Migration behaviour of 2 clinically excellent cementless stems with different design rationales: 5-year follow-up of a randomised RSA-study.

INTRODUCTION: Excellent long-term survival has been reported for both the Taperloc and the Mallory-Head cementless stems. However, little is known about the migration behaviour of these stems which have different design rationales. The purpose of this randomised clinical trial was to compare the migration and clinical outcomes of these stems during 5 years of follow-up. METHODS: 42 consecutive hips in 38 patients scheduled to receive cementless THA were randomised to either a Taperloc or a Mallory-Head stem. Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 26, and 52 weeks, and annually thereafter. Primary outcome was stem migration measured using roentgen stereophotogrammetric analysis (RSA) and secondary outcomes were the Harris Hip Score (HHS) and 36-Item Short-Form Health Survey (SF-36). No patients were lost to follow-up; in 1 patient the THA was removed due to deep infection 3 months postoperatively. In 6 hips migration measurements were not possible due to insufficient marker configuration. RESULTS: Throughout the follow-up period of 5 years, 3-dimensional migration was comparable between the Taperloc and the Mallory-Head stems (p-values > 0.05). However, at the 5-year follow-up point the retroversion of the Mallory-Head stem was 0.9° more than the Taperloc stem (p = 0.04). Initial subsidence and retroversion were respectively as large as 6.8 mm and 3.6° for the Taperloc stem and 5 mm and 3.6° for the Mallory-Head stem. After the first postoperative year, both implants had stabilised. The mean increment of HHS, as well as the SF-36 scores during the 5-year follow-up, were comparable between the 2 stems. CONCLUSIONS: The excellent long-term survival of both designs was confirmed in this study showing comparable initial migration with subsequent stabilisation. However, the Taperloc design with a flat, wedged geometry showed better rotational stability.

Long-term migration of a cementless stem with different bioactive coatings. Data from a "prime" RSA study: lessons learned.

Background and purpose - Little is known about the long-term migration pattern of cementless stems in total hip arthroplasty (THA). Furthermore, the role of bioactive coatings in fixation, and thus migration, remains uncertain. Hydroxyapatite (HA) is the most commonly used bioactive coating. However, delamination of the coating might induce loosening. Alternatively, fluorapatite (FA) has proved to be more thermostable than HA, thereby potentially increasing longevity. We assessed the long-term migration of cementless stems with different coatings using radiostereometric analysis (RSA), thereby establishing a reference for acceptable migration. Patients and methods - 61 THAs in 53 patients were randomized to receive either a HA, FA, or uncoated Mallory-Head Porous stem during the years 1992 to 1994. Primary outcome was stem migration measured using RSA and secondary outcome was the Harris Hip Score (HHS). Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 25 and 52 weeks, and annually thereafter. At the 25-year follow-up, 12 patients (17 THAs) had died and 1 patient (1 THA) was lost to follow-up. Due to the high number of missing second-day postoperative RSA radiographs, the 1-year postoperative RSA radiograph was used as baseline for the comparative analyses. Results - Mean follow-up was 17 years (SD 6.6). All stems showed initial rapid migration with median subsidence of 0.2 mm (-0.1 to 0.6) and median retroversion of 0.9° (-3.2 to 2) at 12 months, followed by stable migration reaching a plateau phase. No stem was revised, albeit 1 stem showed continuous subsidence up to 1.5 mm. Comparing the different coatings, we could not find a statistically significant difference in overall 25-year migration (p-values > 0.05). Median subsidence at 15-year follow-up was for HA -0.1 mm (-0.4 to 0.2), for FA 0 mm (-0.1 to 0.2), and for uncoated stems 0.2 mm (-0.1 to 0.5). Median internal rotation at 15-year follow-up was for HA not available, for FA 1.1° (-0.5 to 2.6), and for uncoated stems 0° (-0.5 to 0.4). HHS were also comparable (p-values > 0.05), with at 15-year follow-up for HA 85 points (41-99), for FA 76 points (61-90), and for uncoated stems 79 points (74-90). Interpretation - The long-term migration pattern of cementless stems using different bioactive coatings has not previously been described. No beneficial effect, or side effect at long-term follow-up of bioactive coatings, was found. The provided migration data can be used in future research to establish thresholds for acceptable migration patterns cementless stem designs.

