制备三种不同孔径(孔径分别为1.0 mm,2.0 mm,3.0 mm)的多孔钛合金材料,其孔隙率依次为73%,79%,86%。将18只家犬随机分为1.0 mm孔径材料组,2.0 mm孔径材料组,3.0 mm孔径材料组,每组6只。制备家犬双侧股骨外侧髁缺损模型,然后植入各孔径组材料,于术后4周,8周,12周分别行大体标本观察,X线片观察,组织形态学观察三组不同孔径材料与周围骨的整合情况及孔隙中的新骨长入情况。结果:通过大体标本观察和X线片观察显示,12周后三组材料均与周围紧密骨连接。其中1.0 mm孔径组材料中心明显成骨,2.0 mm孔径组和3.0 mm孔径组中心仍为较多白色组织填充。组织学观察显示,12周时2.0 mm孔径组和3.0 mm孔径组材料周围有骨质包绕,但中心空洞,基本无骨质形成。1.0 mm孔径组材料周围骨质包绕紧密,孔中新生骨形成较多,且有大量纤维母细胞和软骨细胞形成。各时间点1.0 mm孔径组新生骨面积百分比明显高于2.0 mm孔径组和3.0 mm孔径组,P<0.01,差异具有统计学意义。2.0 mm孔径组和3.0 mm孔径组相比,P>0.05,无显著差异。结论:孔径大小影响多孔钛合金材料的骨长入,适当孔径的设计将更有利于材料的传导成骨。     

Mechanical study of spinal interbody implants--characteristics and limits of standardized testing]

Spinal interbody fusion has proved to be a useful procedure for the surgical stabilization of spinal segments, for which fusion cases made of metal or reinforced polymers are increasingly being used. For the mechanical testing of spinal interbody implants, a test setup has been developed on the basis of an ASTM proposal. Initially, testing of lumbar fusion cages made of CFRP (carbon fibre reinforced polymer) was carried out. The implants (UNION Cages, Medtronic Sofamor Danek), which are characterised by their radiolucency on radiography, NMR and CT scans, have a cube-shaped body with three table-tracks on the under and upper surfaces. The cages were tested at different loads. Modifications of the proposed standardized method were carried out to enable implementation of implant-oriented testing. The tested cages were shown to have adequate axial compression, shear and torsional strengths with regard to the implant body. The maximum axial compression force tolerated by the table-tracks was less than the maximal potential loading of the lumbar spine, and, with account being taken of implant design, consequences with regard to surgical technique were drawn. As dictated by the geometry of the table-tracks, parallel grooves have to be made intra-operatively in the vertebral end plates. Axial compressive loads then act on the implant body, and the table-tracks are protected from damage. To avoid in vivo failure, the tested cages should be implanted only when this specific surgical technique is employed. Using supplementary anterior or posterior instrumentation, in vivo failure of the table-tracks under physiological spinal loading is not to be expected.     

A Controllable Carmine Technic for Plants with Small Chromosomes

Anthers of small chromosome plants (Antirrhinum, Brassica, Capsicum etc.) were fixed 12 hours or longer at 0–3° C. in: ferric acetate in glacial acetic acid (sat. soln.), 1 part; absolute alcohol, 3 parts. They were transferred to: ferric acetate (sat. soln.) in 45% acetic acid, 3 parts; 45% acetic acid, 5 parts; 1% formalin (aq.), 2 parts, and allowed to remain 5–15 minutes at room temperature for mordanting. The amount of iron introduced into the specimens was controllable by the time in the mordanting fluid. After rinsing the specimen in 45% acetic acid and macerating in a drop of Belling's acetocarmine on a slide, a cover slip was applied followed by warming and pressing with blotting paper to flatten the pollen mother cells and expel excess stain. Preparations stored temporarily by sealing the edges of the cover slip with rubber solution were best made permanent by removing the cover slip after 1–2 days, dehydrating and mounting in euparal.     

