Aims. The aim of the study was to investigate whether the primary stability of press-fit acetabular components can be improved by altering the impaction procedure. Methods. Three impaction procedures were used to implant acetabular components into human cadaveric acetabula using a powered impaction device. An impaction frequency of 1 Hz until complete component seating served as reference. Overimpaction was simulated by adding ten strokes after complete component seating. High-frequency implantation was performed at 6 Hz. The lever-out moment of the acetabular components was used as measure for primary stability. Permanent bone deformation was assessed by comparison of double micro-CT (µCT) measurements before and after impaction. Acetabular component deformation and impaction forces were recorded, and the extent of bone-implant contact was determined from 3D laser scans. Results. Overimpaction reduced primary acetabular component stability (p = 0.038) but did not significantly increase strain release after implantation (p = 0.117) or plastic deformations (p = 0.193). Higher press-fits were associated with larger polar gaps for the 1 Hz reference impaction (p = 0.002, R. 2. = 0.77), with a similar trend for overimpaction (p = 0.082, R. 2. = 0.31). High-frequency impaction did not significantly increase primary stability (p = 0.170) at lower impaction forces (p = 0.001); it was associated with smaller plastic deformations (p = 0.035, R. 2. = 0.34) and a trend for increased acetabular component relaxation between strokes (p = 0.112). Higher press-fit was not related to larger polar gaps for the 6 Hz impaction (p = 0.346). Conclusion. Overimpaction of press-fit acetabular components should be prevented since additional strokes can be associated with increased bone damage and reduced primary stability as shown in this study. High-frequency impaction at 6 Hz was shown to be beneficial compared with 1 Hz impaction. This benefit has to be confirmed in clinical studies. Cite this article: Bone Joint J 2023;105-B(3):261–268

Objective. This study compared the primary stability of two commercially available acetabular components from the same manufacturer, which differ only in geometry; a hemispherical and a peripherally enhanced design (peripheral self-locking (PSL)). The objective was to determine whether altered geometry resulted in better primary stability. Methods. Acetabular components were seated with 0.8 mm to 2 mm interference fits in reamed polyethylene bone substrate of two different densities (0.22 g/cm. 3. and 0.45 g/cm. 3. ). The primary stability of each component design was investigated by measuring the peak failure load during uniaxial pull-out and tangential lever-out tests. Results. There was no statistically significant difference in seating force (p = 0.104) or primary stability (pull-out p = 0.171, lever-out p = 0.087) of the two components in the low-density substrate. Similarly, in the high-density substrate, there was no statistically significant difference in the peak pull-out force (p = 0.154) or lever-out moment (p = 0.574) between the designs. However, the PSL component required a significantly higher seating force than the hemispherical cup in the high-density bone analogue (p = 0.006). Conclusions. Higher seating forces associated with the PSL design may result in inadequate seating and increased risk of component malpositioning or acetabular fracture in the intra-operative setting in high-density bone stock. Our results, if translated clinically, suggest that a purely hemispherical geometry may have an advantage over a peripherally enhanced geometry in high density bone stock. Cite this article: Bone Joint Res 2013;2:264–9

Introduction. Achieving an appropriate primary stability after implantation is a prerequisite for the long-term viability of a dental implant. Virtual testing of the bone-implant construct can be performed with finite element (FE) simulation to predict primary stability prior to implantation. In order to be translated to clinical practice, such FE modeling must be based on clinically available imaging methods. The aim of this study was to validate an FE model of dental implant primary stability using cone beam computed tomography (CBCT) with ex vivo mechanical testing. Method. Three cadaveric mandibles (male donors, 87-97 years old) were scanned by CBCT. Twenty-three bone samples were extracted from the bones and conventional dental implants (Ø4.0mm, 9.5mm length) were inserted in each. The implanted specimens were tested under quasi-static bending-compression load (cf. ISO 14801). Sample-specific homogenized FE (hFE) models were created from the CBCT images and meshed with hexahedral elements. A non-linear constitutive model with element-wise density-based material properties was used to simulate bone and the implant was considered rigid. The experimental loading conditions were replicated in the FE model and the ultimate force was evaluated. Result. The experimental ultimate force ranged between 67 N and 789 N. The simulated ultimate force correlated better with the experimental ultimate force (R. 2. =0.71) than the peri-implant bone density (R. 2. =0.30). Conclusion. The developed hFE model was demonstrated to provide stronger prediction of primary stability than peri-implant bone density. Therefore, hFE Simulations based on this clinically available low-radiation imaging modality, is a promising technology that could be used in future as a surgery planning tool to assist the clinician in evaluating the load-bearing capacity of an implantation site. Acknowledgements. Funding: EU's Horizon 2020 grant No: 953128 (I-SMarD). Dental implants: THOMMEN Medical AG

Aims. Surgeons and most engineers believe that bone compaction improves implant primary stability without causing undue damage to the bone itself. In this study, we developed a murine distal femoral implant model and tested this dogma. Methods. Each mouse received two femoral implants, one placed into a site prepared by drilling and the other into the contralateral site prepared by drilling followed by stepwise condensation. Results. Condensation significantly increased peri-implant bone density but it also produced higher strains at the interface between the bone and implant, which led to significantly more bone microdamage. Despite increased peri-implant bone density, condensation did not improve implant primary stability as measured by an in vivo lateral stability test. Ultimately, the condensed bone underwent resorption, which delayed the onset of new bone formation around the implant. Conclusion. Collectively, these multiscale analyses demonstrate that condensation does not positively contribute to implant stability or to new peri-implant bone formation. Cite this article:Bone Joint Res. 2020;9(2):60–70

