Article

Effect of anatomical variability on stress‐shielding induced by short calcar‐guided stems: Automated finite element analysis of 90 femora

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Short stem hip implants are becoming increasingly popular since they preserve bone stock and presumably reduce stress‐shielding. However, concerns remain whether they are suitable for a wide range of patients with varying anatomy. The aim of this study was to investigate how femoral anatomy influences stress‐shielding induced by a short calcar‐guided stem across a set of 90 CT‐based femur models. A computational tool was developed that automatically selected the optimal size and position of the stem. Finite element models of the intact and implanted femurs were constructed and subjected to walking loads. Stress‐shielding was evaluated in relevant volumes of interest of the proximal femur. After a detailed anatomical analysis, linear regression was performed to find potential correlations between anatomy and stress‐shielding. Stress‐shielding was found to be highest in the proximal regions on the medial and posterior side. A highly significant negative relationship was observed between stress‐shielding and bone density; a strong positive relationship was observed with stem size and the valgus orientation of the stem with respect to the femur. The results reveal how anatomy influences stress‐shielding, and they highlight the importance of evaluating new implant designs across a large population taking into account the anatomical variability. The study demonstrates that such large population studies can be conducted in an efficient way using an automated workflow. This article is protected by copyright. All rights reserved
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... In fact, the effect of implant design [17], implant position and surgical technique [18,19] on micromotions and subsidence was already investigated [20]. In addition, FEA enables modeling of patient-specific THA [21] by testing different implants and coating on the same femoral anatomy [22] and optimizing a number of parameters before surgery. ...
... For weaker bone stress shielding was more. A significant negative relationship was present among stress shielding and bone quality which has also been confirmed in the literature of THA [38] where it was reported that stress shielding decreased when bone quality increased. The STAR design had maximum stress shielding and Mobility design the least. ...
Article
Background The long-term success of total ankle replacement (TAR) depends on both bone ingrowth and remodelling. The extreme values of implant-bone micromotion hinder bone ingrowth. Whereas, bone resorption due to bone remodelling is triggered by stress shielding. This study aims to investigate the biomechanical performance of three popular tibial designs (STAR, Salto and Mobility) for TAR with different implant-bone interfacial conditions and bone qualities. Methods In this study, CT data were used for the geometric modelling of bone. The cancellous bone was considered to be heterogeneous with location-based properties. Total 48 Finite Element (FE) models were prepared i.e., 45 implanted and 3 intact. For the three designs, three bone qualities were considered. For each bone quality, five implant-bone interface coefficients of friction were considered (0.1 to 0.5). The proximal part of the tibia was fully constrained and dorsiflexion loading condition was applied. Results There was a reduction in micromotion as the coefficient of friction increased and increase in micromotion as the bone quality reduced. The effect of implant-bone coefficient of friction was trivial on tibial stress (von Mises stress) however, bone quality and implant design was considerable. Stress shielding was seen in all the models and it increased when the bone quality degraded. Conclusions This study establishes the effect of the implant-bone interfacial condition, bone quality and implant design on implant-bone micromotion and bone stress. For long-term fixation of the tibial component, due attention should be given while selecting the tibial component design for TAR, especially for STAR and Mobility design.
... The CF was illustrated for the first time in a mid-19th century human anatomical atlas (Pirogov, 1853, as cited by;Glinkowski and Ciszek, 1989). Since then, the gross morphology and possible functional significance of the CF, especially in relation to bipedalism, have been discussed in several anatomical studies (e.g., Merkel, 1874;Bigelow, 1875;Dixon, 1910;Harty, 1957;Griffin, 1982;Stiles et al., 1990;Hammer, 2019) and increasingly considered in clinical research, particularly in relation to osteoporosis and osteoarthritis (e.g., Le Corroller et al., 2011;Thakkar et al., 2015;Tetsunaga et al., 2017;Sas et al., 2019;Zha et al., 2019). ...
Article
The calcar femorale is an internal bony structure of the proximal femur considered to be functionally related to bipedal locomotion. Among extant primates, the presence of a calcar femorale has been so far documented in extant humans and Pan and, among extinct hominins, in the Late Miocene Orrorin, in a Pliocene Australopithecus, and in a Middle Pleistocene Homo specimen. Using high-resolution microcomputed tomography, we investigated the occurrence and morphology (i.e., shape, location, and size) of the calcar femorale in an adult sample of extant humans, Pan troglodytes, Gorilla gorilla, Pongo sp., and Papio ursinus. We also investigated for the first time the occurrence and morphology of a calcar femorale in the adult proximal femoral remains of a Late Miocene great ape (Rudapithecus) and five Plio-Pleistocene hominins from Southern and Eastern Africa (Australopithecus and Paranthropus). We took four measurements: periosteal-to-tip maximum length, maximum length excluding cortical thickness, maximum vertical height, and the distance between the most anterior and posterior limits of the root. To allow for intergeneric comparisons, estimated body size was used to standardize all measurements. Nine of 10 extant humans have a well-developed calcar femorale. Among the African apes, 6 of 10 Pan and 6 of 10 Gorilla also show a distinct calcar femorale. In Pongo (n = 9), it is only present in one captive individual. None of the five investigated Papio specimens show any trace of this structure. Only calcar femorale height, which is systematically taller and extends into the lower part of the lesser trochanter, discriminates humans from extant great apes, except for one Gorilla. The calcar femorale was absent in one Paranthropus robustus and variably developed in all other investigated fossils. These results indicate that this structure cannot be considered as a diagnostic feature of habitual bipedal locomotion and emphasize the need for further investigations of its functional role.
