Implementation and validation of an implant-based coordinate system for RSA migration calculation

An in vitro radiostereometric analysis (RSA) phantom study of a total knee replacement was carried out to evaluate the effect of implementing two new modifications to the conventional RSA procedure: (i) adding a landmark of the tibial component as an implant marker and (ii) defining an implant-based coordinate system constructed from implant landmarks for the calculation of migration results. The motivation for these two modifications were (i) to improve the representation of the implant by the markers by including the stem tip marker which increases the marker distribution (ii) to recover clinical RSA study cases with insufficient numbers of markers visible in the implant polyethylene and (iii) to eliminate errors in migration calculations due to misalignment of the anatomical axes with the RSA global coordinate system. The translational and rotational phantom studies showed no loss of accuracy with the two new measurement methods. The RSA system employing these methods has a precision of better than 0.05 mm for translations and 0.03° for rotations, and an accuracy of 0.05 mm for translations and 0.15° for rotations. These results indicate that the new methods to improve the interpretability, relevance, and standardization of the results do not compromise precision and accuracy, and are suitable for application to clinical data.     

Image-based RSA: Roentgen stereophotogrammetric analysis based on 2D-3D image registration

Image-based Roentgen stereophotogrammetric analysis (IBRSA) integrates 2D-3D image registration and conventional RSA. Instead of radiopaque RSA bone markers, IBRSA uses 3D CT data, from which digitally reconstructed radiographs (DRRs) are generated. Using 2D-3D image registration, the 3D pose of the CT is iteratively adjusted such that the generated DRRs resemble the 2D RSA images as closely as possible, according to an image matching metric. Effectively, by registering all 2D follow-up moments to the same 3D CT, the CT volume functions as common ground. In two experiments, using RSA and using a micromanipulator as gold standard, IBRSA has been validated on cadaveric and sawbone scapula radiographs, and good matching results have been achieved. The accuracy was: |mu |< 0.083 mm for translations and |mu| < 0.023 degrees for rotations. The precision sigma in x-, y-, and z-direction was 0.090, 0.077, and 0.220 mm for translations and 0.155 degrees , 0.243 degrees , and 0.074 degrees for rotations. Our results show that the accuracy and precision of in vitro IBRSA, performed under ideal laboratory conditions, are lower than in vitro standard RSA but higher than in vivo standard RSA. Because IBRSA does not require radiopaque markers, it adds functionality to the RSA method by opening new directions and possibilities for research, such as dynamic analyses using fluoroscopy on subjects without markers and computer navigation applications.     

A new model-based RSA method validated using CAD models and models from reversed engineering

Roentgen stereophotogrammetric analysis (RSA) was developed to measure micromotion of an orthopaedic implant with respect to its surrounding bone. A disadvantage of conventional RSA is that it requires the implant to be marked with tantalum beads. This disadvantage can potentially be resolved with model-based RSA, whereby a 3D model of the implant is used for matching with the actual images and the assessment of position and rotation of the implant. In this study, a model-based RSA algorithm is presented and validated in phantom experiments. To investigate the influence of the accuracy of the implant models that were used for model-based RSA, we studied both computer aided design (CAD) models as well as models obtained by means of reversed engineering (RE) of the actual implant. The results demonstrate that the RE models provide more accurate results than the CAD models. If these RE models are derived from the very same implant, it is possible to achieve a maximum standard deviation of the error in the migration calculation of 0.06 mm for translations in x- and y-direction and 0.14 mm for the out of plane z-direction, respectively. For rotations about the y-axis, the standard deviation was about 0.1 degrees and for rotations about the x- and z-axis 0.05 degrees. Studies with clinical RSA-radiographs must prove that these results can also be reached in a clinical setting, making model-based RSA a possible alternative for marker-based RSA.     