Introduction. Primary stability is an important factor for long-term implant survival in total hip arthroplasty. In revision surgery, implant fixation becomes especially challenging due the acetabular bone defects, which are often present. Previous studies on primary stability of revision components often applied simplified geometrical defect shapes in a variety of sizes and locations. The objectives of this study were to (1) develop a realistic defect model in terms of defect volume and shape based on a clinically existing acetabular bone defect, (2) develop a surrogate acetabular test model, and (3) exemplarily apply the developed approach by testing the primary stability of a pressfit-cup with and without bone graft substitute (BGS). Materials & Methods. Based on clinical computed tomography data and a method previously published [1], volume and shape information of a representative defect, chosen in consultation with four senior hip revision surgeons, was derived. Volume and shape of the representative defect was approximated by nine reaming procedures with hemispherical acetabular reamers, resulting in a simplified defect with comparable volume (18.9 ml original vs. 18.8 ml simplified) and shape. From this simplified defect (Defect D), three additional defect models (Defect A, B, C) were derived by excluding certain reaming procedures, resulting in four defect models to step-wise test different acetabular revision components. A surrogate acetabular model made of 20 PCF polyurethane foam with the main support structures was developed [2]. For the exemplary test, three series for Defect A were defined: Native (acetabulum without defect), Empty (defect acetabulum without filling), Filled (defect acetabulum with BGS filling). All series were treated with a pressfit-cup and subjected to dynamic axial load in direction of maximum resultant force during level walking. Minimum load was 300 N and maximum load was increased step-wise from 600 N to 3000 N. Total relative motion between cup and foam, consisting of inducible displacement and migration, was assessed with the optical measurement system gom Aramis (gom GmbH, Braunschweig, DE). Results. Total relative motion increased with increasing load, with a maximum of 0.63 mm for Native, 0.86 mm for Filled, and 1.9 mm for Empty. At load stage 1800 N, total relative motion in Empty was 11.0-fold increased in comparison to Native, but could be reduced to a 3.3-fold increase in Filled. Discussion. The objective of this study was to develop a simplified, yet realistic and modular defect model which could be used to step-wise test different treatment strategies. Applicability of the developed test setup was shown by assessing primary stability of a pressfit-cup in a native, empty, and filled situation. The presented method could potentially be used as a modular test setup to compare different acetabular revision components in a standardized way. For any figures or tables, please contact authors directly

Introduction. Cementless total knee arthroplasty (TKA) implants use an interference fit to achieve fixation, which depends on the difference between the inner dimensions of the implant and outer dimensions of the bone. However, the most optimal interference fit is still unclear. A higher interference fit could lead to a superior fixation, but it could also cause bone abrasion and permanent deformation during implantation. Therefore, this study aims to investigate the effect of increasing the interference fit from 350 µm to 700 µm on the primary stability of cementless tibial implants by measuring micromotions and gaps at the bone-implant interface when subjected to two loading conditions. Methods. Two cementless e.motion® tibial components (Total Knee System, B. Braun) with different interference fit and surface coating were implanted in six pairs of relatively young human cadaver tibias (47–60 years). The Orthoload peak loads of gait (1960N) and squat (1935N) were applied to the specimens with a custom made load applicator (Figure 1A). The micromotions (shear displacement) and opening/closing gaps (normal displacement) were measured with Digital Image Correlation (DIC) in 6 different regions of interest (ROIs - Figure 1B). Two General Linear Mixed Models (GLMMs) were created with micromotions and interfacial gaps as dependent variables, bone quality, loading conditions, ROIs, and interference fit implants as independent variables, and the cadaver specimens as subject variables. Results. No significant difference was found for the micromotions between the two interference fit implants (gait p=0.755, squat p=0.232), nor for interfacial gaps (gait p=0.474, squat p=0.269). In contrast, significant differences were found for the ROIs in the two dependent variables (p < 0.001). The micromotions in the anterior ROIs (AM and AL) showed fewer micromotions for the low interference fit implant (Figure 2). More closing gaps (negative values) were seen for all ROIs (Figure 3), except in AM ROI during squat, which showed opening gaps (positive values). The posterior ROIs (PM and PL) showed more closing than seen in the anterior ROIs (AM and AL) for both loading configurations. Discussion. The results presented here demonstrate that increasing the interference fit from 350 µm to 700 µm does not affect the micromotions at the implant-bone interface of tibial TKA. While micromotions values were all below the threshold for bone ingrowth (40 µm), closing gaps were quite substantial (∼−150 µm). Since cementless e.motion® TKA components with an interference fit of 350 µm had shown a survival rate of 96.2% after 8.3 years postoperatively, interfacial gaps can be expected to be within a threshold value that can guarantee good primary stability. Moreover, increasing the interference fit to 700 µm can be considered a good range for an interference fit. For any figures or tables, please contact the authors directly