... The mismatched stiffness of current commercially available implant materials such as PMMA and PEEK has led to complications for patients. Stress shielding, which correlates to a decrease in bone mass density and implant loosening, is one of the key concerns (Sas et al., 2019). Furthermore, increasing local stress concentrations at the implant site might result in detachment, extrusion, and infection risk. ...
Conference Paper
A surgeon’s options for correcting congenital deformities, removing oral tumours and reconstructing the head and neck region are typically restricted by the equipment available to restore bone function and appearance for the patient. New production techniques and implants with improved osseointegration performance are urgently needed to meet the growing demand for effective implants at a reasonable price. Non-degradable materials are used widely for bone repair; however, they will stay in the body indefinitely until removed surgically. Metals, such as titanium, can be used for three-dimensional (3D) printing of scaffolds. 3D printing has the potential to enhance the creation of anatomically fitting patient-specific devices with highly effective delivery in a cost-effective manner. However, metal implants have the disadvantage that they can release traces of material over time and induce immunological responses. Non-degradable polymers, such as poly (methyl methacrylate), have the disadvantages that they undergo highly exothermic polymerisation, are prone to infection and lack osseointegration. Ceramics, such as calcium phosphates, have also been studied for use in craniofacial bone regeneration, however, they have poor fracture toughness, brittleness and excessive stiffness. In view of the disadvantages associated with several of the known 3D printable materials, this thesis takes you through the development of an improved material that addresses some of the disadvantages discussed above. In this study, the synthesis of the new material referred to as “CSMA-2” is investigated along with its mechanical properties and the effects of the addition of different ratios of calcium phosphate fillers to the isosorbide-based, light-curable, degradable polymer. A comparison between two different photoinitiator systems is carried out throughout this study to ultimately find the most suited formulation for the 3D printing of the resin. Mechanical tests showed the modulus values to be between 1.7-3 kN/mm2 in CSMA-2 and its composites dependant on the photoinitiator system used. In vitro cell culture studies, using human bone osteosarcoma cells and human adipose-derived stem cells confirmed cytocompatibility of the material. Finally, Digital Light Processing 3D printing, allowed a direct photo-polymerisation of the resin to form bone- like scaffolds ready to be implanted in vivo.
... For calcar-guided stems, the software aligned the medial border of the stem along the calcar region of the medullary canal. 23 As this step was automated, it was perfectly reproducible. ...
Article
Full-text available
Aims Hip arthroplasty does not always restore normal anatomy. This is due to inaccurate surgery or lack of stem sizes. We evaluated the aptitude of four total hip arthroplasty systems to restore an anatomical and medialized hip rotation centre. Methods Using 3D templating software in 49 CT scans of non-deformed femora, we virtually implanted: 1) small uncemented calcar-guided stems with two offset options (Optimys, Mathys), 2) uncemented straight stems with two offset options (Summit, DePuy Synthes), 3) cemented undersized stems (Exeter philosophy) with three offset options (CPT, ZimmerBiomet), and 4) cemented line-to-line stems (Kerboul philosophy) with proportional offsets (Centris, Mathys). We measured the distance between the templated and the anatomical and 5 mm medialized hip rotation centre. Results Both rotation centres could be restored within 5 mm in 94% and 92% of cases, respectively. The cemented undersized stem performed best, combining freedom of stem positioning and a large offset range. The uncemented straight stem performed well because of its large and well-chosen offset range, and despite the need for cortical bone contact limiting stem positioning. The cemented line-to-line stem performed less well due to a small range of sizes and offsets. The uncemented calcar-guided stem performed worst, despite 24 sizes and a large and well-chosen offset range. This was attributed to the calcar curvature restricting the stem insertion depth along the femoral axis. Conclusion In the majority of non-deformed femora, leg length, offset, and anteversion can be restored accurately with non-modular stems during 3D templating. Failure to restore hip biomechanics is mostly due to surgical inaccuracy. Small calcar guided stems offer no advantage to restore hip biomechanics compared to more traditional designs. Cite this article: Bone Jt Open 2021;2(7):476–485.
... Stress shielding causes relative osteopenia around metal implants due to the preferential force transmission through the stiffer metallic implants. [1][2][3][4] Although the majority of total hip replacements are successful, according to a recent study, around 15% of the patients who receive a hip implant may require revision surgery within 20 years, with adverse outcomes significantly higher than primary surgeries. 5,6 Developing automated systems that are capable of quantifying and comparing the pre-and post-implant mechanical environment of the host skeleton tissue may help clinicians to use the ensued knowledge for designing patient-specific implants that tailor the mechanical response to the unique features of patient's anatomy and bone properties. ...