Precision measurements of the RSA method using a phantom model of hip prosthesis

Radiostereometric analysis (RSA) has become one of the recommended techniques for pre-market evaluation of new joint implant designs. In this study we evaluated the effect of repositioning of X-ray tubes and phantom model on the precision of the RSA method. In precision measurements, we utilized mean error of rigid body fitting (ME) values as an internal control for examinations. ME value characterizes relative motion among the markers within each rigid body and is conventionally used to detect loosening of a bone marker. Three experiments, each consisting of 10 double examinations, were performed. In the first experiment, the X-ray tubes and the phantom model were not repositioned between one double examination. In experiments two and three, the X-ray tubes were repositioned between one double examination. In addition, the position of the phantom model was changed in experiment three. Results showed that significant differences could be found in 2 of 12 comparisons when evaluating the translation and rotation of the prosthetic components. Repositioning procedures increased ME values mimicking deformation of rigid body segments. Thus, ME value seemed to be a more sensitive parameter than migration values in this study design. These results confirmed the importance of standardized radiographic technique and accurate patient positioning for RSA measurements. Standardization and calibration procedures should be performed with phantom models in order to avoid unnecessary radiation dose of the patients. The present model gives the means to establish and to follow the intra-laboratory precision of the RSA method. The model is easily applicable in any research unit and allows the comparison of the precision values in different laboratories of multi-center trials.     

Comparative accuracy of radiostereometric and optical tracking systems

This study aims to quantify and compare the accuracy of traditional radiostereometric analysis (RSA), fluoroscopic RSA (fRSA), and optical tracking systems. Three phantoms were constructed, each having three stainless steel spheres and three reflective markers. One phantom was mounted to the base of a precision cross-slide table, one to the base of a precision rotation table, and the third was mounted to each moveable tabletop. Two dial-gauges, rigidly mounted to the cross-slide table and rotation table, quantified translations and rotations. Two fluoroscopy units placed orthogonally tracked the steel spheres while a four-camera optical motion capture system tracked the reflective markers in three-dimensional space. RSA was performed with both digital radiography and fluoroscopy. Three axes of translation were tested: parallel to one fluoroscopy image, parallel to the other fluoroscopy image, and at approximately 45° to each image. One axis of rotation was tested. Intraclass correlation coefficients indicated excellent agreement between the actual (dial-gauge) and measured translations for all modalities (ICCs>0.99) and excellent agreement between actual and measured rotations for RSA and fRSA (ICCs>0.99). Standard errors of measurement ranged from 0.032 mm and 0.121° for RSA, to 0.040 mm and 0.229° for fRSA, and to 0.109 mm and 0.613° for optical tracking. Differences between actual and measured translations along the 45° axis were significantly smaller than the two parallel axes. These findings suggest that under ideal conditions, accuracy of fRSA is comparable to traditional RSA, and superior to optical tracking. Accuracy is highest when measured at 45° to the fluoroscopy units.     

The precision of radiostereometric measurements. Manual vs. digital measurements.

The precision of digital vs. manual radiostereometric measurements in total hip arthroplasty was evaluated using repeated stereoradiographic exposures with an interval of 10-15 min. Ten Lubinus SP2 stems cemented into bone specimens and 12 patients with the same stem design were used to evaluate the precision of stem translations and rotations. The precision of translations and rotations of the cup and femoral head penetration was studied in 12 patients with whole polyethylene cups.The use of a measurement method based on digitised radiographs improved the precision for some of the motion parameters, whereas many of them did not change. A corresponding pattern was observed for both the intra- and interobserver error. Of the wear parameters, the most pronounced improvements were the 3D wear and in the proximal-distal direction, although the anterior-posterior precision was also improved. The mean errors of rigid body and elliptic fitting decreased in all evaluations but one, consistent with a more reproducible identification of the markers centres and the edge of the femoral head.Increased precision of radiostereometric measurements may be used to increase the statistical power of future randomised studies and to study new fields in orthopaedics requiring higher precision than has been available with RSA based on manual measurements.     

