Calcium phosphate cement augmentation of cancellous bone screws can compensate for the absence of cortical fixation

An obvious means to improve the fixation of a cancellous bone screw is to augment the surrounding bone with cement. Previous studies have shown that bone augmentation with Calcium Phosphate (CaP) cement significantly improves screw fixation. Nevertheless, quantitative data about the optimal distribution of CaP cement is not available. The present study aims to show the effect of cement distribution on the screw fixation strength for various cortical thicknesses and to determine the conditions at which cement augmentation can compensate for the absence of cortical fixation in osteoporotic bone. In this study, artificial bone materials were used to mimic osteoporotic cancellous bone and cortical bone of varying thickness. These bone constructs were used to test the fixation strength of cancellous bone screws in different cortical thicknesses and different cement augmentation depths. The cement distribution was measured with microCT. The maximum pullout force was measured experimentally. The microCT analysis revealed a pseudo-conic shape distribution of the cement around the screws. While the maximum pullout strength of the screws in the artificial bone only was 30±7 N, it could increase up to approximately 1000 N under optimal conditions. Cement augmentation significantly increased pullout force in all cases. The effect of cortical thickness on pullout force was reduced with increased cement augmentation depth. Indeed, cement augmentation without cortical fixation increased pullout forces over that of screws without cement augmentation but with cortical fixation. Since cement augmentation significantly increased pullout force in all cases, we conclude that the loss of cortical fixation can be compensated by cement augmentation.     

A Biomechanical Comparison of Expansive Pedicle Screws for Severe Osteoporosis: The Effects of Screw Design and Cement Augmentation

Expansive pedicle screws significantly improve fixation strength in osteoporotic spines. However, the previous literature does not adequately address the effects of the number of lengthwise slits and the extent of screw expansion on the strength of the bone/screw interface when expansive screws are used with or without cement augmentation. Herein, four designs for expansive pedicle screws with different numbers of lengthwise slits and different screw expansion levels were evaluated. Synthetic bones simulating severe osteoporosis were used to provide a comparative platform for each screw design. The prepared specimens were then tested for axial pullout failure. Regardless of screw design, screws with cement augmentation demonstrated significantly higher pullout strength than pedicle screws without cement augmentation (p < 0.001). For screws without cement augmentation, solid screws exhibited the lowest pullout strength compared to the four expansive groups (p < 0.01). No significant differences in pullout strength were observed between the expansive screws with different designs (p > 0.05). Taken together, our results show that pedicle screws combined with cement augmentation may greatly increase screw fixation regardless of screws with or without expansion. An increase in both the number of slits and the extent of screw expansion had little impact on the screw-anchoring strength. Cement augmentation is the most influential factor for improving screw pullout strength.     

Effect of pedicle screw diameter on screw fixation efficacy in human osteoporotic thoracic vertebrae

The selection of an ideal screw size plays a crucial role in the success of spinal instrumentation as larger diameter screws are thought to provide better fixation strength but increase the risk of pedicle failure during insertion. On the other hand, smaller diameter screws are with lesser risk of pedicle breakage but are thought to compromise the stability of the instrumentation. By investigating the relationship between screw diameter and the pullout strength of pedicle screws after fatigue loading, this study seeks to find quantitative biomechanical data for surgeons in determining the most ideal diameter size screws when performing surgical implementations on osteoporotic vertebrae.Twenty-seven osteoporotic (BMD ranged: 0.353–0.848 g/cm²) thoracic vertebrae (T3-T8) were harvested from 5 human cadavers. Two sizes of poly-axial screws (5.0 mm × 35 and 4.35 mm × 35) were implanted into each pedicles of the vertebrae by an experienced surgeon. Specimens were randomly distributed into control group, fatigue group of 5000 and 10,000 cycles with peak-to-peak loadings of 10–100 N at 1 Hz. Each specimen was then axial pullout tested at a constant rate of 5 mm/min. The ultimate pullout strength (N) & stiffness (N/mm) were obtained for analysis.The results showed that although the larger diameter screws achieved superior pullout strength immediately after the implantation, both sizes of screws exhibited comparable pullout strengths post fatigue loading. This indicates that the smaller diameter screws may be considered for surgical techniques performed on osteoporotic vertebrae for reduced risk of pedicle breakage without sacrificing fixation strength.     