Article
Full-text available
Proximal femur anatomy and bone mineral density vary widely among individuals, precluding the use of one predefined finite element model to determine the stress field for all proximal femurs. This variability poses a challenge in current prosthetic hip design approach. Given the numerous options for generating computed tomography–based finite element models, selecting the best methods for defining the mechanical behavior of the proximal femur is difficult. In this study, a combination of computational and experimental approaches was used to explore the susceptibility of the predicted stress field of the proximal femur to different combinations of density-elasticity relationships, element type, element size, and calibration error. Our results suggest that finite element models with first-order voxelized elements generated by the Keyak and Falkinstein density-elasticity relationship or quadratic tetrahedral elements generated by the Morgan density-elasticity relationship lead to accurate estimations of the mechanical behavior of human femurs. Other combinations of element size, element type, and mathematical relationships produce less accurate results, especially in the cortical bone of the femoral neck and calcar region. The voxelized model was more susceptible to variation of element size and density-elasticity relationships than finite element models with quadratic tetrahedral elements. Regardless of element type, the stress fields predicted by the Keyak and Falkinstein and the Morgan relationships were the most robust to calibration error when deriving material density from computed tomography–generated Hounsfield data. These results provide insight into implementation of a robust platform for designing patient-specific implants capable of maintaining or modifying the stress in bones. This article is protected by copyright. All rights reserved.
... Although THA has achieved great success, complications such as aseptic loosening, periprosthetic joint infection, instability, leglength discrepancy and periprosthetic femoral fracture still occur sometimes. In addition, stress shielding and thigh pain may occur after surgery (4,5); stress shielding can cause bone loss around the prostheses, which can lead to periprosthetic fractures in the area of bone defects (6). ...
Article
Background: In total hip arthroplasty (THA), short-stem prostheses (SS) were designed to achieve better preservation of proximal femoral bone stock and stability than conventional stem prostheses (CS), however these effects are controversial. We aimed perform a systematic review and meta-analysis to evaluate the effectiveness of SS and CS in primary THA. Methods: Relevant randomized controlled trials (RCTs) involving the comparison of SS and CS in primary THA were screened using the electronic databases PubMed, Embase and Web of Science. Data were analyzed with the RevMan 5.3 software program and evaluated with mean difference (MD), risk ratio (RR) and 95% confidence intervals (CIs) by random or fixed-effect models. Results: Sixteen RCTs involving 1,233 patients (1,486 hips) were included. Compared with CS, the incidence of thigh pain was significantly reduced with Proxima SS (RR 0.13, 95% CI, 0.03-0.51; P=0.004). Bone mineral density (BMD) with femoral neck-preserved SS [SS (I)] showed less decrease in Gruen zone 1 (MD 14.60, 95% CI, 10.67-18.54; P<0.00001) and Gruen zone 7 (MD 9.72, 95% CI, 5.21-14.23; P<0.0001) than CS. However, the changes of BMD were not significantly different between the SS without femoral neck preservation group [SS (II)] and the CS group. In addition, no significant differences were found in the revision rate, Harris Hip Score (HHS), or maximum total point motion (MTPM) between the SS and CS groups. Conclusions: The results of this study showed that compared with CS, Proxima SS decreased the incidence of thigh pain and that SS (I) provided better proximal bone remodeling than CS. But the revision rates, HHS, and MTPM between SS and CS were similar. However, the findings of this meta-analysis require further verification in high-quality RCTs.
Article
The orthopedic device industry relies heavily on clinical evaluation to confirm the safety, performance, and clinical benefits of its implants. Limited sample size often prevents these studies from capturing the full spectrum of patient variability and real-life implant use. The device industry is accustomed to simulating benchtop tests with numerical methods and recent developments now enable virtual “in silico clinical trials” (ISCT). In this article, we describe how the advancement of computer modeling has naturally led to ISCT; outline the potential benefits of ISCT to patients, healthcare systems, manufacturers, and regulators; and identify how hurdles associated with ISCT may be overcome. In particular, we highlight a process for defining the relevant patient risks to address with ISCT, the utility of a versatile software pipeline, the necessity to ensure model credibility, and the goal of limiting regulatory uncertainty. By complementing—not replacing—traditional clinical trials with computational evidence, ISCT provides a viable technical and regulatory strategy for characterizing the full spectrum of patients, clinical conditions, and configurations that are embodied in contemporary orthopedic implant systems.
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Short-stems are becoming increasingly popular in total hip arthroplasty since they preserve the bone stock and simplify the implantation process. Short-stems are advised mainly for patients with good bone stock. The clinical use of short-stems could be enlarged to patients with poor bone stock if a cemented alternative would be available. Therefore, this study aimed to quantify the mechanical performance of a cemented short-stem and to compare the 'undersized' cementing strategy (stem one size smaller than the rasp) to the 'line-to-line' technique (stem and rasp with identical size). A prototype cemented short-stem was implanted in eight pairs of human cadaveric femora using the two cementing strategies. Four pairs were experimentally tested in a single-legged stance condition; stiffness, strength,and bone surface displacements were measured. Subject-specific nonlinear finite element models of all the implanted femora were developed, validated against the experimental data, and used to evaluate the behavior of cemented short-stems under physiological loading conditions resembling level walking. The two cementing techniques resulted in non-significant differences in stiffness and strength. Strength and stiffness as calculated from finite element were 8.7% ± 16% and 9.9% ± 15.0% higher than experimentally measured. Displacements as calculated from finite element analyses corresponded strongly (R2 ≥ 0.97) with those measured by digital image correlation. Stresses during level walking were far below the fatigue limit for bone and bone cement. The present study suggests that cemented short-stems are a promising solution in osteoporotic bone, and that the line-to-line and undersized cementing techniques provide similar outcomes.