Introduction. Primary stability is achieved by the press fit technique, where an oversized component is inserted into an undersized reamed cavity. The major geometric design of an acetabular shell is hemispherical type. On the other one, there are the hemielliptical type acetabular shells for enhanced peripheral contact. In the case of developmental dysplasia of the hip (DDH), the aseptic loosening may be induced by instability due to decreased in the contact area between the acetabular shell and host bone. The aim of this study was to assess the effect of reaming size on the primary stability of two different outer geometry shells in DDH models. Materials and methods. The authors evaluated hemispherical (Continuum Acetabular Shell, Zimmer Biomet G.K.) and hemielliptical (Trabecular Metal Modular Acetabular Shell, Zimmer Biomet G.K.) acetabular shells. Both shells had a 50 mm outer diameter and same tantalum 3D highly porous surface. An acetabular bone model was prepared using a solid rigid polyurethane foam block with 20 pcf density (Sawbones, Pacific Research Laboratories Inc.) as a synthetic bone substrate. Press fit conditions were every 1 mm from 4 mm under reaming to 2 mm over reaming. To simulate the acetabular dysplasia the synthetic bone substrate was cut diagonally at 40°. Where, the acetabular inclination and cup-CE angle were assumed to 40° and 10°, respectively. Acetabular components were installed with 5 kN by a uniaxial universal testing machine (Autograph AGS-X, Shimadzu Corporation). Primary stability was evaluated by lever-out test. The lever-out test was performed in 4 mm undersized to 2 mm oversized reaming conditions. Lever out moment was calculated from the multiplication of the maximum load and the moment arm for primary stability of the shell. The sample size was 6 for each shell type. Results. The hemisphererical acetabular shell had the maximum lever out moment in 3 mm under reaming condition (7.4 ± 0.4 N·m). The hemielliptical acetabular shell had the maximum lever out moment in 1 mm under reaming condition (8.7 ± 0.8 N·m). Furthermore, the lever out moment of the hemielliptical acetabular shell was significantly 1.2 times greater by the t-test than the hemispherical acetabular shell under the maximum primary fixation conditions. Discussion. The risk parameter of the acetabular loosening is indicated the lack of lateral bony support. The hemielliptical shell was not adversely effected more than the hemispherical shell. Furthermore, the reaming condition of the most primary fixation on the hemielliptical shell was 1 mm under reaming, and was a more general operating procedure than the hemispherical shell (3 mm under reaming). From this study, it was suggested that the hemielliptical shell might be expected excellent clinical outcomes in severe acetabular dysplasia hips. For any figures or tables, please contact authors directly

Introduction. Short stems have been developed for some years for preservation of femoral bone stock and achieve physiological proximal loading. Shortening stem length is a merit for bone stock preservation. However, it might lead to reduction of primary stability. We investigated relationship between stem length and primary stability by patient specific finite element analysis (FEA). Materials and Methods. Thirty-one hips in 31 patients were performed total hip arthroplasty with standard length tapered wedge-shaped (TW) cementless stem (CTi-II: Corin, Cirencester, UK). There were 6 males and 25 females. The average age at operation was 69 years old. The average body mass index was 23.9 kg/m2. Primary diagnoses were secondary osteoarthritis due to developmental dysplasia of the hip in 29 hips. Femoral canal shapes were normal in 21, stovepipe in 6 and champagne-flute in 4 hips. Bone qualities were type A in 6, B in 19 and C in 6 hips. The patients underwent computed tomography (CT) preoperatively and postoperatively. We constructed preoperative three dimensional (3D) femur surface models from preoperative CT data with individual bone mineral density (BMD) mapping. The postoperative 3D femur and rough stem surface models were obtained from postoperative CT data. The coordinates of the postoperative femur were transformed to fit the preoperative femur model. A precise stem model constructed using computer-assisted design data was matched to the transformed rough stem model using the iterative closest point algorithm. We obtained a patient-specific model with the proximal bone geometry, allocation of BMD and stem alignment. We estimated the average of axial and rotational micromotion (MM) at stem-bone interface and the ratio of area (MM â�¦ 40 micrometers) on the porous surface in order to analyze primary stability of TW stem with several lengths (standard (100 %), 75 %, 50 %, 40 % and 30 % length). Results. The average MM in standard length stem was 14.3 micrometers and the ratio of area with MM â�¦ 40 micrometers was 97.9 %. The average of axial and rotational MM in shorter length (75 %) stem were respectively 9.7, 8.3 micrometers. There were no differences in the average of axial and rotational MM between standard and shorter (75 %) length stems. MM at the porous surface was increased as the stem length grew shorter. The ratio of area with MM â�¦ 40 micrometers on the porous surface were reduced by 50 to 80 % in −40 % or less length stem, comparing with the standard length stem. Discussion and Conclusion. The present FEA on the stem length and MM demonstrated that primary stability in 40 % or less short length TW stem was extensively reduced, which might lead to failure of bone ingrowth on the porous surface and early loosening. Shortening of stem length less than 50 % is a risk for reduced primary stability in TW stem