Injectable calcium phosphate cement for augmentation around cancellous bone screws. In vivo biomechanical studies

In lower cancellous apparent bone density, it can be difficult to achieve adequate screw fixation and hence stable fracture fixation. Different strategies have been proposed, one of them is through augmentation using calcium phosphate cement in the region at or close to the screw thread itself. To support the hypothesis of an improved screw fixation technique by augmentation of the bone surrounding the implanted screw, in vivo biomechanical and densitometric studies are performed on rabbit specimen where normal and simulated weak bone quality are considered. In particular, the evolution of screw stability till 12 weeks following the implantation is quantified. A statistical significance in the pull out force for augmented versus non-augmented screws was found for the shorter time periods tested of ≤ 5 days whilst the pull out force was found to increase with time for both augmented and non-augmented screws during the 12 week course of the study. The results of the study demonstrate that the use of an injectable calcium phosphate cement which sets in vivo can significantly improve screw pull out strength at and after implantation for normal and simulated weak bone quality.     

An approximate model for cancellous bone screw fixation

This paper presents a finite element (FE) model to identify parameters that affect the performance of an improved cancellous bone screw fixation technique, and hence potentially improve fracture treatment. In cancellous bone of low apparent density, it can be difficult to achieve adequate screw fixation and hence provide stable fracture fixation that enables bone healing. Data from predictive FE models indicate that cements can have a significant potential to improve screw holding power in cancellous bone. These FE models are used to demonstrate the key parameters that determine pull-out strength in a variety of screw, bone and cement set-ups, and to compare the effectiveness of different configurations. The paper concludes that significant advantages, up to an order of magnitude, in screw pull-out strength in cancellous bone might be gained by the appropriate use of a currently approved calcium phosphate cement.     

Biomechanical measurements on scaphoid bone screws in an experimental model

A number of screws commonly used for internal fixation in scaphoid bone fractures and nonunions are compared regarding biomechanical properties and clinical applicability. The experiments were carried out on models made of ash-wood, representing a reconstruction and fixation as is performed in a cortico-cancellous inlay bone graft for scaphoid non-union. For fixation use was made of 2.7 and 3.5 AO/ASIF cortical screws respectively, 4.0 AO/ASIF cancellous screws, Herbert screws, and a newly designed screw called the three components screw (D.K.S.). The models with implanted screws were tested for bending strength, tensile strength and torsion stability. No large differences between the various screws were found regarding the measured parameters, so that a small intra-osteal implant such as the Herbert screw and the D.K.S., which can be inserted easily and which gives a certain amount of interfragmentary compression, will be sufficient for osteosynthesis of the scaphoid bone. In case an intra-osteal implant is not available a single 3.5 AO/ASIF cortical screw, inserted following lag-screw principles, is recommended.     

Anterior vertebral body screw pullout testing with the hollow modular anchorage system--a comparative in vitro study.