Effect of surface roughness of Ti, Zr, and TiZr on apatite precipitation from simulated body fluid

Some of the critical properties for a successful orthopedic or dental implant material are its biocompatibility and bioactivity. Pure titanium (Ti) and zirconium (Zr) are widely accepted as biocompatible metals, due to their non-toxicity. While the bioactivity of Ti and some Ti alloys has been extensively investigated, there is still insufficient data for Zr and titanium-zirconium (TiZr) alloys. In the present study, the bioactivity, that is, the apatite forming ability on the alkali and heat treated surfaces of Ti, Zr, and TiZr alloy in simulated body fluid (SBF), was studied. In particular, the effect of the surface roughness characteristics on the bioactivity was evaluated for the first time. The results indicate that the pretreated Ti, Zr and TiZr alloy could form apatite coating on their surfaces. It should be noted that the surface roughness also critically affected the bioactivity of these pretreated metallic samples. A surface morphology with an average roughness of approximately 0.6 microm led to the fastest apatite formation on the metal surfaces. This apatite layer on the metal surface is expected to bond to the surrounding bones directly after implantation.     

Bone remodelling around the tibia due to total ankle replacement: effects of implant material and implant–bone interfacial conditions

Abstract

One of the major causes of implant loosening is due to excessive bone resorption surrounding the implant due to bone remodelling. The objective of the study is to investigate the effects of implant material and implant–bone interface conditions on bone remodelling around tibia bone due to total ankle replacement. Finite element models of intact and implanted ankles were developed using CT scan data sets. Bone remodelling algorithm was used in combination with FE analysis to predict the bone density changes around the ankle joint. Dorsiflexion, neutral, and plantar flexion positions were considered, along with muscle force and ligaments. Implant–bone interfacial conditions were assumed as debonded and bonded to represent non-osseointegration and fully osseointegration at the porous coated surface of the implant. To investigate the effect of implant material, three finite element models having different material combinations of the implant were developed. For model 1, tibial and talar components were made of Co–Cr–Mo, and meniscal bearing was made of UHMWPE. For model 2, tibial and talar components were made of ceramic and meniscal bearing was made of UHMWPE. For model 3, tibial and talar components were made of ceramic and meniscal bearing was made of CFR-PEEK. Changes in implant material showed no significant changes in bone density due to bone remodelling. Therefore, ceramic appears to be a viable alternative to metal and CFR-PEEK can be used in place of UHMWPE. This study also indicates that proper bonding between implant and bone is essential for long-term survival of the prosthetic components.     

骨科假体表面涂层技术现状

由植入物界面处的相互作用可能引起无菌性松动和假体周围感染。而无菌性松动和假体周围感染仍然是一个难以治疗的问题,并且最终可能导致假体植入失败,引起严重后果。理想的植入物应能促进骨整合,防止细菌粘附,减少细菌感染。骨科植入技术主要基于生物材料的开发和使用,随着材料科学和细胞生物学的发展,已可以用新的植入物表面涂层的进展来解决这些问题。本文回顾总结了时下骨科常见的假体涂层设计和相关问题,以期为进一步研究提供借鉴。     

Finite element simulations of a focal knee resurfacing implant applied to localized cartilage defects in a sheep model

Articular resurfacing metal implants have recently been tested in animal models to treat full thickness localized articular cartilage defects, showing promising results. However, the mechanical behavior of cartilage surrounding the metal implant has not been studied yet as it is technically challenging to measure in vivo contact areas, pressures, stresses and deformations from the metal implant. Therefore, we implemented a detailed numerical finite element model by approximating one of the condyles of the sheep tibiofemoral joint and created a defect of specific size to accommodate the implant. Using this model, the mechanical behavior of the surrounding of metal implant was studied. The model showed that the metal implant plays a significant role in the force transmission. Two types of profiles were investigated for metal implant. An implant with a double-curved profile, i.e., a profile fully congruent with the articular surfaces in the knee, gives lower contact pressures and stresses at the rim of the defect than the implant with unicurved spherical profile. The implant should be placed at a certain distance into the cartilage to avoid damage to opposing biological surface. Too deep positions, however, lead to high shear stresses in the cartilage edges around the implant. Mechanical sealing was achieved with a wedge shape of the implant, also useful for biochemical sealing of cartilage edges at the defect.     