Introduction. Primary stability is essential for long-term performance of cementless femoral components. There is debate as to whether collars contribute to primary stability. The results from experimental studies and finite element (FE) analysis have been variable and contradictory. Subtle differences in performance are often swamped by variation between cadaveric specimens in vitro, whereas FE studies tend to be performed on a single femur. However, FE studies have the potential to make comparisons of implant designs within the same cohort of femurs, allowing for subtle performance differences to be identified if present. This study investigates the effect of a collar on primary stability of a femoral prosthesis across a representative cohort of femurs. Materials and Methods. FE models were generated from QCT scans of eight cadaveric femurs taken from the Melbourne Femur Collection (4 male and 4 female; BMI: 18.7 – 36.8 kg.m-2; age: 59 – 80 years) which were of joint replacement age. Heterogeneous bone material properties were assigned based on the CT greyscale information. Each femur was implanted with the collared and collarless version of Corail femoral stem (DePuy, Leeds, United Kingdom). The stems were sized and positioned so that the prosthesis filled the medullary canal with minimal gap between the prosthesis and the inner boundary of the cortical bone. The peak muscle and joint contact forces associated with level gait were applied and the distal femur was rigidly fixed. The forces were scaled based on the body weight for each subject. Micromotion, as well as microstrains at the bone-prosthesis interface were measured for each subject. Paired t-test was run to compare the micromotion and the microstrains measured for the collared and collarless prosthesis. Results. There were no significant differences in micromotion (p > 0.005) and microstrains (p » 0.005) between collared and collarless prostheses. The mean of the median micromotions for the collared and the collarless prostheses were 19.4 microns and 20.5 microns, respectively. The mean of the median equivalent strains at the bone-implant interface for the collared and the collarless prostheses were 828.5 microstrains and 824.3 microstrains, respectively. The mean percentage of the area at the contact interface that experienced equivalent strains lower than 2000 microstrains was 69.9% for the collared and 70.0% for the collarless designs. The mean percentage of the contact area at the bone-prosthesis interface that experience equivalent strains greater than 7000 microstrains, the yield strain, was only 9.9% for the collared and 5.7% for the collarless designs. Discussion and conclusions. There was considerable variation across the cohort of femurs, with a factor of two difference for both micromotion and interface strain While small differences were noted between the collared and collarless prostheses implanted in the same femur, these differences were minimal and were likely to have little affects on primary stability, at least for a level gait load case. More demanding load cases may result in greater differences between collared and collarless implants. The results suggest that the addition of a collar in routine cases may not enhance the primary stability of a cementless hip stem

Introduction. Revision hip arthroplasty is a technically challenging operation as proximal bony deficits preclude the use of standard implants. Longer distally fixing stems are therefore required to achieve primary stability. Aims. This work aims to compare the primary stability and biomechanical properties of a new design of tapered fluted modular femoral stem (Redapt®, Smith & Nephew) to that of a conical fluted stem (Restoration®, Stryker). It is hypothesized that the taper will provide improved rotational stability under cyclical loading. Materials & Methods. 7 Pairs of cadaveric femora were obtained according to strict inclusion/exclusion criteria. Each underwent dual energy x-ray absorptiometry and calibration plain-film radiographs were taken. Digital templating was performed using TraumaCad (Voyant Health, Brainlab) to determine implant sizing. Both stems are fluted, modular and manufactured from titanium (figure 1). The control stem (Restoration) featured a straight conical design and the investigation stem (Redapt) a straight tapered design. Implantation was performed by a revision arthroplasty surgeon familiar with both systems. Proximal bone deficiency was reproduced using an extended trochanteric osteotomy with removal of metaphyseal bone before reattaching the osteotomy. Primary stability in the axial, sagittal and coronal planes was assessed using micromotion transducers (HBM, Darmstadt, Germany) (figure 2a) and also by Radiostereometric Analysis (RSA). RSA employs simultaneous biplanar radiographs to measure relative movement. Two 1 mm tantalum beads were mounted on the prosthesis with the centre of the femoral head taken as the third reference point. Beads were placed proximally in the surrounding bone as rigid body markers. Each bone was potted according to the ISO standard for fatigue testing and cyclically loaded at 1 Hz for at least 3 increments (750–350N, 1000–350N, 1500–350N) for 1000 cycles. RSA radiographs were taken at baseline and on completion of each cycle. A strain analysis was concurrently performed using a PhotoStress ® (Vishay Precision Group, Raleigh, USA) photoelastic coating on the medial femoral cortex. Each bone was loaded intact and then with the prosthesis in-situ at 500N increments until strain fringes were identified. Once testing was completed, the stems were sectioned at the femoral isthmus and data is presented on the cross-sectional fit and fill observed. Results. Both stem designs showed comparable primary stability with all stems achieving clinically acceptable micromotion (<150 μm) when loaded at body weight. A larger proportion of the control stems remained stable as loading increased to x2–3 body weight. Transducer-recorded migration appeared greatest in the axial plane (y axis) (figure 2b) with negligible distal movement in the coronal or sagittal planes. Point motion analysis (RSA) indicated most movement to be in the coronal plane (x-axis) (figure 2c) whereas segment motion analysis showed rotation about the long axis of the prosthesis to be largest. Photoelastic strain patterns were transferred more distally in both designs, however substantial stress shielding was also observed (figure 3). Discussion/Conclusion. Both designs achieved adequate distal fixation and primary stability under representative clinical loading conditions. This work supports the continued use of this novel stem design for revision surgery in the presence of extensive proximal bone loss