Pullout of implants at the proximal and distal ends of multilevel constructs represents a common spinal surgery problem. One goal concerning the development of new spinal implants is to achieve stable fixation together with the least invasive approach to the spinal column. This biomechanical study measures the influence of different modes of implantation and different screw designs, including a new monocortical system, on the maximum pullout strength of screws inserted ventrolaterally into calf vertebrae. The force pullout of eight different groups were tested and compared. Included were three bicortical used single screws (USS, Zielke-VDS, single KASS). To further increase pullout strength either a second screw (KASS) or a pullout-resistant nut can be added (USS with pullout nut). A completely new concept of anchorage represents the Hollow Modular Anchorage System (MACS-HMA). This hollow titanium implant has an increased outside diameter and is designed for monocortical use. Additionally two screw systems suitable for bicortical use were tested in monocortical mode of anchorage (USS, single KASS). We selected seven vertebrae equal in mean size and bone mineral density for each of the eight groups. The vertebral body and implant were connected to both ends of a servohydraulic testing machine. Displacement controlled distraction was applied until failure at the metal-bone-interface occurred. The maximum axial pullout force was recorded. Mean BMD was 312 +/- 55 mg CaHA/ml in cancellous bone and 498 +/- 98 mg CaHA/ml in cortical bone. The highest resistance to pullout found, measured 4.2 kN (KASS) and 4.0 kN (USS with pullout nut). The mean pullout strength of Zielke-VDS was 2.1 kN, of single KASS 2.5 kN, of MACS-HMA 2.6 kN and of USS 3.2 kN. There was no statistically significant difference (t-test, p > 0.05) between bicortical screws and the new monocortical implant. For the strongest fixation at the proximal or distal end of long spinal constructs the addition of a second screw or a pullout-resistant nut behind the opposite cortex offers even stronger fixation.     

Material changes in osteoporotic human cancellous bone following infiltration with acrylic bone cement for a vertebral cement augmentation

Bone cement infiltration can be effective at mechanically augmenting osteoporotic vertebrae. While most published literature describes the gain in mechanical strength of augmented vertebrae, we report the first measurements of viscoelastic material changes of cancellous bone due to cement infiltration. We infiltrated cancellous core specimen harvested from osteoporotic cadaveric spines with acrylic bone cement. Bone specimen before and after cement infiltration were subjected to identical quasi-static and relaxation loading in confined and free compression. Testing data were fitted to a linear viscoelastic model of compressible material and the model parameters for cement, native cancellous bone, and cancellous bone infiltrated (composite) with cement were identified. The fitting demonstrated that the linear viscoelastic model presented in this paper accurately describes the mechanical behaviour of cement and bone, before and after infiltration. Although the composite specimen did not completely adopt the properties of bulk bone cement, the stiffening of cancellous bone due to cement infiltration is considerable. The composite was, for example, 8.5 times stiffer than native bone. The local stiffening of cancellous bone in patients may alter the load transfer of the augmented motion segment and may be the cause of subsequent fractures in the vertebrae adjacent to the ones infiltrated with cement. The material model and parameters in this paper, together with an adequate finite-element model, can be helpful to investigate the load shift, the mechanism for subsequent fractures, and filling patterns for ideal cement infiltration.     

Cortical screw pullout strength and effective shear stress in synthetic third generation composite femurs

BACKGROUND: The use of artificial bone analogs in biomechanical testing of orthopaedic fracture fixation devices has increased, particularly due to the recent development of commercially available femurs such as the third generation composite femur that closely reproduce the bulk mechanical behavior of human cadaveric and/or fresh whole bone. The purpose of this investigation was to measure bone screw pullout forces in composite femurs and determine whether results are comparable to cadaver data from previous literature. METHOD OF APPROACH: The pullout strengths of 3.5 and 4.5 mm standard bicortical screws inserted into synthetic third generation composite femurs were measured and compared to existing adult human cadaveric and animal data from the literature. RESULTS: For 3.5 mm screws, the measured extraction shear stress in synthetic femurs (23.70-33.99 MPa) was in the range of adult human femurs and tibias (24.4-38.8 MPa). For 4.5 mm screws, the measured values in synthetic femurs (26.04-34.76 MPa) were also similar to adult human specimens (15.9-38.9 MPa). Synthetic femur results for extraction stress showed no statistically significant site-to-site effect for 3.5 and 4.5 mm screws, with one exception. Overall, the 4.5 mm screws showed statistically higher stress required for extraction than 3.5 mm screws. CONCLUSIONS: The third generation composite femurs provide a satisfactory biomechanical analog to human long-bones at the screw-bone interface. However, it is not known whether these femurs perform similarly to human bone during physiological screw "toggling."     