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The current study aimed to assess the potential of different exercises triggering an osteogenic response at the femoral neck in a group of postmenopausal women. The osteogenic potential was determined by ranking the peak hip contact forces (HCFs) and consequent peak tensile and compressive strains at the superior and inferior part of the femoral neck during activities such as (fast) walking, running and resistance training exercises. Results indicate that fast walking (5-6 km/h) running and hopping induced significantly higher strains at the femoral neck than walking at 4 km/h which is considered a baseline exercise for bone preservation. Exercises with a high fracture risk such as hopping, need to be considered carefully especially in a frail elderly population and may therefore not be suitable as a training exercise. Since superior femoral neck frailness is related to elevated hip fracture risk, exercises such as fast walking (above 5 km/h) and running can be highly recommended to stimulate this particular area. Our results suggest that a training program including fast walking (above 5 km/h) and running exercises may increase or preserve the bone mineral density (BMD) at the femoral neck.
Article
Full-text available
Between 1985 and 1993, 146 patients (162 hips) had total hip replacement (THR) using a conservative uncemented femoral component. The mean age of the patients was 50.8 years and the mean follow-up was 6.2 years (2 to 13). One patient was lost to follow-up, one died within two years of surgery and one had a revision procedure after a fracture sustained in a road-traffic accident. For the remaining 159, Kaplan-Meier survival analysis was calculated for the incidence of revision because of mechanical loosening or osteolysis. Survival without mechanical loosening at both five and ten years was 98.2%. Survival without osteolysis was 99% at five and 91% at ten years. The Harris hip score improved from a mean of 66.3 before to 90.4 at follow-up. Of particular note is the lack of thigh pain in this group. Radiological analysis showed that 139 stems (88%) had no measurable subsidence, 8 (5%) had less than 2 mm and 12 (7%) had more than 2 mm. Two of the eight and one of the 12 were revised for mechanical loosening. Nine hips were revised for late loosening associated with osteolysis. No reaming of the femoral canal was associated with statistically significant less blood loss compared with a comparable control group of uncemented implants (p < 0.0001). Our study suggests that using a conservative femoral implant does not protect against wear debris but the reliable mechanical stability (98.2%) makes this an attractive design of implant particularly for young patients.
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Finite element analysis has been used extensively in the study of bone loading and implant performance, such as in the femur. The boundary conditions applied vary widely, generally producing excessive femoral deformation, and although it has been shown that the muscle forces influence femoral deflections and loading, little consideration has been given to the displacement constraints. It is hypothesised that careful application of physiologically based constraints can produce physiological deformation, and therefore straining, of the femur. Joint contact forces and a complete set of muscle forces were calculated based on the geometry of the Standardised Femur using previously validated musculoskeletal models. Five boundary condition cases were applied to a finite element model of the Standardised Femur: (A) diaphyseally constrained with hip contact and abductor forces; (B) case A plus vasti forces; (C) case A with complete set of muscle forces; (D) distally constrained with all muscle forces; (E) physiological constraints with all muscle forces. It was seen that only the physiological boundary conditions, case E, produced physiological deflections (< 2.0mm) of the femoral head in both the coronal and sagittal planes, which resulted in minimal reaction forces at the constrained nodes. Strains in the mid-diaphysis varied by up to 600 micro-strain under walking loads and 1000 micro-strain under stair climbing loads. The mode of loading, as indicated by the strain profiles on the cortex also varied substantially under these boundary conditions, which has important consequences for studies that examine localised bone loading such as fracture or bone remodelling simulations.
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Short-stemmed hip implants were introduced to conserve proximal bone mass and may facilitate the use of minimally invasive surgery, in which smaller incisions limit access to the joint. This limited access may increase the risk of surgical mal-positioning of the implant, however the sensitivity of femoral loading to such mal-positioning of a short-stemmed implant has not been studied. Finite element models were developed of a femur and a short-stemmed implant positioned to reproduce the intact hip centre, as well as with the implant placed in increased anteversion or offset. The effect of these surgical variables on femoral loading was examined for walking and stair climbing using loads from a validated musculoskeletal model. Results of the implanted models were compared with an intact model to evaluate stress shielding. Implant position had little influence on cortical strains along the length of the diaphysis, although strains decreased by up to 95% at the neck resection level compared to the intact femur. In the proximal Gruen zones I and VII strain energy density among the implanted models varied by up to 0.4 kJ/m(3) (28%) and 0.6 kJ/m(3) (24%) under walking and stair climbing, respectively. All implanted models showed characteristic proximal stress shielding, indicated by a decrease in strain energy density of up to 5.4 kJ/m(3) (69%) compared to the intact femur. Small changes in stem placement would likely have little influence on the internal loading of the femur after bone ingrowth has been achieved, however a reduction in strain energy density and therefore stress shielding was seen even for a short-stemmed implant, which may have consequences for longer-term bone remodelling.