Three-dimensional computer simulation of radiostereometric analysis (RSA) in distal radius fractures

Physical phantom models have conventionally been used to determine the accuracy and precision of radiostereometric analysis (RSA) in various orthopaedic applications. Using a phantom model of a fracture of the distal radius it has previously been shown that RSA is a highly accurate and precise method for measuring both translation and rotation in three-dimensions (3-D). The main shortcoming of a physical phantom model is its inability to mimic complex 3-D motion. The goal of this study was to create a realistic computer model for preoperative planning of RSA studies and to test the accuracy of RSA in measuring complex movements in fractures of the distal radius using this new model. The 3-D computer model was created from a set of tomographic scans. The simulation of the radiographic imaging was performed using ray-tracing software (POV-Ray). RSA measurements were performed according to standard protocol. Using a two-part fracture model (AO/ASIF type A2), it was found that for simple movements in one axis, translations in the range of 25microm-2mm could be measured with an accuracy of +/-2microm. Rotations ranging from 16 degrees to 2 degrees could be measured with an accuracy of +/-0.015 degrees . Using a three-part fracture model the corresponding values of accuracy were found to be +/-4microm and +/-0.031 degrees for translation and rotation, respectively. For complex 3-D motion in a three-part fracture model (AO/ASIF type C1) the accuracy was +/-6microm for translation and +/-0.120 degrees for rotation. The use of 3-D computer modelling can provide a method for preoperative planning of RSA studies in complex fractures of the distal radius and in other clinical situations in which the RSA method is applicable.     

RSA wear measurements with or without markers in total hip arthroplasty

Novel algorithms for radiostereometric (RSA) measurements of the femoral head and metal-backed, hemi-spherical cups of a total hip replacement are presented and evaluated on phantom images and clinical double examinations of 20 patients. The materials were analysed with classical RSA and three novel algorithms: (1) a dual-projection head algorithm using the outline of the femoral head together with markers in the cup; (2) a marker-less algorithm based on measurements of the outline of the femoral head, the cup shell and opening circle of the cup; and (3) a combination of both methods. The novel algorithms improve current, marker-based, RSA measurements, as well as allows studies without marked cups. This opens the possibility of performing wear measurements on larger group of patients, in clinical follow-ups, even retrospective studies. The novel algorithms may help to save patient data in current RSA studies lost due to insufficiently marked cups. Finally, the novel algorithms simplify the RSA procedure and allow new studies without markers, saving time, money, and reducing safety concerns. Other potential uses include migration measurements of re-surfacing heads and measuring spherical sections as implant landmarks instead of markers.     

Imaging knee position using MRI, RSA/CT and 3D digitisation

The purpose of this study was to compare 3 methods of imaging knee position. Three fresh cadaver knees were imaged at 6 flexion angles between 0 degrees and 120 degrees by MRI, a combination of RSA and CT and 3D digitisation (in two knees). Virtual models of all 42 positions were created using suitable computer software. Each virtual model was aligned to a newly defined anatomically based Cartesian coordinate system. The angular rotations around the 3 coordinate system axes were calculated directly from the aligned virtual models using rigid body kinematics and found to be equally accurate for the 3 methods. The 3 rotations in each knee could be depicted using anatomy-based diagrams for all 3 methods. We conclude that the 3 methods of data acquisition are equally and adequately accurate in vitro. MRI may be the most useful in vivo.     

Development of an RSA calibration system with improved accuracy and precision

In this study, a new radiostereometric analysis (RSA) calibration cage was developed with the aim of improving the accuracy and precision of RSA. This development consisted of three steps: a numerical simulation technique was first used to design the new cage; a synthetic imaging method was then implemented to predict the performance of the designed cage before it was actually fabricated; and an experimental phantom test was finally conducted to verify the actual performance of the new cage and compare with two currently widely used cages. Accuracy was calculated as the 95% prediction intervals from regression analyses between the measured and actual displacements, and precision was defined as the standard deviation of repeated measurements. The final experimental phantom tests showed that the accuracy and precision of the new calibration cage were improved by about 40% over an existing biplanar cage and by about 70% compared to a uniplanar cage design. This new cage can be used with any skeletal joints, in either static or kinematic examination, which is helpful for the standardization of the RSA application.     