Equivalent 2-year stabilization of uncemented tibial component migration despite higher early migration compared with cemented fixation: an RSA study on 360 total knee arthroplasties.

Background and purpose - Thresholds of implant migration for predicting long-term successful fixation of tibial components in total knee arthroplasty have not separated cemented and uncemented fixation. We compared implant migration of cemented and uncemented components at 1 year and as the change in migration from 1 to 2 years. Patients and methods - Implant migration of 360 tibial components measured using radiostereometric analysis was compared at 1 year and as the change in migration from 1 to 2 years in 222 cemented components (3 implant designs) and 138 uncemented components (5 implant designs). Results - 1-year maximum total point motion was lower for the cemented tibial components compared with the uncemented components (median = 0.31 mm [0.03-2.98] versus 0.63 mm [0.11-5.19] respectively, p < 0.001, mixed model). The change in migration from 1 to 2 years, however, was equivalent for cemented and uncemented components (mean [SD] 0.06 mm [0.19] and 0.07 mm [0.27] mm respectively, p = 0.6, mixed model). Interpretation - These findings suggest that current thresholds of acceptable migration at 1 year may be better optimized by considering cemented and uncemented tibial components separately as higher early migration of uncemented components was not associated with decreased stability from 1 to 2 years.

Migration and clinical outcome of mobile-bearing versus fixed-bearing single-radius total knee arthroplasty.

Background and purpose - Mobile-bearing total knee prostheses (TKPs) were developed in the 1970s in an attempt to increase function and improve implant longevity. However, modern fixed-bearing designs like the single-radius TKP may provide similar advantages. We compared tibial component migration measured with radiostereometric analysis (RSA) and clinical outcome of otherwise similarly designed cemented fixed-bearing and mobile-bearing single-radius TKPs. Patients and methods - RSA measurements and clinical scores were assessed in 46 randomized patients at baseline, 6 months, 1 year, and annually thereafter up to 6 years postoperatively. A linear mixed-effects model was used to analyze the repeated measurements. Results - Both groups showed comparable migration (p = 0.3), with a mean migration at 6-year follow-up of 0.90 mm (95% CI 0.49-1.41) for the fixed-bearing group compared with 1.22 mm (95% CI 0.75-1.80) for the mobile-bearing group. Clinical outcomes were similar between groups. 1 fixed-bearing knee was revised for aseptic loosening after 6 years and 2 knees (1 in each group) were revised for late infection. 2 knees (1 in each group) were suspected for loosening due to excessive migration. Another mobile-bearing knee was revised after an insert dislocation due to failure of the locking mechanism 6 weeks postoperatively, after which study inclusion was preliminary terminated. Interpretation - Fixed-bearing and mobile-bearing single-radius TKPs showed similar migration. The latter may, however, expose patients to more complex surgical techniques and risks such as insert dislocations inherent to this rotating-platform design.

Peri-prosthetic tissue cells show osteogenic capacity to differentiate into the osteoblastic lineage.