Article
Current hip replacement femoral implants are made of fully solid materials which all have stiffness considerably higher than that of bone. This mechanical mismatch can cause significant bone resorption secondary to stress shielding, which can lead to serious complications such as periprosthetic fracture during or after revision surgery. In this work, a high strength fully porous material with tunable mechanical properties is introduced for use in hip replacement design. The implant macro geometry is based off of a short stem taper-wedge implant compatible with minimally invasive hip replacement surgery. The implant microarchitecture is fine-tuned to locally mimic bone tissue properties which results in minimum bone resorption secondary to stress shielding. We present a systematic approach for the design of a 3D printed fully porous hip implant that encompasses the whole activity spectrum of implant development, from concept generation, multiscale mechanics of porous materials, material architecture tailoring, to additive manufacturing and performance assessment via in-vitro experiments in composite femurs. We show that the fully porous implant with an optimized material microstructure can reduce the amount of bone loss secondary to stress shielding by 75% compared to a fully solid implant. This result also agrees with those of the in-vitro quasi-physiological experimental model and the corresponding finite element model for both the optimized fully porous and fully solid implant. These studies demonstrate the merit and the potential of tuning material architecture to achieve a substantial reduction of bone resorption secondary to stress shielding. This article is protected by copyright. All rights reserved
Article
This paper is motivated by the need to accurately and efficiently measure key periosteal and endosteal parameters of the femur, known to critically influence hip biomechanics following arthroplasty. The proposed approach uses statistical shape and intensity models (SSIMs) to represent the variability across a wide range of patients, in terms of femoral shape and bone density. The approach feasibility is demonstrated by using a training dataset of computer tomography scans from British subjects aged 25-106 years (75 male and 34 female). For each gender, a thousand new virtual femur geometries were generated using a subset of principal components required to capture 95% of the variance in both female and male training datasets. Significant differences were found in basic anatomic parameters between females and males: anteversion, CCD angle, femur and neck lengths, head offsets and radius, cortical thickness, densities in both Gruen and neck zones. The measured anteversion for female subjects was found to be twice as high as that for male subjects: 13 ± 6.4° vs. 6.3 ± 7.8° using the training datasets compared to 12.96 ± 6.68 vs. 5.83 ± 9.2 using the thousand virtual femurs. No significant differences were found in canal flare indexes. The proposed methodology is a valuable tool for automatically generating a large specific population of femurs, targeting specific patients, supporting implant design and femoral reconstructive surgery.
Article
This paper is concerned with the primary stability of the Furlong Evolution(®) cementless short stem across a spectrum of patient morphology. A computational tool is developed that automatically selects and positions the most suitable stem from an implant system made of a total of 48 collarless stems to best match a 3D model based on a library of CT femur scans (75males and 34 females). Finite Element contact models of reconstructed hips, subjected to physiologically-based boundary constraints and peak loads of walking mode, were simulated using a coefficient of friction of 0.4 and an interference-fit of 50μm. Maximum and average implant micromotions across the subpopulation were predicted to be 100±7μm and 7±5μm with ranges [15μm, 350μm] and [1μm, 25μm], respectively. The computed percentage of implant area with micromotions greater than reported critical values of 50μm, 100μm and 150μm never exceeded 14%, 8% and 7%, respectively. To explore the possible correlations between anatomy and implant performance, response surface models for micromotion metrics were constructed. Detailed morphological analyses were conducted and a clear nonlinear decreasing trend was observed between implant average micromotion and both the metaphyseal canal flare indices and average densities in Gruen zones. The present study demonstrates that the primary stability and tolerance of the short stem to variability in patient anatomy were high, reducing the need for patient stratification. In addition, the developed tool could be utilised to support implant design and planning of femoral reconstructive surgery. Copyright © 2015 Elsevier Ltd. All rights reserved.
Between 1985 and 1993, 146 patients (162 hips) had total hip replacement (THR) using a conservative uncemented femoral component. The mean age of the patients was 50.8 years and the mean follow-up was 6.2 years (2 to 13), One patient was lost to follow-up, one died within two years of surgery and one had a revision procedure after a fracture sustained in a road-traffic accident, For the remaining 159, Kaplan-Meier survival analysis was calculated for the incidence of revision because of mechanical loosening or osteolysis, Survival without mechanical loosening at both five and ten years was 98,2%, Survival without osteolysis was 99% at five and 91% at ten years. The Harris hip score improved from a mean of 66.3 before to 90.4 at follow-up. Of particular note is the lack of thigh pain in this group, Radiological analysis showed that 139 stems (88%) had no measurable subsidence, 8 (5%) had less than 2 mm and 12 (7%) had more than 2 mm, Two of the eight and one of the 12 were revised for mechanical loosening. Nine hips were revised for late loosening associated with osteolysis, No reaming of the femoral canal was associated with statistically significant less blood loss compared with a comparable control group of uncemented implants (p < 0.0001). Our study suggests that using a conservative femoral implant does not protect against wear debris but the reliable mechanical stability (98.2%) makes this an attractive design of implant particularly for young patients.
Article
Short stem prostheses provide conservative surgery and favorable metaphyseal load transmission. However, clinical long-term results are lacking. Therefore, in vitro trials can be used to predict bone-implant performance. In this in vitro study, primary stability and stress shielding of a new cementless short stem implant was evaluated in comparison to a straight stem using nine pairs of human cadaver femurs. Primary stability, including reversible micromotion and irreversible migration, was assessed in a hip simulator. Furthermore, changes in the pattern of cortical strain were evaluated. The short stem was more resistant to reversible micromotion and irreversible migration into retroversion. Axial stability was similar, with mean reversible micromotions of 9 µm for the short stem and 7 µm for the straight stem. Proximal load transmission was more physiological with the short stem, though both implants could not avoid stress shielding in Gruen zones 1 and 7. Primary stability of the short stem prosthesis was not negatively influenced compared to the straight shaft. Furthermore, proximal femoral strain pattern was more physiological after insertion of the short stem prosthesis. (c) 2013 Orthopaedic Research Society Published by Wiley Periodicals, Inc. J Orthop Res.