There is a large variability associated with hip stem designs, patient anatomy, bone mechanical property, surgical procedure, loading, etc. Designers and orthopaedists aim at improving the performance of hip stems and reducing their sensitivity to this variability. This study focuses on the primary stability of a cementless short stem across the spectrum of patient morphology using a total of 109 femoral reconstructions, based on segmentation of patient CT scan data. A statistical approach is proposed for assessing the variability in bone shape and density [Blanc, 2012]. For each gender, a thousand new femur geometries were generated using a subset of principal components required to capture 95% of the variance in both female and male training datasets [Bah, 2013]. A computational tool (Figure 1) is then developed that automatically selects and positions the most suitable implant (distal diameter 6–17 mm, low and high offset, 126° and 133° CCD angle) to best match each CT-based 3D femur model (75 males and 34 females), following detailed measurements of key anatomical parameters. Finite Element contact models of reconstructed hips, subjected to physiologically-based boundary constraints and peak loads of walking mode [Speirs, 2007] were simulated using a coefficient of fricition of 0.4 and an interference-fit of 50μm [Abdul-Kadir, 2008]. Results showed that the maximum and average implant micromotions across the subpopulation were 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 using the so-called Kriging regression methodology, based on Gaussian processes. A clear nonlinear decreasing trend was revealed between implant average micromotion and the metaphyseal canal flare indexes (MCFI) measured in the medial-lateral (ML), anterio-posterior (AP) and femoral neck-oriented directions but also the average bone density in each Gruen zone. In contrast, no clear influence of the remaining clinically important parameters (neck length and offsets, femoral anteversion and CCD angle, standard canal flares, patient BMI and weight or stem size) to implant average micromotion was found. In conclusion, the present study demonstrates that the primary stability and tolerance of the short stem to variability in patient anatomy were high, suggesting no need for patient stratification. The developed methodology, based on detailed morphological analysis, accurate implant selection and positioning, prediction of implant micromotion and primary stability, is a novel and valuable tool to support implant design and planning of femoral reconstructive surgery

Introduction:. Extensive bone defects of the proximal femur e.g. due to aseptic loosening might require the implantation of megaprostheses. In the literature high loosening rates of such megaprostheses have been reported. However, different fixation methods have been developed to achieve adequate implant stability, which is reflected by differing design characteristics of the commonly used implants. Yet, a biomechanical comparison of these designs has not been reported. The aim of our study was to analyse potential differences in the biomechanical behaviour of three megaprostheses with different designs by measuring the primary rotational stability in vitro. Methods:. Four different stem designs [Group A: Megasystem-C® (Link), Group B: MUTARS®(Implantcast), Group C: GMRS™ (Stryker) and Group D: Segmental System (Zimmer); see Fig. 1] were implanted into 16 Sawbones® after generating a segmental AAOS Typ 2 defect. Using an established method to analyse the rotational stability, a cyclic axial torque of ± 7.0 Nm along the longitudinal stem axis was applied. Micromotions were measured at defined levels of the bone and the implant [Fig. 2]. The calculation of relative micromotions at the bone-implant interface allowed classifying the rotational implant stability. Results:. All four different implants exhibited low micromotions, indicating adequate primary stability. Lowest micromotions for all designs were located near the femoral isthmus [Fig. 3]. The extent of primary stability and the global implant fixation pattern differed considerably and could be related to the different design concepts. Discussion:. Compared to other implant designs, all stems resulted in low relative motions regardless their design. The conical Megasystem-C® stem seems to lock in the proximal isthmus of the femur, whereas the MUTARS® stem seems to have a total fixation. Its hexagonal cross-section might have a good interlocking effect against rotational force application. Similarly, the GMRS™ stem shows a total fixation with little tendency to the distal part. The very rough porous-coated surface seems to generate a comparable fixation method to the hexagonal MUTARS® stem. However, the four longitudinal expansions in the proximal part of the GMRS™ stem might not have such a high rotational stability effect as expected. Compared to the other stems, the Segmental System stem showed very low relative micromotions in the proximal part. This sharp fluted stem seems to engrave itself into the bone. Within this study all stems seemed to achieve an adequate primary rotational stability. We could show that stem design could qualitatively and quantitatively influence the initial fixation behavior of megaprostheses regarding biomechanical tests, like primary stability measurements in synthetic femurs. These experiences should be considered regarding the choice of stem fixation design in specific defect situations

Summary Statement. Proximal femoral bony deficits present a surgical and biomechanical challenge to implant longevity in revision hip arthroplasty. This work finds comparable primary stability when a distally fixing tapered fluted stem was compared with a conical design in cadaveric tests. Introduction. Proximal bony deficits complicate revision hip surgery and compromise implant survival. Longer distally fixing stems which bypass such defects are therefore required to achieve stability compatible with bony ingrowth and implant longevity. Aims. It is hypothesised that a tapered stem will provide superior rotational stability to a conical design. This work therefore aims to compare the primary stability and biomechanical properties of a new design of tapered fluted modular femoral stem (Redapt®, Smith & Nephew) with that of a conical fluted stem (Restoration®, Stryker). Materials & Methods. 7 Pairs of cadaveric femora were obtained according to strict inclusion/exclusion criteria. Each underwent dual energy x-ray absorptiometry and calibration plain-film radiographs were taken. Digital templating was performed using TraumaCad (Voyant Health, Brainlab) to determine implant sizing. Both stems are fluted, modular and manufactured from titanium. The control stem (Restoration) featured a straight conical design and the investigation stem (Redapt) a straight tapered design. Implantation was performed by a revision arthroplasty surgeon familiar with both systems. Proximal bone deficiency was reproduced using an extended trochanteric osteotomy with removal of metaphyseal bone before reattaching the osteotomy. Primary stability in the axial, sagittal and coronal planes was assessed using micromotion transducers (HBM, Darmstadt, Germany) and also by Radiostereometric Analysis (RSA). RSA employs simultaneous biplanar radiographs to measure relative movement. Two 1mm tantalum beads were mounted on the prosthesis with the centre of the femoral head taken as the third reference point. Beads were placed proximally in the surrounding bone as rigid body markers. Each bone was potted according to the ISO standard for fatigue testing and cyclically loaded at 1Hz for at least 3 increments (750–350N, 1000–350N, 1500–350N) for 1000 cycles. RSA radiographs were taken at baseline and on completion of each cycle. A strain analysis was concurrently performed using a PhotoStress® (Vishay Precision Group, Raleigh, USA) photoelastic coating on the medial femoral cortex. Each bone was loaded intact and then with the prosthesis in-situ at 500N increments until strain fringes were identified. Once testing was completed, the stems were sectioned at the femoral isthmus and data is presented on the cross-sectional fit and fill observed. Results. Both stem designs showed comparable primary stability with all stems achieving clinically acceptable micromotion (<150 μm) when loaded at body weight. A larger proportion of the control stems remained stable as loading increased to x2-3 body weight. Transducer-recorded migration appeared greatest in the axial plane (y axis) with negligible distal movement in the coronal or sagittal planes. Point motion analysis (RSA) indicated most movement to be in the coronal plane (x-axis) whereas segment motion analysis showed rotation about the long axis of the prosthesis to be largest. Photoelastic strain patterns were transferred more distally in both designs, however substantial stress shielding was also observed. Discussion/Conclusion. Both designs achieved adequate distal fixation and primary stability under representative clinical loading conditions. This work supports the continued use of this novel stem design for revision surgery in the presence of extensive proximal bone loss