During the process of aseptic loosening of prostheses, particulate wear debris induces a continuous inflammatory-like response resulting in the formation of a layer of fibrous peri-prosthetic tissue at the bone-prosthesis interface. The current treatment for loosening is revision surgery which is associated with a high-morbidity rate, especially in old patients. Therefore, less invasive alternatives are necessary. One approach could be to re-establish osseointegration of the prosthesis by inducing osteoblast differentiation in the peri-prosthetic tissue. Therefore, the aim of this study was to investigate the capacity of peri-prosthetic tissue cells to differentiate into the osteoblast lineage. Cells isolated from peri-prosthetic tissue samples (n = 22)-obtained during revision surgeries-were cultured under normal and several osteogenic culture conditions. Osteogenic differentiation was assessed by measurement of Alkaline Phosphatse (ALP), mineralization of the matrix and expression of several osteogenic genes. Cells cultured in osteogenic medium showed a significant increase in ALP staining (p = 0.024), mineralization of the matrix (p < 0.001) and ALP gene expression (p = 0.014) compared to normal culture medium. Addition of bone morphogenetic proteins (BMPs), a specific GSK3ß inhibitor (GIN) or a combination of BMP and GIN to osteogenic medium could not increase ALP staining, mineralization, and ALP gene expression. In one donor, addition of GIN was required to induce mineralization of the matrix. Overall, we observed a high-inter-donor variability in response to osteogenic stimuli. In conclusion, peri-prosthetic tissue cells, cultured under osteogenic conditions, can produce alkaline phosphatase and mineralized matrix, and therefore show characteristics of differentiation into the osteoblastic lineage. © 2016 The Authors. Journal of Orthopaedic Research published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society. J Orthop Res 35:1732-1742, 2017.

Structural and mechanical characterisation of the peri-prosthetic tissue surrounding loosened hip prostheses. An explorative study.

Very little is known about the structure and properties of peri-prosthetic fibrous tissue that is found around loose orthopaedic implants. We describe a method for characterizing the structural organisation (histology, confocal microscopy) as well as the nano- and micro-scale mechanical behaviour (atomic force microscopy, nanoindentation) of peri-prosthetic fibrous tissue. The tissue was collected from 11 patients undergoing revision surgery due to aseptic loosening. Sirius Red and Movat histological staining procedures indicated that the tissue mainly consists of collagen fibres and ground substance. However, large inter- and intra-patient variations in the relative proportions of these tissue components were found, as well as in collagen fibre orientation and possibly also maturation. The nano-scale Young׳s moduli ranged from 0-950kPa, but showed large inter-patient variability. When the results per sample were presented in a probability density function, we could roughly discriminate one peak in the 0-100kPa range and/or one peak in the 100-500Pa range. These nano-scale moduli seem to respectively present the mechanical properties of glycosaminoglycan (GAG) and collagen molecules. The majority of the micro-scale Young׳s moduli ranged between 0.5 and 2.0kPa for all samples. This explorative study provides new insights in (the variations of) structural organisation and mechanical properties of peri-prosthetic tissue.

Palacos compared to Palamed bone cement in total hip replacement: a randomized controlled trial.

Background and purpose - Stability and survival of cemented total hip prostheses is dependent on a multitude of factors, including the type of cement that is used. Bone cements vary in viscosity, from low to medium and high. There have been few clinical RSA studies comparing the performance of low- and high-viscosity bone cements. We compared the migration behavior of the Stanmore hip stem cemented using novel low-viscosity Palamed bone cement with that of the same stem cemented with conventional high-viscosity Palacos bone cement. Patients and methods - We performed a randomized controlled study involving 39 patients (40 hips) undergoing primary total hip replacement for primary or secondary osteoarthritis. 22 patients (22 hips) were randomized to Palacos and 17 patients (18 hips) were randomized to Palamed. Migration was determined by RSA. Results - None of these 40 hips had been revised at the 10-year follow-up mark. To our knowledge, the patients who died before they reached the 10-year endpoint still had the implant in situ. No statistically significant or clinically significant differences were found between the 2 groups for mean translations, rotations, and maximum total-point motion (MTPM). Interpretation - We found similar migration of the Stanmore stem in the high-viscosity Palacos cement group and the low-viscosity Palamed cement group. We therefore expect that the risk of aseptic loosening with the new Palamed cement would be comparable to that with the conventional Palacos cement. The choice of which type of bone cement to use is therefore up to the surgeon's preference.