Handling modular hip implants in model-based RSA: combined stem-head models

Migration measurements of hip prostheses using marker-based Roentgen stereophotogrammetric analysis (RSA) require the attachment of markers to the prostheses. The model-based approach, which does not require these markers, is, however, less precise. One of the reasons may be the fact that the spherical head has not been modelled. Therefore, we added a 3D surface model of the spherical head and estimated the position and orientation of the combined stem-head model. The new method using a combined stem-head model was compared in a phantom study on five prostheses (of different types) and in a clinical study using double examinations of implanted hip prostheses, with two existing methods: a standard model-based approach and one using elementary geometrical shapes. The combined model showed the highest precision for the rotation about the longitudinal axis in the phantom experiments. With a standard deviation of 0.69 degrees it showed a significant improvement (p=0.02) over the model-based approach (0.96 degrees ) on the phantom data, but no improvement on the clinical data. Overall, the use of elementary geometrical shapes was worse with respect to the model-based approach, with a standard deviation of 1.02 degrees on the phantom data and 0.79 degrees on the clinical data. This decrease in precision was significant (p<0.01) on the clinical data. With relatively small differences in the other migration directions, these results demonstrate that the new method with a combined stem-head model can be a useful alternative to the standard model-based approach.     

Radiostereometric analysis using clinical radiographic views: Development of a universal calibration object

Radiostereometric analysis (RSA) is a highly accurate technique used to provide three-dimensional (3D) measurements of orthopaedic implant migration for clinical research applications, yet its implementation in routine clinical examinations has been limited. Previous studies have introduced a modified RSA procedure that separates the calibration examinations from the patient examinations, allowing routine clinical radiographs to be analyzed using RSA. However, in order to calibrate the wide range of clinical views, a new calibration object is required. In this study, a universal, isotropic calibration object was designed to calibrate any pair of radiographic views used in the clinic for RSA. A numerical simulation technique was used to design the calibration object, followed by a phantom validation test of a prototype to verify the performance of the novel object, and to compare the measurement reliability to the conventional calibration cage. The 3D bias for the modified calibration method using the new calibration object was 0.032 ± 0.006 mm, the 3D repeatability standard deviation was 0.015 mm, and the 3D repeatability limit was 0.042 mm. Although statistical differences were present between the universal calibration object and the conventional cage, the differences were considered to be not clinically meaningful. The 3D bias and repeatability values obtained using the universal calibration object were well under the threshold acceptable for RSA, therefore it was successfully validated. The universal calibration object will help further the adoption of RSA into a more routine practice, providing the opportunity to generate quantitative databases on joint replacement performance.     

Development of an x-ray-opaque-marker system for quantitative phantom positioning in patient-specific quality assurance

PurposeWe developed an x-ray-opaque-marker (XOM) system with inserted fiducial markers for patient-specific quality assurance (QA) in CyberKnife (Accuray) and a general-purpose linear accelerator (linac). The XOM system can be easily inserted or removed from the existing patient-specific QA phantom. Our study aimed to assess the utility of the XOM system by evaluating the recognition accuracy of the phantom position error and estimating the dose perturbation around a marker.MethodsThe recognition accuracy of the phantom position error was evaluated by comparing the known error values of the phantom position with the values measured by matching the images with target locating system (TLS; Accuray) and on-board imager (OBI; Varian). The dose perturbation was evaluated for 6 and 10 MV single-photon beams through experimental measurements and Monte Carlo simulations.ResultsThe root mean squares (RMSs) of the residual position errors for the recognition accuracy evaluation in translations were 0.07 mm with TLS and 0.30 mm with OBI, and those in rotations were 0.13° with TLS and 0.15° with OBI. The dose perturbation was observed within 1.5 mm for 6 MV and 2.0 mm for 10 MV from the marker.ConclusionsSufficient recognition accuracy of the phantom position error was achieved using our system. It is unnecessary to consider the dose perturbation in actual patient-specific QA. We concluded that the XOM system can be utilized to ensure quantitative and accurate phantom positioning in patient-specific QA with CyberKnife and a general-purpose linac.     