齿状突几何参数、骨密度与生物力学性质的相关性研究

目的:齿状突骨折是颈椎的严重损伤,其中大部分需要行前路螺钉内固定术治疗,齿状突的几何参数对螺钉的选择起决定性作用,其骨密度则影响螺钉对骨质的把持力,齿状突固有的生物力学性质对齿状突骨折固定效果进而对骨折愈合有较大影响,基于以上考虑,本课题分析并比较了几何参数、骨密度与生物力学性质的相关性,评价其指导临床应用的意义。方法:将15例经福尔马林浸泡的国人枢椎标本剔除周围软组织,分别测量并分析各个标本的几何参数、骨密度以及扭转刚度、剪切刚度、拉伸刚度等生物力学性质的特点,并比较它们之间的相关性。结果:齿状突为一椭球形结构,难以容纳两枚内固定螺钉,齿状突的几何参数、骨密度和生物力学性质之间没有相关性。结论:临床上在对齿状突骨折采用螺钉内固定前需要了解齿状突的解剖结构并据此选取适当尺寸的螺钉,应根据齿状突基底部的横径选择螺钉的直径,根据基底部到前唇的距离选择螺钉光滑段的长度,根据枢椎高度选择螺钉长度,齿状突的几何参数、骨密度和齿状突的生物力学性质之间并无相关性,并不能根据齿状突几何参数、骨密度来预测其生物力学强度进而预测内固定的初始稳定性。     

Material Changes in Osteoporotic Human Cancellous Bone Following Infiltration with Acrylic Bone Cement for a Vertebral Cement Augmentation

Bone cement infiltration can be effective at mechanically augmenting osteoporotic vertebrae. While most published literature describes the gain in mechanical strength of augmented vertebrae, we report the first measurements of viscoelastic material changes of cancellous bone due to cement infiltration. We infiltrated cancellous core specimen harvested from osteoporotic cadaveric spines with acrylic bone cement. Bone specimen before and after cement infiltration were subjected to identical quasi-static and relaxation loading in confined and free compression. Testing data were fitted to a linear viscoelastic model of compressible material and the model parameters for cement, native cancellous bone, and cancellous bone infiltrated (composite) with cement were identified. The fitting demonstrated that the linear viscoelastic model presented in this paper accurately describes the mechanical behaviour of cement and bone, before and after infiltration. Although the composite specimen did not completely adopt the properties of bulk bone cement, the stiffening of cancellous bone due to cement infiltration is considerable. The composite was, for example, 8.5 times stiffer than native bone. The local stiffening of cancellous bone in patients may alter the load transfer of the augmented motion segment and may be the cause of subsequent fractures in the vertebrae adjacent to the ones infiltrated with cement. The material model and parameters in this paper, together with an adequate finite-element model, can be helpful to investigate the load shift, the mechanism for subsequent fractures, and filling patterns for ideal cement infiltration.     

Cortical bone failure mechanisms during screw pullout

An experimental and computational study of screw pullout from cortical bone has been conducted. A novel modification of standard pullout tests providing real time image capture of damage mechanisms during screw pullout was developed. Pullout forces, measured using the novel test rig, have been validated against standard pullout tests. Pullout tests were conducted, considering osteon alignment, to investigate the effect of osteons aligned parallel to the axis of the orthopaedic screw (longitudinal pullout) as well as the effect of osteons aligned perpendicular to the axis of the screw (transverse pullout). Distinctive alternate failure mechanisms, for longitudinally and transversely orientated cortical bone during screw pullout, were uncovered. Vertical crack propagation, parallel to the axis of the screw, was observed for a longitudinal pullout. Horizontal crack propagation, perpendicular to the axis of the screw, was observed for a transverse pullout. Finite element simulation of screw pullout, incorporating material damage and crack propagation, was also performed. Simulations revealed that a homogenous material model for cortical bone predicts vertical crack propagation patterns for both longitudinal and transverse screw pullout. A bi-layered composite model representing cortical bone microstructure was developed. A unique set of material and damage properties was used for both transverse and longitudinal pullout simulations, with only layer orientations being changed. Simulations predicted: (i) higher pullout forces for transverse pullout; (ii) horizontal crack paths perpendicular to screw axis for transverse pullout, whereas vertical crack paths were computed for longitudinal pullout. Computed results agreed closely with experimental observations in terms of pullout force and crack propagation.     