Introduction: Adequate congruency and primary stability are vital for good long-term results after mosaicplasty. The strength of press-fit stability of the grafts depends upon the length and diameter of the graft, extent of dilation and bone quality. The aim of our study was to quantify the effect of graft diameter and dilation length on the primary stability of single osteochondral grafts against compression and compare the stability of single and multiple osteochondral grafts in an in vitro biomechanical animal model. Methods: In the single graft series one osteochondral graft was transplanted from the trochlea of porcine femurs to the weight-bearing area of the lateral femoral condyle, while in the multiple graft series three grafts were transplanted in a row or in circular fashion in the same position. We used the MosaicPlasty instruments (Acufex, Smith & Nephew Inc. MA, USA). The specimen was installed on a testing machine (Computer controlled ZWICK FR005TH type tensile machine, Zwick GmbH Ulm, Germany) and the graft was first pushed in level with the surrounding cartilage surface, then it was pushed 3 mm deeper. The push-in forces were measured and the compression curve was registered. Results: In the case of single 4.5-mm grafts, the mean level push-in force was 43.5 N, pushing 3 mm deeper needed a mean of 92.5 N (n=13). In the case of single 6.5-mm grafts, level push-in needed a mean of 76.2 N, while for pushing 3 mm deeper a mean of 122.2 N force had to be used (n=14). The length of the drill-hole and the dilation were both 20 mm in each setting. When using 20 mm long drill-holes and 15 mm dilation length, the values above were found to be 36.6 N and 122.5 N in the case of 4.5-mm grafts (n=12). In case of multiple grafting level push-in needed a mean force of 31.8 N in the row series, while pushing 3 mm deeper needed a mean of 52.17 N (n=7). In the circle series level push-in needed a mean of 30.44 N, while for pushing 3 mm deeper a mean of 54.33 N force had to be used (n=9). Conclusions: These results suggest that grafts of greater diameter are more stable in absolute values and the stability may be increased by shorter dilation length, while level push-in forces do not increase significantly. Multiple grafts may not be as stable as single grafts after transplantation and transplantation in a row or in circular fashion does not influence stability

Introduction. Successful designs of total hip replacement need to be robust to surgery-related variability. Until recently, only simple parametric studies have explored the influence of surgical variability [1]. This study presents a systematic method for quantifying the effect of variability in positioning on the primary stability of femoral stems using finite element (FE) models. Methods. Patient specific finite element models were generated of two femurs, one male and one female. An automated algorithm positioned and sized a Corail stem (DePuy Synthes, Warsaw) into each of the femurs to achieve maximum fill of the medullary canal without breaching into the cortical bone boundaries.. Peak joint contact and muscle forces associated with level gait were applied[2] and scaled to the body mass of each subject, whilst the distal femur was rigidly constrained. The space prone to surgical variation was defined by the “gap” between the stem and the inner boundary of the cortical bone. The anterior/posterior and the varus/valgus alignment of the stem within this “gap” was controlled by varying the location of the points defining the shaft axis. The points were taken at 20% and 80% of the stem length (Figure 1). The anteversion angle as well as the vertical and the medial position of the stem were controlled by changing the location of the head centre within the femoral head radius. The location of these points was varied using Latin Hypercube sampling to generate 200 models per femur, each with a unique stem position. The risk of failure was evaluated based on stem micromotion, equivalent strains, and percentage of the bone-prosthesis contact area experiencing more than 7000 µstrains [3]. Results. The range of positions covered in this study adhered to the anatomy of the subjects (Table 1) and none of the stem positions breached into the cortical bone of the femur. The 90th percentile peri-prosthetic strains were between 1770 – 4792 µstrains for the male subject, and 2710 – 11260µstrains for the female subject. The 90th percentile micromotion was between (15.6 – 47) µm for the male subject, and (42.4 – 102.4) µm for the female subject. The percentage of the contact area experiencing more than 7000 µstrains was between (0% – 0.33%) for the male subject, and (0% – 12%) for the female subject. Discussion. A systematic method for studying the effect of surgical-related variation on primary stability was presented its applicability demonstrated on two femurs. The study found that variation in stem position may result in large variation (up to 1.5 times the baseline position) in strains and micromotions. The magnitude Up to three times the magnitudes for the ideal stem position. This method can be applied to larger samples to understand the influence of different alignment parameters on the primary stability of femoral stems