Wear-induced loss of mass in reversed total shoulder arthroplasty with conventional and inverted bearing materials

The notching phenomenon is one of the major concerns with reversed total shoulder arthroplasty. Repetitive contact between the humeral implant and the scapula (mechanical notching) produces progressive abrasion of the implant if the moving part is made of polyethylene. Its debris may then lead to active osteolysis (biological notching). Inversion of bearing materials, i.e. Glenosphere made of polyethylene and humeral Inlay made of metal, aims at the reduction of this phenomenon. However, the question arises if the tribological behavior would then be different. On an experimental setup, the gravimetric wear of both material configurations was measured after loading and moving over 500,000 cycles. The abrasion of the polyethylene Inlay due to mechanical notching was calculated by means of 3D CAD models with different notching stages. The loss of mass due to gravimetric wear was compared to the loss of mass caused by mechanical notching. After 500,000 cycles the measured amount of wear of the polyethylene components was between 8 and 10 mg for both tribological pairings. The calculated loss of mass of the polyethylene Inlay caused by mechanical notching ranged from 73 to 3881 mg. The results of this study indicate that the gravimetric polyethylene wear in the estimated life-time is very low and not significantly different between both material configurations. However, the polyethylene abrasion due to mechanical notching in the configuration with polyethylene Inlay is by far more important than any gravimetric wear. These results support the continued use of inverted bearings in reversed total shoulder arthroplasty.     

A finite element model of the L4-L5 spinal motion segment: biomechanical compatibility of an interspinous device

The biomechanical compatibility of an interspinous device, used for the "dynamic stabilization" of a diseased spinal motion segment, was investigated. The behaviour of an implant made of titanium based alloy (Ti6Al4V) and that of an implant made of a super-elastic alloy (Ni-Ti) have been compared. The assessment of the biomechanical compatibility was achieved by means of the finite element method, in which suitable constitutive laws have been adopted for the annulus fibrosus and for the metal alloys. The model was aimed at simulating the healthy, the nucleotomized and the treated L4-L5 lumbar segment, subjected to compressive force and flexion-extension as well as lateral flexion moments. The computational model has shown that both the implants were able to achieve their main design purpose, which is to diminish the forces acting on the apophyseal joints. Nevertheless, the Ni-Ti implant has shown a more physiological flexural stiffness with respect to the Ti6Al4V implant, which exhibited an excessive stiffness and permanent strains (plastic strains), even under physiological loads. The computational models presented in this paper seems to be a promising tool able to predict the effectiveness of a biomedical device and to select the materials to be used for the implant manufacturing, within an engineering approach to the clinical problem of the spinal diseases.     

Metal ion release barrier function and biotribological evaluation of a zirconium nitride multilayer coated knee implant under highly demanding activities wear simulation

Total knee arthroplasty is a well established treatment for degenerative joint disease, which is also performed as a treatment in younger and middle-aged patients who have a significant physical activity and high life expectancy. However, complications may occur due to biological responses to wear particles, as well as local and systemic hypersensitivity reactions triggered by metal ions and particles such as cobalt, chromium and molybdenum. The purpose of the study was to perform a highly demanding activities (HDA) knee wear simulation in order to compare the wear characteristics and metal ion release barrier function of a zirconium nitride (ZrN) coated knee implant, designed for patients with suspected metal ion hypersensitivity, against an uncoated knee implant made out of CoCrMo. The load profiles were applied for 5 million HDA cycles, which represent 15–30 years of in vivo service depending on the activity level of the patient. Results showed a significant wear rate reduction for the coated group (1.01 ± 0.29 mg/million cycles) in comparison with the uncoated group (2.89 ± 1.04 mg/million cycles). The zirconium nitride coating showed no sign of scratches nor delamination during the wear simulation, whereas the uncoated femurs showed characteristic wear scratches in the articulation areas. Furthermore, the metal ion release from the coated implants was reduced up to three orders of magnitude in comparison with the uncoated implants. These results demonstrate the efficiency of zirconium nitride coated knee implants to reduce wear as well as to substantially reduce metal ion release in the knee joint.     