Article
One of the crucial factors for short- and long-term clinical success of total hip arthroplasty cementless implants is primary stability. Indeed, motion at the bone-implant interface above 40 μm leads to partial bone ingrowth, while motion exceeding 150 μm completely inhibits bone ingrowth. The aim of this study was to investigate the effect of two cementless femoral stem designs with different lengths on the primary stability. A finite element model of a composite Sawbones(®) fourth generation, implanted with five lengths of the straight prosthesis design and four lengths of the curved prosthesis design, was loaded with hip joint and abductor forces representing two physiological activities: fast walking and stair climbing. We found that reducing the straight stem length from 146 to 54 mm increased the average micromotion from 17 to 52 μm during fast walking, while the peak value increased from 42 to 104 μm. With the curved stem, reducing length from 105 to 54 mm increased the average micromotion from 10 to 29 μm, while the peak value increased from 37 to 101 μm. Similar findings are obtained for stair climbing for both stems. Although the present study showed that femoral stem length as well as stem design directly influences its primary stability, for the two femoral stems tested, length could be reduced substantially without compromising the primary stability. With the aim of minimising surgical invasiveness, newer femoral stem design and currently well performing stems might be used with a reduced length without compromising primary stability and hence, long-term survivorship.
Article
In the present study, a probabilistic finite element tool was assessed using an uncemented total hip replacement model. Fully bonded and frictional interfaces were investigated for combinations of three proximal femurs and two implant designs, the Proxima short stem and the IPS hip stem prostheses. The Monte Carlo method was used with two performance indicators: the percentage of bone volume that exceeded specified strain limits and the maximum nodal micromotion. The six degrees of freedom of bone-implant relative position, magnitude of the hip contact force (L), and spatial direction of L were the random variables. The distal portion of the proximal femurs was completely constrained and some of the main muscle forces acting in the hip were applied. The coefficients of the linear approximation between the random variables and the output were used as the sensitivity values. In all cases, bone-implant position related parameters were the most sensitive parameters. The results varied depending on the femur, the implant design and the interface conditions. Values of maximum nodal micromotion agreed with results from previous studies, confirming the robustness of the implemented computational tool. It was demonstrated that results from a single model study should not be generalised to the entire population of femurs and that bone variability is an important factor that should be investigated in such analyses.
Article
In the prediction of bone remodelling processes after total hip replacement (THR), modelling of the subject-specific geometry is now state-of-the-art. In this study, we demonstrate that inclusion of subject-specific loading conditions drastically influences the calculated stress distribution, and hence influences the correlation between calculated stress distributions and changes in bone mineral density (BMD) after THR. For two patients who received cementless THR, personalized finite element (FE) models of the proximal femur were generated representing the pre- and post-operative geometry. FE analyses were performed by imposing subject-specific three-dimensional hip joint contact forces as well as muscle forces calculated based on gait analysis data. Average values of the von Mises stress were calculated for relevant zones of the proximal femur. Subsequently, the load cases were interchanged and the effect on the stress distribution was evaluated. Finally, the subject-specific stress distribution was correlated to the changes in BMD at 3 and 6 months after THR. We found subject-specific differences in the stress distribution induced by specific loading conditions, as interchanging of the loading also interchanged the patterns of the stress distribution. The correlation between the calculated stress distribution and the changes in BMD were affected by the two-dimensional nature of the BMD measurement. Our results confirm the hypothesis that inclusion of subject-specific hip contact forces and muscle forces drastically influences the stress distribution in the proximal femur. In addition to patient-specific geometry, inclusion of patient-specific loading is, therefore, essential to obtain accurate input for the analysis of stress distribution after THR.
Article
In view of the increasing incidence of stem-type femoral component loosening, a detailed retrospective radiographic zonal analysis of 389 total hip replacements indicated a 19.5% incidence (76 hips) of radiological evidences of mechanical looseness, i.e., fractured acrylic cement and/or a radiolucent gap at the stem-cement or cement-bone interfaces. Detailed serial radiographic examination demonstrated progressive loosening in 56 of the 76 hips and these were categorized into mechanical modes of failure. The 4 modes of failure characterizing stem-type component progressive loosening mechanisms consisted of stem pistoning within the acrylic (3.3%), cement-embedded stem pistoning with the femur (5.1%), medial midstem pivot (2.5%), calcar pivot (0.7%) and bending (fatigue) cantilever (3.3%).
Article
Bone resorption around hip stems is a disturbing phenomenon, although its clinical significance and its eventual effects on replacement longevity are as yet uncertain. The relationship between implant flexibility and the extent of bone loss, frequently established in clinical patient series and animal experiments, does suggest that the changes in bone morphology are an effect of stress shielding and a subsequent adaptive remodeling process. This relationship was investigated using strain-adaptive bone-remodeling theory in combination with finite element models to simulate the bone remodeling process. The effects of stem material flexibility, bone flexibility, and bone reactivity on the process and its eventual outcome were studied. Stem flexibility was also related to proximal implant/bone interface stresses. The results sustain the hypothesis that the resorptive processes are an effect of bone adaptation to stress shielding. The effects of stem flexibility are confirmed by the simulation analysis. It was also established that individual differences in bone reactivity and mechanical bone quality (density and stiffness) may account for the individual variations found in patients and animal experiments. Flexible stems reduce stress shielding and bone resorption. However, they increase proximal interface stresses. Hence, the cure against bone resorption they represent may develop into increased loosening rates because of interface debonding and micromotion. The methods presented in this paper can be used to establish optimal stem-design characteristics or check the adequacy of designs in preclinical testing procedures.