Improved RSA accuracy with DLT and balanced calibration marker distributions with an assessment of initial-calibration

Roentgen stereophotogrammetric analysis (RSA) has been used for over 25 years for accurate micromotion measurement in a wide variety of orthopaedic applications. This study investigated two possible improvements to the method. First, direct linear transformation (DLT) was compared to the traditional RSA reconstruction algorithm. The two methods were considered with respect to standard extrapolation and interpolation calibration cages. Matlab simulations showed that reconstruction accuracy was greatly improved (>60%) by combining DLT with an even distribution of enclosing calibration markers. Second, a benchtop study using phantoms translated at 0.0254-mm intervals showed initial-calibration, followed by removal of the interpolation cage for subsequent exposures, was potentially twice as accurate as self-calibration with an extrapolation cage. These results showed optimizations for the application of RSA when unobstructed space is required.     

Accuracy and repeatability of Roentgen stereophotogrammetric analysis (RSA) for measuring knee laxity in longitudinal studies

Roentgen stereophotogrammetric analysis (RSA) can be used to assess temporal changes in anterior-posterior (A-P) knee laxity. However, the accuracy and precision of RSA is dependent on many factors and should be independently evaluated for a particular application. The objective of this study was to evaluate the use of RSA for measuring A-P knee laxity. The specific aims were to assess the variation or "noise" inherent to RSA, to determine the reproducibility of RSA for repeated A-P laxity testing, and to assess the accuracy of these measurements. Two experiments were performed. The first experiment utilized three rigid models of the tibiofemoral joint to assess the noise and to compare digitization errors of two independent examiners. No differences were found in the kinematic outputs of the RSA due to examiner, repeated trials, or the model used. In a second experiment, A-P laxity values between the A-P shear load limits of +/-60 N of five cadaver goat knees were measured to assess the error associated with repeated testing. The RSA laxity values were also compared to those obtained from a custom designed linkage system. The mean A-P laxity values with the knee 30 degrees, 60 degrees, and 90 degrees of flexion for the ACL-intact goat knee (+/-95% confidence interval) were 0.8 (+/-0.25), 0.9 (+/-0.29), and 0.4 (+/-0.22) mm, respectively. In the ACL-deficient knee, the A-P laxity values increased by an order of magnitude to 8.8 (+/-1.39), 7.6 (+/-1.32), and 3.1 (+/-1.20)mm, respectively. No significant differences were found between the A-P laxity values measured by RSA and the independent measurement technique. A highly significant linear relationship (r(2)=0.83) was also found between these techniques. This study suggests that the RSA method is an accurate and precise means to measure A-P knee laxity for repeated testing over time.     

A simplified radiographic method for measuring bone-component motion in total knees.

Measurement of the relative motion between an implant and the surrounding bone over different time periods is valuable for assessing and comparing the component stability and predicting the potential future outcome. The RSA method, where small beads are implanted in the bone adjacent to the component, can measure implant-bone position to an accuracy of about 0.1 mm. However, the method involves special radiographic views and analytical software, not readily available. For purposes of component assessment on a more routine basis and for multi-centre trials, a method was developed where standard A-P and M-L radiographs were used. Computer software was written which estimated the out-of-plane rotations of the component relative to the plane of the film, and then carried out corrections to enhance the accuracy of calculation of the bead heights relative to the component. The theoretical errors were shown to be less than 0.04 mm for the expected range of out-of-plane rotations. When radiographs of components in simulated bones were taken at a range of rotations, the 95% confidence limits for axial displacement were found to be less than +0.3 mm, and for rotation in the plane to be 0.6 degrees. This indicated that the method was useful for studying knee components where the sinkage could reach a range of 0.5-2 mm in a 2 year period.     

The robustness and accuracy of in vivo linear wear measurements for knee prostheses based on model-based RSA