A holistic numerical model to predict strain hardening and damage of UHMWPE under multiple total knee replacement kinematics and experimental validation

Experimental wear testing is an essential step in the evaluation of total knee replacement (TKR) design. Unfortunately, experiments can be prohibitively expensive and time consuming, which has made computational wear simulation a more desirable alternative for screening designs. While previous attempts have demonstrated positive results, few models have fully incorporated the affect of strain hardening (or cross shear), or tested the model under more than one loading condition. The objective of this study was to develop and evaluate the performance of a new holistic TKR damage model, capable of predicting damage caused by wear, including the effects of strain hardening and creep. For the first time, a frictional work-based damage model was compared against multiple sets of experimental TKR wear testing data using different input kinematics. The wear model was tuned using experimental measurements and was then able to accurately predict the volumetric polyethylene wear volume during experiments with different kinematic inputs. The size and shape of the damage patch on the surface of the polyethylene inserts were also accurately predicted under multiple input kinematics. The ability of this model to predict implant damage under multiple loading profiles by accounting for strain hardening makes it ideal for screening new implant designs, since implant kinematics are largely a function of the shape of the components.     

Corrosion behaviour, metal release and biocompatibility of implant materials coated by TiO2-sol gel chemistry]

Alloys based on titanium or cobalt have been used as implant materials for decades with good success. Because of their natural oxide layer these alloys reveal good corrosion behaviour. In contact with physiological solution metal release takes place, which can cause inflammation. Coatings can improve the corrosion behaviour. In this study Ti6Al4V and Co28Cr6Mo alloys, which are frequently used as implant materials, were tested. Polished discs of these alloys and polished discs, which were coated with TiO2-layers by sol-gel chemistry, were compared regarding their corrosion behaviour and metal ion releasing. The releasing of Al, V, Ti, Co, Cr and Mo was quantified by ICP-MS analysis. The TiO2-coating reduced the release of all ions except of the Al-ion. Both alloys showed a deviating kinetic of ion releasing. In addition, cell response (cell vitality, cell proliferation, endothelial marker CD31 and actin allocation) of osteoblasts and endothelial cells were investigated.     

Mesoporous TiO2 nanoparticles: A new material for biolistic bombardment

To date, only solid heavy metals such as gold or tungsten have been used as DNA carriers in biolistic bombardment of algae. In this study, we show that even a metal oxide of lower density can act as a DNA carrier. We investigated the potency of size‐controlled mesoporous titanium dioxide (TiO₂) particles. Among the six tested gas pressures, TiO₂ particles best facilitated transformation of the green alga Chlamydomonas reinhardtii at 1100 psi (approximately 7.6 MPa) and 2000 psi (approximately 14 MPa). Surprisingly, a mesoporous metal oxide with a density of approximately only one‐tenth that of gold or tungsten could be effective as a DNA carrier in biolistic bombardment of a rigid cell wall‐containing alga. In addition, we found two peaks of gas pressures in the transformation ratio irrespective of whether the particles were made of gold, tungsten, or TiO₂.     

Blood and plasma titanium levels associated with well-functioning hip implants

BackgroundHip implants are usually manufactured from cobalt-chromium and titanium alloys. As the implants wear and corrode, metal debris is released into the surrounding tissue and blood, providing a potential biomarker for their function. Whilst there are laboratory reference levels for blood cobalt and chromium in patients with well and poorly functioning hip implants, there are no such guidelines for titanium. This is despite the increasing use of titanium implants worldwide.Patients and methodsWe recruited a consecutive series of 95 patients (mean age 71 years, mean time after surgery 8.5 years) with one hip implant type, inserted by the same surgeon. We assessed clinical and radiological outcome, and measured blood and plasma titanium using high resolution inductively-coupled plasma mass spectrometry.ResultsThe upper normal reference limit for blood and plasma titanium was 2.20 and 2.56 μg L⁻¹, respectively, and did not differ significantly between males and females.ConclusionWe are the first to propose a laboratory reference level for blood and plasma titanium in patients with well-functioning titanium hip implants. This is an essential starting point for further studies to explore the clinical usefulness of blood titanium as a biomarker of orthopaedic implant performance, and comes at a time of considerable controversy regarding the use of certain titanium alloys in hip arthroplasty.     