Article
The subject of this article is the development and application of computer-simulation methods to predict stress-related adaptive bone remodeling, in accordance with 'Wolff's Law'. These models are based on the Finite Element Method (FEM) in combination with numerical formulations of adaptive bone-remodeling theories. In the adaptive remodeling models presented, the Strain Energy Density (SED) is used as a feed-back control variable to determine shape or bone density adaptations to alternative functional requirements, whereby homeostatic SED distribution is assumed as the remodeling objective. These models are applied to investigate the relation between 'stress shielding' and bone resorption in the femoral cortex around intramedullary prostheses, such as used in Total Hip Arthroplasty (THA). It is shown that the amount of bone resorption depends mainly on the rigidity and the bonding characteristics of the implant. Homeostatic SED can be obtained when the resorption process occurs at the periosteal surface, rather than inside the cortex, provided that the stem is adequately flexible.
Article
Many new hip prosthesis and fixation techniques have been introduced in orthopedics in recent years. Yet, none have provided superior total hip replacements (THR) in comparison to the traditional cemented Charnley concept, which nevertheless has limited long-term endurance. This review article investigates why the THR innovation process has failed. The predominant causes for long-term failure of THR are discussed. A framework of generic failure scenarios is proposed to provide guidelines for a scientifically-oriented approach to THR design, testing and clinical evaluation. It is shown that THR components are subject to incompatible design goals as regards prevention of the different failure scenarios. Neglect of those has been one important factor in the present innovation impasse. A second factor is the trial-and-error culture in orthopedic surgery, in which new devices run through the innovation cycle without proper testing or rigorous postoperative analysis. The third factor is ineffective regulation of marketing approval with respect to orthopedic implants. Scientific research in orthopedics and related sciences has produced new methods for systematic design evaluation, pre-clinical testing and clinical trials. These can provide a basis for self-regulation and self-control by the orthopedic community, in all stages of the innovation process.
Article
The resultant hip joint force, its orientation and the moments were measured in two patients during walking and running using telemetering total hip prostheses. One patient underwent bilateral joint replacement and a second patient, additionally suffering from a neuropathic disease and atactic gait patterns, received one instrumented hip implant. The joint loading was observed over the first 30 and 18 months, respectively, following implantation. In the first patient the median peak forces increased with the walking speed from about 280% of the patient's body weight (BW) at 1 km h-1 to approximately 480% BW at 5 km h-1. Jogging and very fast walking both raised the forces to about 550% BW; stumbling on one occasion caused magnitudes of 720% BW. In the second patient median forces at 3 km h-1 were about 410% BW and a force of 870% BW was observed during stumbling. During all types of activities, the direction of the peak force in the frontal plane changed only slightly when the force magnitude was high. Perpendicular to the long femoral axis, the peak force acted predominantly from medial to lateral. The component from ventral to dorsal increased at higher force magnitudes. In one hip in the first patient and in the second patient the direction of large forces approximated the average anteversion of the natural femur. The torsional moments around the stem of the implant were 40.3 N m in the first patient and 24 N m in the second.
Article
Subject-specific finite element (FE) computer models of the proximal femur in hip replacement could potentially predict stress-shielding and subsequent bone loss in individual patients. Before such predictions can be made, it is important first to determine if between subject differences in stress-shielding are sensitive to poorly defined parameters such as the load and the bone material properties. In this study we investigate if subject-specific FE models provide consistent stress-shielding patterns in the bone, independent of the choice of the loading conditions and the bone density–modulus relationship used in the computer model. FE models of two right canine femurs with and without implants were constructed based on contiguous computed tomography (CT) scans so that subject-specific estimates of stress-shielding could be calculated. Four different loading conditions and two bone density–modulus relationships were tested. Stress-shielding was defined as the decrease of strain energy per gram bone mass in the femur with the implant in place relative to the intact femur.
Article
The rehabilitation program adopted immediately after a cementless total hip replacement is a very important factor, because of the known relationship between osseointegration and implant micromotion. The present study was aimed to evaluate which type of task is the most critical in terms of bone-implant relative micromotion. Both inter-task and inter-subject variability were taken into account to verify if the movement strategy could be determinant on this assessment. A previously validated finite element model was used to predict the peak total micromovements over the entire bone-implant contact surface in four different patients, performing nine different tasks, using published data on joint forces recorded by instrumented hip prostheses. The results predicted by the various simulations suggest that while stair climbing is surely a critical task for primary stability, for some subjects other tasks may be as critical as stair climbing. From a variance analysis for simple crossover design on the predicted peak micromotion, the inter-subject variability had much more influence on the primary stability of cementless implant than the inter-task variability. Even if the results of Patient IBL, who was reported to have difficulties to perform any activities in a normal way, were excluded from the statistical analysis, the inter-subject variability remained still higher than the inter-task variability. The results obtained from simulations suggest that the strategy the hip replacement patient adopts to perform a given motor task, may be, for the implant stability, equally or even more critical than the type of motor task performed.