A fluoroscopy-based planning and guidance software tool for minimally invasive hip refixation by cement injection.

PURPOSE: In orthopaedics, minimally invasive injection of bone cement is an established technique. We present HipRFX, a software tool for planning and guiding a cement injection procedure for stabilizing a loosening hip prosthesis. HipRFX works by analysing a pre-operative CT and intraoperative C-arm fluoroscopic images. METHODS: HipRFX simulates the intraoperative fluoroscopic views that a surgeon would see on a display panel. Structures are rendered by modelling their X-ray attenuation. These are then compared to actual fluoroscopic images which allow cement volumes to be estimated. Five human cadaver legs were used to validate the software in conjunction with real percutaneous cement injection into artificially created periprothetic lesions. RESULTS: Based on intraoperatively obtained fluoroscopic images, our software was able to estimate the cement volume that reached the pre-operatively planned targets. The actual median target lesion volume was 3.58 ml (range 3.17-4.64 ml). The median error in computed cement filling, as a percentage of target volume, was 5.3% (range 2.2-14.8%). Cement filling was between 17.6 and 55.4% (median 51.8%). CONCLUSIONS: As a proof of concept, HipRFX was capable of simulating intraoperative fluoroscopic C-arm images. Furthermore, it provided estimates of the fraction of injected cement deposited at its intended target location, as opposed to cement that leaked away. This level of knowledge is usually unavailable to the surgeon viewing a fluoroscopic image and may aid in evaluating the success of a percutaneous cement injection intervention.

Innate immune response and implant loosening: Interferon gamma is inversely associated with early migration of total knee prostheses.

To allow prediction of the risk of loosening prior to surgery, we investigated the relationship between innate immune cytokine response via TLR2 stimulation and early migration of six different knee prostheses using RSA (radiostereometry). This study included 114 patients of a prospective RSA-cohort who received a total knee arthroplasty. Whole blood cytokine responses were obtained by ex vivo stimulation with tripalmitoyl-S-glycerylcysteine (Pam3Cys-SK4) for assessment of the TLR2 immune response. Early migration was calculated using the maximum total point motion (MTPM) 1 year post surgery. Principal component analysis (PCA) was applied to the cytokine data to reduce the correlated data of individual cytokines and identified two components. Subsequently, linear mixed model analyses were applied with adjustments for gender, age, BMI, time-to-blood sampling, and prosthesis type. Component 1, consisting of IFNγ, IL-12p40, IL-10, IL-1ß, TNFα, and IL-6, showed a significant inverse association (ß = -0.128; p = 0.041) with MTPM. Further analysis showed that IFNγ (ß = -0.161, p = 0.008) had the highest contribution to this association and is particularly found in patients receiving another prosthesis than Nexgen (ß = -0.239; p < 0.001). In conclusion, patients with high levels of IFNγ upon stimulation of TLR2 are at lower risk of early migration of their knee prosthesis.

Inhibition of GSK3ß Stimulates BMP Signaling and Decreases SOST Expression Which Results in Enhanced Osteoblast Differentiation.

Both bone morphogenetic protein (BMP) and Wnt signaling have significant roles in osteoblast differentiation and the interaction between BMP and Wnt signaling is well known. Sclerostin is an important inhibitor of bone formation, inhibiting Wnt signaling and downstream effects of BMP such as alkaline phosphatase activity and matrix mineralization in vitro. However, little is known about the effect of BMP and Wnt signaling interaction on the regulation of SOST, the gene encoding sclerostin. Possibly, uncoupling of osteoblast differentiation regulators and SOST expression could increase osteoblast differentiation. Therefore, we investigated the effect of BMP and Wnt signaling interaction on the expression of SOST and the subsequent effect on osteoblast differentiation. Human osteosarcoma cells (SaOS-2) and murine pre-osteoblast cells (KS483) were treated with different concentrations of Wnt3a, a specific GSK3ß inhibitor (GIN) and BMP4. Both Wnt3a and GIN increased BMP4-induced BMP signaling and BMP4 increased Wnt3a and GIN-induced Wnt signaling. However, the effect of GIN was much stronger. Quantitative RT-PCR analysis showed that SOST expression dose-dependently decreased with increasing Wnt signaling, while BMP4 induced SOST expression. GIN significantly decreased the BMP4-induced SOST expression. This resulted in an increased osteoblast differentiation as measured by ALP activity in the medium and matrix mineralization. We conclude that GSK3ß inhibition by GIN caused an uncoupling of BMP signaling and SOST expression, resulting in an increased BMP4-induced osteoblast differentiation. This effect can possibly be used in clinical practice to induce local bone formation, for example, fracture healing or osseointegration of implants.