Accurate in vivo measurements methods of wear in total knee arthroplasty are required for a timely detection of excessive wear and to assess new implant designs. Component separation measurements based on model-based Roentgen stereophotogrammetric analysis (RSA), in which 3-dimensional reconstruction methods are used, have shown promising results, yet the robustness of these measurements is unknown. In this study, the accuracy and robustness of this measurement for clinical usage was assessed. The validation experiments were conducted in an RSA setup with a phantom setup of a knee in a vertical orientation. 72 RSA images were created using different variables for knee orientations, two prosthesis types (fixed-bearing Duracon knee and fixed-bearing Triathlon knee) and accuracies of the reconstruction models. The measurement error was determined for absolute and relative measurements and the effect of knee positioning and true seperation distance was determined. The measurement method overestimated the separation distance with 0.1mm on average. The precision of the method was 0.10mm (2*SD) for the Duracon prosthesis and 0.20mm for the Triathlon prosthesis. A slight difference in error was found between the measurements with 0° and 10° anterior tilt. (difference=0.08mm, p=0.04). The accuracy of 0.1mm and precision of 0.2mm can be achieved for linear wear measurements based on model-based RSA, which is more than adequate for clinical applications. The measurement is robust in clinical settings. Although anterior tilt seems to influence the measurement, the size of this influence is low and clinically irrelevant.     

改进底物添加体系制备氢化可的松

在蓝色梨头霉和新月弯孢霉协同转化制备氢化可的松(HC)过程中,常规的底物热溶液体系由17α羟基孕甾4-烯-3,20-二酮-21-醋酸酯(RSA)和乙醇组成,其中m(RSA)∶V(乙醇)=1∶25;改进后的底物溶液体系由Tween-80、丙三醇、RSA和磷酸盐缓冲溶液(PBS)组成,其中V(Tween-80)∶V(丙三醇)∶m(RSA)∶V(PBS)=1∶3∶1∶25。RSA质量浓度从2g/L起,累加到5g/L,RSA全部被转化,且产物氢化可的松(HC)产率与常规低浓度投料相当;在RSA质量浓度3g/L时添加底物,协同菌丝体能重复利用达3次,HC产率稳定在70%左右;经3批次实验室摇瓶放大制备实验,产物HC平均收率为52%,重现性较好,工艺操作稳定。Tween-80/丙三醇/RSA/PBS底物体系较常规RSA/乙醇构成的底物添加体系,可显著提高HC生产收率,有工业应用价值。     

A new type of model-based Roentgen stereophotogrammetric analysis for solving the occluded marker problem

Roentgen stereophotogrammetric analysis (RSA) measures micromotion of an orthopaedic implant with respect to its surrounding bone. A problem in RSA is that the markers are sometimes overprojected by the implant itself. This study describes the so-called Marker Configuration Model-based RSA (MCM-based RSA) that is able to measure the pose of a rigid body in situations where less than three markers could be detected in both images of an RSA radiograph. MCM-based RSA is based on fitting a Marker Configuration model (MC-model) to the projection lines from the marker projection positions in the image to their corresponding Roentgen foci. An MC-model describes the positions of markers relative to each other and is obtained using conventional RSA. We used data from 15 double examinations of a clinical study of total knee prostheses and removed projections of the three tibial component markers, simulating occlusion of markers. The migration of the tibial component with respect to the bone, which should be zero, for the double examination is a measure of the accuracy of algorithm. With the new algorithm, it is possible to estimate the pose of a rigid body of which one or two markers are occluded in one of the images of the RSA radiograph with high accuracy as long as a proper MC-model of the markers in the rigid body is available. The new algorithm makes RSA more robust for occlusion of markers. This improves the results of clinical RSA studies because the number of lost RSA follow-up moments is reduced.     

Analysis of humeral head displacements from sequences of biplanar X-rays: repeatability study and preliminary results in healthy subjects

This work presents an accurate method to measure gleno-humeral translations in a controlled pseudo-kinematic environment. Low-dose biplanar X-rays were acquired from nine healthy subjects at three elevations of the arm in the scapular plane. On each set of images, shoulder bony landmarks were manually located in 3D using a dedicated software. Intra-observer and inter-observer repeatability of landmark identification, as well as humeral head center (GH) translations, were studied. Repeatability for the identification of GH in the global coordinate system (CS) was good with 95% confidence intervals (CIs) ranging from 0.57 to 2.25 mm. Scapular landmark CIs ranged from 0.80 to 12 mm. Gleno-humeral translations of small amplitude ( < 6 mm) were detected in seven out of nine subjects. The results obtained here confirm that calibrated low-dose stereo-radiography is a promising tool for the functional analysis of the shoulder.