Design and testing of external fixator bone screws

In external fixation, bone screw loosening still presents a major clinical problem. For this study, the design factors influencing the mechanics of the bone-screw interface were analysed and various experimental screws designed with the intention of maximizing the strength and stiffness of the inserted screw. Push-in, pull-out and bending tests were then carried out on the three experimental screws, and on two commercially available screws in both a synthetic material and in cadaveric bone; photoelastic tests on different screw threadforms were also performed. The results of the push-in and pull-out tests indicate that both the screw threadform and cutting head have a significant effect on the holding strength of the screw. The photoelastic tests show that most of the applied load is distributed over the first few threads closest to the load, and that the area between the thread crests is subjected to high shear stresses.     

A Particle Model for Prediction of Cement Infiltration of Cancellous Bone in Osteoporotic Bone Augmentation

Femoroplasty is a potential preventive treatment for osteoporotic hip fractures. It involves augmenting mechanical properties of the femur by injecting Polymethylmethacrylate (PMMA) bone cement. To reduce the risks involved and maximize the outcome, however, the procedure needs to be carefully planned and executed. An important part of the planning system is predicting infiltration of cement into the porous medium of cancellous bone. We used the method of Smoothed Particle Hydrodynamics (SPH) to model the flow of PMMA inside porous media. We modified the standard formulation of SPH to incorporate the extreme viscosities associated with bone cement. Darcy creeping flow of fluids through isotropic porous media was simulated and the results were compared with those reported in the literature. Further validation involved injecting PMMA cement inside porous foam blocks — osteoporotic cancellous bone surrogates — and simulating the injections using our proposed SPH model. Millimeter accuracy was obtained in comparing the simulated and actual cement shapes. Also, strong correlations were found between the simulated and the experimental data of spreading distance (R² = 0.86) and normalized pressure (R² = 0.90). Results suggest that the proposed model is suitable for use in an osteoporotic femoral augmentation planning framework.     

Effect of screw position on load transfer in lumbar pedicle screws: a non-idealized finite element analysis

Angled screw insertion has been advocated to enhance fixation strength during posterior spine fixation. Stresses on a pedicle screw and surrounding vertebral bone with different screw angles were studied by finite element analysis during simulated multidirectional loading. Correlations between screw-specific vertebral geometric parameters and stresses were studied. Angulations in both the sagittal and axial planes affected stresses on the cortical and cancellous bones and the screw. Pedicle screws pointing laterally (vs. straight or medially) in the axial plane during superior screw angulation may be advantageous in terms of reducing the risk of both screw loosening and screw breakage.     

Pullout performance of self-tapping medical screws

This study investigates the effect of the pilot hole size, implant depth, synthetic bone density, and screw size on the pullout strength of the self-tapping screw using analytical, finite element, and experimental methodologies. Stress distribution and failure propagation mode around the implant thread zone are also investigated. Based on the finite element analysis (FEA) results, an analytical model for the pullout strength of the self-tapping screw is constructed in terms of the (synthetic) bone mechanical properties, screw size, and the implant depth. The pullout performance of self-tapping screws is discussed. Results from the analytical and finite element models are experimentally validated.     