Early subsidence of shape-closed hip arthroplasty stems is associated with late revision. A systematic review and meta-analysis of 24 RSA studies and 56 survival studies.

BACKGROUND AND PURPOSE: Few studies have addressed the association between early migration of femoral stems and late aseptic revision in total hip arthroplasty. We performed a meta-regression analysis on 2 parallel systematic reviews and meta-analyses to determine the association between early migration and late aseptic revision of femoral stems. PATIENTS AND METHODS: Of the 2 reviews, one covered early migration data obtained from radiostereometric analysis (RSA) studies and the other covered long-term aseptic revision rates obtained from survival studies with endpoint revision for aseptic loosening. Stems were stratified according to the design concept: cemented shape-closed, cemented force-closed, and uncemented. A weighted regression model was used to assess the association between early migration and late aseptic revision, and to correct for confounders. Thresholds for acceptable and unacceptable migration were determined in accordance with the national joint registries (≤ 5% revision at 10 years) and the NICE criteria (≤ 10% revision at 10 years). RESULTS: 24 studies (731 stems) were included in the RSA review and 56 studies (20,599 stems) were included in the survival analysis review. Combining both reviews for the 3 design concepts showed that for every 0.1-mm increase in 2-year subsidence, as measured with RSA, there was a 4% increase in revision rate for the shape-closed stem designs. This association remained after correction for age, sex, diagnosis, hospital type, continent, and study quality. The threshold for acceptable migration of shape-closed designs was defined at 0.15 mm; stems subsiding less than 0.15 mm in 2 years had revision rates of less than 5% at 10 years, while stems exceeding 0.15 mm subsidence had revision rates of more than 5%. INTERPRETATION: There was a clinically relevant association between early subsidence of shape-closed femoral stems and late revision for aseptic loosening. This association can be used to assess the safety of shape-closed stem designs. The published research is not sufficient to allow us to make any conclusions regarding such an association for the force-closed and uncemented stems.

Numerical optimization of alignment reproducibility for customizable surgical guides.

PURPOSE: Computer-assisted orthopedic surgery aims at minimizing invasiveness, postoperative pain, and morbidity with computer-assisted preoperative planning and intra-operative guidance techniques, of which camera-based navigation and patient-specific templates (PST) are the most common. PSTs are one-time templates that guide the surgeon initially in cutting slits or drilling holes. This method can be extended to reusable and customizable surgical guides (CSG), which can be adapted to the patients' bone. Determining the right set of CSG input parameters by hand is a challenging task, given the vast amount of input parameter combinations and the complex physical interaction between the PST/CSG and the bone. METHODS: This paper introduces a novel algorithm to solve the problem of choosing the right set of input parameters. Our approach predicts how well a CSG instance is able to reproduce the planned alignment based on a physical simulation and uses a genetic optimization algorithm to determine optimal configurations. We validate our technique with a prototype of a pin-based CSG and nine rapid prototyped distal femora. RESULTS: The proposed optimization technique has been compared to manual optimization by experts, as well as participants with domain experience. Using the optimization technique, the alignment errors remained within practical boundaries of 1.2 mm translation and [Formula: see text] rotation error. In all cases, the proposed method outperformed manual optimization. CONCLUSIONS: Manually optimizing CSG parameters turns out to be a counterintuitive task. Even after training, subjects with and without anatomical background fail in choosing appropriate CSG configurations. Our optimization algorithm ensures that the CSG is configured correctly, and we could demonstrate that the intended alignment of the CSG is accurately reproduced on all tested bone geometries.