Introduction. Cementless tibial fixation has been used for over 30 years. There are several potential advantages including preservation of bone stock and ease of revision. More importantly, for young active patients there is the potential for increased longevity of fixation. However, the clinical results have been variable, with reports of extensive radiolucent lines, rapid early migration and aseptic loosening. Problems appear to stem from a failure to become sufficiently osseointegrated, which in turn suggests a lack of primary stability. In order to achieve boney ingrowth, interface micromotions should be less than 50 microns, whereas fibrous tissue formation is known to occur if micrmotions are in excess of 150 microns. The degree of micromotion at the bone-implant interface are dependent on the kinematics and kinetics of the replaced joint. Finite element analyses has been used to assess primary stability, however, it is becoming increasing difficult to differentiate performance. The aim of this study was too examine the micromotion for a variety of different activities for three commercially available tibial tray designs. Methods. A finite element model of the implanted proximal tibia was generated form CT scans of a 72 year old male and material properties were assigned based on the Hounsfield units. Three tray designs were evaluated: LCS, Duofix and Sigma (DePuy Inc, Warsaw USA). The implants were assumed to be debonded, with a coefficient of friction of 0.4 applied to the bone-implant interface except for the porous coated region of the Duofix design, which was assumed to be 0.6. The distal portion the tibia was rigidly constrained. Five activities were simulated based on data from Orthoload.com (patient K1L) including walking, stair ascent, stair descent, sitting down and a deep knee bend. The three force and three moment time histories were discritised to give between 44 and 48 individual load steps. Custom written scripts were used to generate composite peak micromotion plots, which report the peak micromotion that occurs at each point of the contact surface during the gait cycle. The primary stability was then assessed by reporting the maximum micromotion, the average peak micromotion and the percentage of the contact area experiencing micromoitons less than 50 microns. Results and discussion. Similar trends were observed for all three designs across the range of activities. Stair ascent and descent generated the highest micromotions, closely followed by level gait. Across these three activities the mean peak (maximum) micromotions ranged from 64-78 (186-239) microns for PFC Sigma, 61-72 (199-251) microns for Duofix and 92-106 (229-264) microns for LCS. The peak micromotions did not necessarily occur at the peak loads. For instance, for level walking the peak micromotions occurred when there were low axial forces, but moderate varus-valgus moments. This highlights the need to examine the whole gait cycle in order to properly determine the initial stability tibiae tray designs. By exploring a range of activities and interrogating the entire contact surface, it is easier to differentiate between the relative performance of different implant designs

Background. Use of a baseplate with a smaller diameter in reverse shoulder arthroplasty has been recommended, especially in patients with a small glenoid or insufficient bony stock due to severe glenoid wear. However, effect of a smaller baseplate on stability of the glenoid component has not been evaluated. The purpose of this study was to determine whether a smaller baseplate (25 mm) is beneficial to the initial primary stability of the glenoid component compared to that with a baseplate of a commonly used size (29 mm) by finite element analysis. Methods. Computed tomography (CT) scans of fourteen scapulae were acquired from cadavers with no apparent deformity or degenerative change. Glenoid diameter corresponding to the diameter of the inferior circle of glenoid was measured using a caliper and classified into the small and large glenoid groups based on 25mm diameter. CT slices were used to construct 3-dimensional models with Mimics (Materialise, Leuven, Belgium). A corresponding 3D Tornier Aequalis® Reversed Shoulder prosthesis model was generated by laser scanning (Rexcan 3D Laser Scanner, Solutionix, Seoul, Korea). Glenoid components with 25mm and 28mm diameter of the baseplate were implanted into the scapular of small and large glenoid group, respectively. Finite element models were constructed using Hypermesh 11.0 (Altair Engineering, Troy, MI, USA) and a reverse engineering program (Rapidform 3D Systems, Inc., Rock Hill, SC, USA). Abaqus 6.10 (Dassault Systemes, Waltham, MA) was used to simulate 30. o. , 60. o. , and 90. o. glenohumeral abduction in the scapular plane. Single axial loads of 686N (1 BW) at angles of 30. o. , 60. o. , and 90. o. abduction were applied to the center of the glenosphere parallel to the long axis of the humeral stem. Relative micromotion at the middle and inferior thirds bone–glenoid component interface, and distribution of bone stress under the glenoid component and around the screws were analyzed. Wilcoxon's rank-sum test was used for statistical comparison and p < 0.05 was considered as a minimum level of statistical significance. Results. In small glenoid group, micromotion at the middle and inferior thirds of the glenoid-glenosphere interface at angles of 30. o. and 60. o. abduction were significantly greater in the 29mm baseplate than in the 25mm baseplate. There was no significant difference in micromotion at angle of 90. o. abduction between 25mm and 29mm baseplate. In large glenoid group, there was no statistically significant difference in micromotion between 25mm and 29mm baseplate at all angles of abduction. In small glenoid group, maximum bone stress was measured at the point of cortical engagement of the inferior screw and was statistically greater in the 29mm baseplate than in the 25mm baseplate. In large glenoid group, there was no statistically significant difference of maximum bone stress around the inferior screw between 25mm and 29mm baseplates. Conclusions. Use of a baseplate with a smaller diameter (25 mm) in reverse shoulder arthroplasty is suitable for improving the primary stability of the glenoid component, especially in small glenoid