骨水泥填充治疗桡骨远端骨质疏松骨折

目的:探讨骨水泥填充治疗桡骨远端骨质疏松骨折的方法。方法:对本科2000以来对8例桡骨远端骨质疏松骨行有限切开、关节面撬拨复位后注入骨水泥填充关节软骨下缺损治疗。结果:全部病例获得随访10-68月,平均22月。所有患者术后1周内肿胀消失,3～4周功能恢复接近正常。X线检查显示骨折愈合良好,无延迟愈合或不愈合。患者自我感觉5例表示满意,2例表示基本满意,1例表示不满意,满意率87.5%。结论:有限切开、关节面撬拨复位后注入骨水泥填充关节软骨下缺损是治疗桡骨远端骨质疏松骨折的有效方法。     

Tensile strength of bone fixation of hydroxyapatite coated Schanz screws of the Heidelberg External Fixation System (HEFS)--comparative torque measurements in clinical use and in cadaver tibia]

It is claimed in the literature that hydroxyapatite(HA)-coated screws of external fixators have superior fixation strength in bone, which is postulated to lead to a substantial decrease in loosening and infection rates. We report on a study of the maximum torque values developed while inserting and removing 30 HA-coated Schanz screws of 8 Heidelberg external fixation systems applied to the tibia to correct leg length differences and axial deformities. The infection rate was determined in accordance with defined criteria, and was found to be about 20% for the HA-coated screws. Screws without infection showed an extraction torque above insertion torque, screws with infection an extraction torque below. A significant correlation (p = 0.05) was seen between infection and decrease in fixation strength (quotient: loosening torque/tightening torque). To exclude the impact of such biological processes as osteointegration and bone remodelling, the clinical results were compared with the torques measured for coated and uncoated Schanz screws in a human cadaveric tibia. A significantly higher fixation strength in bone was found for HA-coated screws in comparison with uncoated screws (p = 0.002). These data warrant a clinical study directly comparing HA-coated and uncoated Schanz screws.     

Central screw use delays implant dislodgement in osteopenic bone but not synthetic surrogates: A comparison of reverse total shoulder models

Adequate glenoid baseplate fixation in reverse total shoulder arthroplasty (rTSA) is important to achieve, but may prove challenging in the context of glenoid bone loss or osteopenia. Current rTSA testing standards rely upon synthetic bone surrogates, but it is unclear if these models accurately recapitulate the mechanics of osteoporotic bone. Additionally, it also unknown if the use of a central screw effectively provides resistance to micromotion in the milieu of poor quality bone. The purpose of this experiment was to create a novel cyclic load test protocol that elicited clinically relevant failures, so that comparisons of relative motion between baseplates and bones could be made with: (1) synthetic bones and poor quality cadaveric bones, and (2) the use or omission of a central screw. rTSA components were implanted into cadaveric and synthetic bones with and without a central screw. To model a range of loads that may be experienced during abduction, increasing cyclic loads were applied to shoulder joints in 30° of humeral abduction. Cycles and loads prior to permanent deformation exceeding 150 µm, 1 mm, and joint failure were determined using measurements from the test frame and from 3-D motion analysis. Synthetic bones demonstrated significantly more resistance to micromotion in comparison to cadaveric bones. Use of the central screw improved resistance to dislodgement, which was only observed in the cadaveric specimens. This study highlights the need for biomechanical testing with cadaveric specimens, especially when assessing osteopenic or osteoporotic populations.     

Stress analysis of a centrally fractured rib fixated by an intramedullary screw

The stress on an intramedullary screw rib fixation device holding together a centrally fractured human rib under in vivo force loadings was studied using finite element analysis (FEA). Validation of the FEA modelling using pullout from porcine ribs proved FEA to be suitable for assessing the structural integrity of screw/bone systems such as rib fixated by a screw. In the human rib fixation investigation, it was found that intramedullary bioresorbable Bioretec screws can fixate centrally fractured human ribs under normal breathing conditions. However, under coughing conditions, simulation showed Bioretec fixating screws to bend substantially. High stresses in the screw are mainly the result of flexion induced by the force loading, and are restricted to thin regions on the outside of the screw shaft. Stiffer screws result in less locally intense stress concentrations in bone, indicating that bone failure in the bone/screw contact regions can be averted with improvements in screw stiffness.