Waterjet cutting of periprosthetic interface tissue in loosened hip prostheses: an in vitro feasibility study.

Waterjet cutting technology is considered a promising technology to be used for minimally invasive removal of interface tissue surrounding aseptically loose hip prostheses. The goal of this study was to investigate the feasibility of waterjet cutting of interface tissue membrane. Waterjets with 0.2 mm and 0.6 mm diameter, a stand-off distance of 5 mm, and a traverse speed of 0.5 mm/s were used to cut interface tissue samples in half. The water flow through the nozzle was controlled by means of a valve. By changing the flow, the resulting waterjet pressure was regulated. Tissue sample thickness and the required waterjet pressures were measured. Mean thickness of the samples tested within the 0.2 mm nozzle group was 2.3 mm (SD 0.7 mm) and within the 0.6 mm nozzle group 2.6 mm (SD 0.9 mm). The required waterjet pressure to cut samples was between 10 and 12 MPa for the 0.2 mm nozzle and between 5 and 10 MPa for the 0.6 mm nozzle. Cutting bone or bone cement requires about 3 times higher waterjet pressure (30-50 MPa, depending on used nozzle diameter) and therefore we consider waterjet cutting as a safe technique to be used for minimally invasive interface tissue removal.

Effect of Alkali-Acid-Heat Chemical Surface Treatment on Electron Beam Melted Porous Titanium and Its Apatite Forming Ability.

Advanced additive manufacturing techniques such as electron beam melting (EBM), can produce highly porous structures that resemble the mechanical properties and structure of native bone. However, for orthopaedic applications, such as joint prostheses or bone substitution, the surface must also be bio-functionalized to promote bone growth. In the current work, EBM porous Ti6Al4V alloy was exposed to an alkali acid heat (AlAcH) treatment to bio-functionalize the surface of the porous structure. Various molar concentrations (3, 5, 10M) and immersion times (6, 24 h) of the alkali treatment were used to determine optimal parameters. The apatite forming ability of the samples was evaluated using simulated body fluid (SBF) immersion testing. The micro-topography and surface chemistry of AlAcH treated samples were evaluated before and after SBF testing using scanning electron microscopy and energy dispersive X-ray spectroscopy. The AlAcH treatment successfully modified the topographical and chemical characteristics of EBM porous titanium surface creating nano-topographical features ranging from 200-300 nm in size with a titania layer ideal for apatite formation. After 1 and 3 week immersion in SBF, there was no Ca or P present on the surface of as manufactured porous titanium while both elements were present on all AlAcH treated samples except those exposed to 3M, 6 h alkali treatment. An increase in molar concentration and/or immersion time of alkali treatment resulted in an increase in the number of nano-topographical features per unit area as well as the amount of titania on the surface.

Mechanical properties of human bone-implant interface tissue in aseptically loose hip implants.