Radiographic inspection of porosity in pure titanium dumbbell castings

Radiographic inspection of porosity in pure titanium dumbbell castings Background: Titanium frameworks are frequently indicated for implant supported prostheses; however, voids are usually encountered inside cast titanium. Objective: This study aimed to confirm the efficacy of a radiographic technique for inspection of porosity in commercially pure titanium castings with different diameter. Materials and methods: Sixty dumbbell rods (n = 20) with a central 1.5, 2.0 and 3.5 mm diameter were prepared by lost‐wax casting. Cast specimens were finished and polished and submitted to radiographic examination (90 kV, 15 mA, 0.6 s and 10–13 mm of distance) using periapical film. The radiographs were visually analysed for the presence of porosity in the extension of the dumbbell or in the central portion of the rods. Data were submitted to Pearson Chi‐square test (5%). Results: The tested radiographic method proved to be suitable for the evaluation of cast frameworks. Internal porosities were observed in most of the specimens (91.7%) (p = 0.0005); however, only 20% occurred on the central portion of the rods (p = 0.612). Conclusion: Internal porosities can be visualised through radiographs and occur mostly in small diameter structures. The radiographic evaluation of metal structures can improve the quality of frameworks and thereby potentially increase the longevity of the rehabilitation.     

Finite element analysis of a cemented ceramic femoral component for the assembly situation in total knee arthroplasty]

The femoral components of the total knee replacements are generally made of metal. In contrast, ceramic femoral components promise improved tribological and allergological properties. However, ceramic components present a risk of failure as a result of stress peaks. Stress peaks can be minimised through adequate implant design, proper material composition and optimum force transmission between bone and implant. Thus, the quality of the implant fixation is a crucial factor. The objective of the present study was to analyse the influence of the cement layer thickness on stress states in the ceramic femoral component and in the femur. Two- and three- dimensional finite element analyses of an artificial knee joint with cement layers of different thickness and with an unbalanced cement layer thickness between the ceramic femoral component and the femur were performed. Higher stress regions occurred in the area of force transmission and in the median plane. The maximum calculated stresses were below the accepted tensile strength. Stresses were found to be lower for cement layer thickness of <2.0 mm.     

Mandibular matrix implant system: a method to restore skeletal support to the lower face

Disharmony between the skeletal support and the softtissue envelope is a common cause of aesthetic concerns regarding the lower face. A loss of volume or a genetically small mandible affects the aesthetics and function of the mouth, chin, and neck. Because of the limitations of correcting such problems with current implants made of silicone or porous polyethylene, the author developed an implant system and a method of restoring the entire volume of the mandible called the mandibular matrix implant system. This implant system is made of high-density porous polyethylene and is composed of an articulated wraparound geniomandibular implant and a wraparound gonial angle implant. A prejowl implant can be integrated in the system as an addition or as a replacement for a chin implant. This implant system has different sizes and projections, and it can be modified by carving to fit the requirements of most patients. Carving is done using an appropriate sizer. This implant system is indicated for use in patients with a congenitally small mandible, edentulous patients, and patients requesting facial enhancement. The mandibular matrix implant system is implanted either during a single procedure or simultaneously with a facial rejuvenation. The extended geniomandibular implant is introduced through an anterior oral sulcus incision or a submental incision. The mandibular angle implant is introduced through a retromolar incision. The posterior end of the chin implant overlaps the anterior end of the gonial implant, and screw fixation of each chin component helps to stabilize the entire system. Antibiotics, irrigation, and closure of the incisions are performed before any additional operative procedure. The complete system has been used in 13 patients; one additional patient had the complete system plus an overlapping additional left prejowl implant for correction of asymmetry. Complications were manageable; these included one mandibular angle implant displacement and one infection. The implant displacement required a reoperation to reset the implant. The infection was treated with irrigation and closed system suction; the implant was salvaged. The satisfaction of patients has been high, and the author can now solve aesthetic problems that in the past were considered unsolvable.     