Article
One outstanding issue regarding the relationship between elastic modulus and density for trabecular bone is whether the relationship depends on anatomic site. To address this, on-axis elastic moduli and apparent densities were measured for 142 specimens of human trabecular bone from the vertebra (n=61), proximal tibia (n=31), femoral greater trochanter (n=23), and femoral neck (n=27). Specimens were obtained from 61 cadavers (mean+/-SD age=67+/-15 years). Experimental protocols were used that minimized end-artifact errors and controlled for specimen orientation. Tissue moduli were computed for a subset of 18 specimens using high-resolution linear finite element analyses and also using two previously developed theoretical relationships (Bone 25 (1999) 481; J. Elasticity 53 (1999) 125). Resultant power law regressions between modulus and density did depend on anatomic site, as determined via an analysis of covariance. The inter-site differences were among the leading coefficients (p<0.02), but not the exponents (p>0.08), which ranged 1.49-2.18. At a given density, specimens from the tibia had higher moduli than those from the vertebra (p=0.01) and femoral neck (p=0.002); those from the trochanter had higher moduli than the vertebra (p=0.02). These differences could be as large as almost 50%, and errors in predicted values of modulus increased by up to 65% when site-dependence was ignored. These results indicate that there is no universal modulus-density relationship for on-axis loading. Tissue moduli computed using methods that account for inter-site architectural variations did not differ across site (p>0.15), suggesting that the site-specificity in apparent modulus-density relationships may be attributed to differences in architecture.
Article
The stability of joint endoprostheses depends on the loading conditions to which the implant-bone complex is exposed. Due to a lack of appropriate muscle force data, less complex loading conditions tend to be considered in vitro. The goal of this study was to develop a load profile that better simulates the in vivo loading conditions of a "typical" total hip replacement patient and considers the interdependence of muscle and joint forces. The development of the load profile was based on a computer model of the lower extremities that has been validated against in vivo data. This model was simplified by grouping functionally similar hip muscles. Muscle and joint contact forces were computed for an average data set of up to four patients throughout walking and stair climbing. The calculated hip contact forces were compared to the average of the in vivo measured forces. The final derived load profile included the forces of up to four muscles at the instances of maximum in vivo hip joint loading during both walking and stair climbing. The hip contact forces differed by less than 10% from the peak in vivo value for a "typical" patient. The derived load profile presented here is the first that is based on validated musculoskeletal analyses and seems achievable in an in vitro test set-up. It should therefore form the basis for further standardisation of pre-clinical testing by providing a more realistic approximation of physiological loading conditions.
Article
Periprosthetic stress-shielding after total hip arthroplasty (THA) is a well-known phenomenon. Many authors have used the finite element (FE) method to show the effects of THA on animal or human femora. In most cases they have performed cadaver experiments. The current project is a FE analysis based on a retrospective computerized tomography (CT) in vivo data set of 11 patients 12 years after THA. In order to control the analysis, a computationally created stem was implanted at the femur model of the not operated contralateral side. In comparison to the not operated side, there was a significant reduction of the strain energy density (SED) values in all regions of interest (ROI) with the greatest effect near the distal tip of the stem. Only zone 1 showed no clear trend which may be due to load application at the greater trochanter causing local strain peaks. The median SED values changed by -31.65% (ROI 1), -25.64% (ROI 2), -30.82% (ROI 3), -12.35% (ROI 4), -40.10% (ROI 5), -30.37% (ROI 6) and -43.38% (ROI 7). As far as we are aware, the current combination of in vivo CT density data with FE strain analyses after THA is based on the largest number of patients and the longest follow-up period. This combination enables analysis and prediction of the influence of implantation upon bone and can be compared with of remodelling theories. The assessment of mechanical strain data during a follow-up trial could be a new approach for analyzing different hip stems in clinical biomechanics.
Article
The prediction of the stress-state and fracture risk induced in bones by various loading conditions in individual patients using subject-specific finite element models still represents a challenge in orthopaedic biomechanics. The accuracy of the strain predictions reported in the literature is variable and generally not satisfactory. The aim of the present study was to evaluate if a proper choice of the density-elasticity relationship can lead to accurate strain predictions in the frame of an automatic subject-specific model generation strategy. To this aim, a combined numerical-experimental study was performed comparing finite element predicted strains with strain-gauges measurements obtained on eight cadaver proximal femurs, each instrumented with 15 rosettes mostly concentrated in the bone metaphyses, tested non-destructively in vitro under six different loading scenarios. Three different density-elasticity power relationships were selected from the literature and implemented in the finite element models derived from computed tomography data. The results of the present study confirm the great influence of the density-elasticity relationship used on the accuracy of numerical predictions. One of the tested constitutive laws provided a very good agreement (R(2)=0.91, RMSE lower than 10% of the maximum measured value) between numerical calculations and experimental measurements. The presented results show, in addition, that the adoption of a single density-elasticity relationship over the whole bone density range is adequate to obtain an accuracy that is already suitable for many applications.
The Swedish hip arthroplasty register: annual report 2014
  • G Garellick
  • J Kärrholm
  • H Lindahl
Defining the anatomic range of short-stem implantationcalcarguided restoration of individual ccd-angle
  • M P Kovacevic
  • K P Kutzner
  • P Rehbein
Kovacevic MP, Kutzner KP, Rehbein P, et al. 2014. Defining the anatomic range of short-stem implantationcalcarguided restoration of individual ccd-angle. Hip Int 24:493-553.
  • G Garellick
  • J Lindahl
Garellick G, K€ arrholm J, Lindahl H, et al. 2014. The Swedish hip arthroplasty register: annual report 2014. G€ oteborg, Sweden: 254. https://doi.org/10.18158/B1OyzZ00Z
Defining the anatomic range of short‐stem implantation‐calcarguided restoration of individual ccd‐angle
  • Kovacevic MP