The main cause of failure in total hip replacement is aseptic loosening which is associated with the formation of a periprosthetic fibrous (interface) tissue. Despite important applications for finite element modeling of loose implants, the mechanical properties of the bone-implant interface tissue have never been measured in humans. In this study, we performed unconfined compression tests to characterize the mechanical properties of the interface tissue and to determine the parameters of various hyperelastic material models which were fitted to the measurements. Human interface tissues were retrieved during 21 elective revision surgeries from aseptically loosened cemented (N=10) and uncemented hip implants (N=11). Specimens were tested at a fixed deformation rate of 0.1mm/min up to a maximum force of 10N. Elastic moduli for low and high strain regions of the stress-strain curves were determined. Interface tissue from aseptically loose cemented prostheses shows higher elastic moduli (mean=1.85MPa, 95% C.I.=1.76-1.95MPa) in the high strain region as compared to that of the interface tissue from the cementless group (mean=1.65MPa, 95% C.I.=1.43-1.88MPa). The 5-terms Mooney-Rivlin model ( [Formula: see text] ) described the stress-strain behavior the best. Large variations in the mechanical behavior were observed both between specimens from the same patient as between those of different patients. The material model parameters were therefore estimated for the mean data as well as for the curves with the highest and lowest strain at the maximum load. The model parameters found for the mean data were C1=-0.0074MPa, C2=0.0019MPa, C3=0MPa, C4=-0.0032MPa and C5=0MPa in the cemented group and C1=-0.0137MPa, C2=0.0069MPa, C3=0.0026MPa, C4=-0.0094MPa and C5=0MPa in the cementless group. The results of this study can be used in finite element computer.

Percutaneous bone cement refixation of aseptically loose hip prostheses: the effect of interface tissue removal on injected cement volumes.

OBJECTIVE: To quantify whether injected cement volumes differed between two groups of patients who underwent experimental minimally invasive percutaneous cement injection procedures to stabilize aseptically loose hip prostheses. One patient group was preoperatively treated using gene-directed enzyme prodrug therapy to remove fibrous interface tissue, while the other group received no preoperative treatment. It was hypothesized that cement penetration may have been inhibited by the presence of fibrous interface tissue in periprosthetic lesions. MATERIALS AND METHODS: We analyzed 17 patients (14 female, 3 male, ages 72-91, ASA categories 2-4) who were treated at our institution. Osteolytic lesions and injected cement were manually delineated using 3D CT image segmentation, and the deposition of injected cement was quantified. RESULTS: Patients who underwent preoperative gene-directed enzyme therapy to remove fibrous tissue exhibited larger injected cement volumes than those who did not. The observed median increase in injected cement volume was 6.8 ml. Higher cement leakage volumes were also observed for this group. CONCLUSION: We conclude that prior removal of periprosthetic fibrous interface tissue may enable better cement flow and penetration. This might lead to better refixation of aseptically loosened prostheses.

Measuring polyethylene wear in total knee arthroplasty by RSA: differences between weight-bearing and non-weight-bearing positioning.

Measuring the minimum-joint-space-width (mJSW) in total knee arthroplasty (TKA) in Roentgen stereophotogrammetric analysis (RSA) provides valuable information on polyethylene wear, a leading cause for TKA failure. Most existing studies use non-weight-bearing (NWB) patient positioning. The latter may compromise mJSW measurements due to knee laxity with subsequent non-contact between the TKA components. We investigated the difference in mJSW between weight-bearing (WB) and NWB images and the association with mediolateral (ML) knee stability. At one-year follow-up, 23 TKAs were included from an ongoing RSA study, and ML stability was evaluated. For each examination, the mJSW and femoral-tibial contact locations were measured. A linear regression model was used to analyze the association between the mJSW difference (NWB-WB) with the ML stability and contact locations. The mean mJSW difference was 0.28 mm medially and 0.20 mm laterally. Four TKAs had medium (5-9°) and 19 TKAs had high (<5°) ML stability. A higher mJSW difference was found for TKAs with medium stability (0.36 mm, P = 0.01). In conclusion, mJSW measurements in existing (NWB) RSA studies are influenced by knee laxity, but may still provide information on wear progression based on TKA with high ML stability. A direct comparison of mJSW measurements from WB and NWB data is not possible.

Evaluation of automated statistical shape model based knee kinematics from biplane fluoroscopy.