Techniques for Processing Eyes Implanted with a Retinal Prosthesis for Localized Histopathological Analysis: Part 2 Epiretinal Implants with Retinal Tacks

Retinal prostheses for the treatment of certain forms of blindness are gaining traction in clinical trials around the world with commercial devices currently entering the market. In order to evaluate the safety of these devices, in preclinical studies, reliable techniques are needed. However, the hard metal components utilised in some retinal implants are not compatible with traditional histological processes, particularly in consideration for the delicate nature of the surrounding tissue. Here we describe techniques for assessing the health of the eye directly adjacent to a retinal implant secured epiretinally with a metal tack.Retinal prostheses feature electrode arrays in contact with eye tissue. The most commonly used location for implantation is the epiretinal location (posterior chamber of the eye), where the implant is secured to the retina with a metal tack that penetrates all the layers of the eye. Previous methods have not been able to assess the proximal ocular tissue with the tack in situ, due to the inability of traditional histological techniques to cut metal objects. Consequently, it has been difficult to assess localized damage, if present, caused by tack insertion.Therefore, we developed a technique for visualizing the tissue around a retinal tack and implant. We have modified an established technique, used for processing and visualizing hard bony tissue around a cochlear implant, for the soft delicate tissues of the eye. We orientated and embedded the fixed eye tissue, including the implant and retinal tack, in epoxy resin, to stabilise and protect the structure of the sample. Embedded samples were then ground, polished, stained, and imaged under various magnifications at incremental depths through the sample. This technique allowed the reliable assessment of eye tissue integrity and cytoarchitecture adjacent to the metal tack.     

Breast augmentation: choosing the optimal incision, implant, and pocket plane

A retrospective study of 220 patients was performed to review surgical design in breast augmentation. Three specific issues were studied: incision site, implant variables, and pocket plane selection. The influence of these three factors on aesthetic results in both primary and secondary cases was the focus of the analysis. No attempt was made to address long-term issues such as capsular contracture or saline implant deflation rates. In 77 primary augmentation patients and 80 unilateral augmentations for symmetry in breast reconstruction, there were the following untoward results: 11 revisions for unilateral malposition, change to a different implant shape, or change to a larger implant size; four deflations of saline implants requiring replacement; and four conversions of saline to silicone gel implants. In 63 secondary cases, there were two hematomas and two infections requiring implant removal and subsequent replacement. Operative technique in breast augmentation is described, as are recommendations for each of the options associated with the three variables studied.     

Nano rough micron patterned titanium for directing osteoblast morphology and adhesion

Previous studies have demonstrated greater functions ofosteoblasts (bone-forming cells) on nanophase compared with conventional metals. Nanophase metals possess a biologically inspired nanostructured surface that mimics the dimensions of constituent components in bone, including collagen and hydroxyapatite. Not only do these components possess dimensions on the nanoscale, they are aligned in a parallel manner creating a defined orientation in bone. To date, research has yet to evaluate the effect that organized nanosurface features can have on the interaction of osteoblasts with material surfaces. Therefore, to determine if surface orientation of features can mediate osteoblast adhesion and morphology, this study investigated osteoblast function on patterned titanium substrates containing alternating regions of micron rough and nano rough surfaces prepared by novel electron beam evaporation techniques. This study was also interested in determining whether or not the size of the patterned regions had an effect on osteoblast behavior and alignment. Results indicated early controlled osteoblast alignment on these patterned materials as well as greater osteoblast adhesion on the nano rough regions of these patterned substrates. Interestingly, decreasing the width of the nano rough regions (from 80 microm to 22 microm) on these patterned substrates resulted in a decreased number of osteoblasts adhering to these areas. Changes in the width of the nano rough regions also resulted in changes in osteoblast morphology, thus, suggesting there is an optimal pattern dimension that osteoblasts prefer. In summary, results of this study provided evidence that aligned nanophase metal features on the surface of titanium improved early osteoblast functions (morphology and adhesion) promising for their long term functions, criteria necessary to improve orthopedic implant efficacy.