Purpose: The Exeter technique opens new perspectives for the treatment of femoral bone loss observed at revision hip arthroplasty. Early migration of the implant, considered by the advocates of the technique to be beneficial when limited, can, in the absence of secondary instability, weaken the cement shield leading to early revision. Several publications on this topic have examined the improvement in primary stability achieved by modifying the impaction technique or by searching for the ideal size of the grafts. The purpose of the present study was to examine the reproducibility of this method and its effect on transformation of the allograft. Material and methods: We performed a prospective analysis of outcome in 46 patients operated on since 1996. The Poste-Merle-d’Aubigné (PMA) clinical score and the Ling and Gie radiographic score as well as the SOFCOT score for substance loss were determined. We used frozen fragmented allografts without consideration of graft size. A standard sized femoral implant was used in all cases. Results: Mean follow-up was 3 years (range 12 – 66 months). Four patients were not followed beyond 9 months because of major complications requiring revision surgery (infection, fracture of the femur, malposition) or patient death (stroke). For the remaining 42 patients, loss of femoral stock was scored I in 6, II in 23, III in 13. The functional score improved from 9.13±3.9 preoperatively to 16.07±2.5 postoperatively. Radiographically, bone lines were observed in the graft in 36 patients, associated with bone remodelling in ten. In six patients, the allograft exhibited a heterogeneous aspect. Three implants migrated 4 mm. Defective distal sealing was noted in all three. One prosthesis implanted in a varus position worsened before stabilising. Discussion: This technique is a reliable method since primary stability of the implant was obtained in 90% of the cases and was maintained during long follow-up. This did not prevent graft remodelling

Introduction. Pre-clinical testing of orthopaedic devices could be improved by comparing performance with established implants with known clinical histories. Corail and Summit (DePuy Synthes, Warsaw) are femoral stems with proven survivorship of 95.1% and 98.1% at 10 years [1], which makes them good candidates as benchmarks when evaluating new stem designs. Hence, the aim of this study was to establish benchmark data relating to the primary stability of Corail and Summit stems. Methods. Finite Element (FE) simulations were run for 34 femurs (from the Melbourne femur collection) for a diverse patient cohort of joint replacement age (50 – 80 yrs). To account for the diversity in shape, the cohort included femurs with the maxima, minima and medians for 26 geometric parameters. Subject-specific FE models were generated from CT scans. An in-house developed algorithm positioned idealized versions of Corail and Summit (Figure 1) into each of the femur models so that the stem and femur shaft axes were aligned, and the vertical offset between the trunnion centre and the femoral head centre was minimised. For such a position, the algorithm selected the size that achieved maximum fill of the medullary canal without breaching the cortical bone boundaries. Joint contact and muscle forces were calculated for level gait and stair climbing[2] and scaled to the body mass of each subject. Femurs were rigidly constrained at the condyles. Risk of failure was assessed based on (i) stem micromotion, (ii) equivalent strains (iii) percentage of the bone-prosthesis contact area experiencing micromotions < 50 μm, micromotions > 150 μm and strains > 7000 μstrains [3]. Results. Stair climb loads resulted in higher micromotion and interface strains, compared to level gait loads. For level gait, on average, Corail had 89% and Summit had 91% of the contact area experiencing less than 50 μm and less than 1% of the contact area with micromotion greater than 150 μm. For stair climbing, the average area experiencing <50 μm was about 75% for both stems. On average, Corail and Summit had less than 1% of the contact area with micromotion greater than 150 μm during stair climbing. The average percentage of the contact are with strains greater than 7000 μstrains was about 2% for both stems during level gait, and 8% (Corail), 10% (Summit) during stair climbing (Figure 2). Discussion and Conclusion. It is desirable for the micromotion at the entire contact area to be below 50 μm. Despite the reported good survivorship of Corail and Summit [1], results of the FE simulations do not show such a distribution. Instead, results suggest that primary stability may be achieved with up to 25% of the contact area with micromotion greater than 50 μm. Hence, the 75th percentile may be a suitable metric for benchmarking femoral stems

Background. Short bone-conserving femoral stem implants were developed to achieve more physiological, proximal bone loading than conventional femoral stems. Concerns have arisen, however, that improved loading may be offset by lower primary stability because of the reduced potential area for bony contact. Aims. The aim of this study was to determine the primary stability of a novel short femoral stem compared with a conventional femoral stem following cementless total hip arthroplasty (THA), in a prospective, blinded, randomised, controlled trial using radiostereometric analysis. Methods. Fifty-three patients were randomised to receive cementless THA with either a short femoral stem or a conventional femoral stem. The CONSORT diagram is shown (Figure I). Surgery was performed at one institution by three surgeons. 26 patients received the short stem and 23 received the conventional stem. Complete follow-up was available on 40 patients (82%). All patients received the same cementless acetabular component. The primary outcomes were dynamically inducible micromotion and migration of the femoral stems at two years. Both were measured using radiostereometric analysis. Radiographs for radiostereometric analysis were taken post-operatively and at three, six, 12, 18 and 24 months. Validated geometric algorithms were used to determine the relative three-dimensional position of the prosthetic stem and host bone. Results. At two years, there was significantly less subsidence (inferior migration) of the short femoral stem (head: 0.28mm; 95% confidence interval [CI] +/−0.17; SD 0.38; tip: 0.10mm; 95% CI +/− 0.18; SD 0.41) compared with the conventional stem (head: 0.61mm, 95% CI +/−0.26, SD 0.55, P=0.03; tip: 0.44mm, 95% CI +/−0.21, SD 0.43, P=0.02) (Figure II). There was no significant difference in dynamically inducible micromotion. Conclusion. This study demonstrates that the short femoral stem has a stable and predictable migration. However, longer-term survival analysis remains important. For any figures and tables, please contact the authors directly