State-of-the-art fluoroscopic knee kinematic analysis methods require the patient-specific bone shapes segmented from CT or MRI. Substituting the patient-specific bone shapes with personalizable models, such as statistical shape models (SSM), could eliminate the CT/MRI acquisitions, and thereby decrease costs and radiation dose (when eliminating CT). SSM based kinematics, however, have not yet been evaluated on clinically relevant joint motion parameters. Therefore, in this work the applicability of SSMs for computing knee kinematics from biplane fluoroscopic sequences was explored. Kinematic precision with an edge based automated bone tracking method using SSMs was evaluated on 6 cadaveric and 10 in-vivo fluoroscopic sequences. The SSMs of the femur and the tibia-fibula were created using 61 training datasets. Kinematic precision was determined for medial-lateral tibial shift, anterior-posterior tibial drawer, joint distraction-contraction, flexion, tibial rotation and adduction. The relationship between kinematic precision and bone shape accuracy was also investigated. The SSM based kinematics resulted in sub-millimeter (0.48-0.81mm) and approximately 1° (0.69-0.99°) median precision on the cadaveric knees compared to bone-marker-based kinematics. The precision on the in-vivo datasets was comparable to that of the cadaveric sequences when evaluated with a semi-automatic reference method. These results are promising, though further work is necessary to reach the accuracy of CT-based kinematics. We also demonstrated that a better shape reconstruction accuracy does not automatically imply a better kinematic precision. This result suggests that the ability of accurately fitting the edges in the fluoroscopic sequences has a larger role in determining the kinematic precision than that of the overall 3D shape accuracy.

Fixation of high-flexion total knee prostheses: five-year follow-up results of a four-arm randomized controlled clinical and roentgen stereophotogrammetric analysis study.

BACKGROUND: High-flexion total knee arthroplasty was introduced to meet the demands of daily activity requiring increased knee flexion. However, concerns have been raised regarding the fixation of high-flexion total knee arthroplasty components and increased rates of loosening have been reported. To date, migration, and thus fixation, of high-flexion total knee arthroplasty components has not been analyzed and the preferential bearing type (mobile or fixed) is unknown. METHODS: Of eighty-six consecutive eligible patients, seventy-four patients (seventy-eight knees) scheduled for total knee arthroplasty were randomized to one of four Legacy Posterior Stabilized (LPS) total knee prosthesis designs: (1) LPS-Flex mobile, (2) LPS-Flex fixed, (3) LPS mobile, and (4) LPS fixed. The primary outcome was component migration measured with use of Roentgen stereophotogrammetric analysis, and secondary outcomes were postoperative knee flexion and extension and Knee Society Score. Patients were evaluated postoperatively at six, twelve, twenty-six, and fifty-two weeks and annually thereafter. At the five-year follow-up, eight patients had died and two patients were lost to follow-up. Seventy-seven tibial and forty-two femoral components were suitable for migration measurements. RESULTS: The overall five-year migration of the seventy-seven tibial components was not significantly different among the four total knee prosthesis designs (compared with the LPS fixed design, the range of overall mean differences for the other three designs was 0.02 to 0.25 mm) and migration was comparable at the two and five-year follow-up. Migration stabilized in all but three components (two LPS-Flex mobile and one LPS fixed); one of these components has already been revised and was aseptically loose. The overall five-year migration of the forty-two femoral components was comparable among the four designs (compared with the LPS fixed design, the range of overall mean differences for the other three designs was 0.01 to 0.18 mm) and was similar at two and five years postoperatively. One femoral component (LPS-Flex mobile) migrated excessively. In patients who had a mean postoperative flexion of ≥ 125° or a maximum flexion of ≥ 135° during the one to five-year follow-up period, migration of high-flexion components was comparable with that of conventional components and indicative of appropriate fixation. Postoperative flexion, extension, Knee Society Score, and Knee Society Score function were comparable during the five-year follow-up period and at the two and five-year follow-up. CONCLUSIONS: The LPS-Flex total knee prosthesis with either a mobile or a fixed bearing had migration comparable that of with its conventional counterpart and is expected to have similar (excellent) long-term survival in these patients. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.