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.     

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.     

Digital automated RSA compared to manually operated RSA

The accuracy of digital Roentgen stereophotogrammetric analysis (RSA) was compared to the accuracy of a manually operated RSA system. For this purpose, we used radiographs of a phantom and radiographs of patients. The radiographs of the patients consisted of double examinations of 12 patients that had a tibial osteotomy and of double examinations of 12 patients that received a total hip prosthesis. First, the radiographs were measured manually with an accurate measurement table. Subsequently, the images were digitized by a film scanner at 150 DPI and 300 DPI resolutions and analyzed with the RSA-CMS software. In the phantom experiment, the manually operated system produced significantly better results than the digital system, although the maximum difference between the median values of the manually operated system and the digital system was as low as 0.013 mm for translations and 0.033° for rotations. In the radiographs of the patients, the manually operated system and the digital system produced equally accurate results: no significant differences in translations and rotations were found. We conclude that digital RSA is an accurate, fast, and user friendly alternative for manually operated RSA. Currently, digital RSA systems are being used in a growing number of clinical RSA-studies.     

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.     

Markerless Roentgen Stereophotogrammetric Analysis for in vivo implant migration measurement using three dimensional surface models to represent bone

Recent studies have shown that model-based RSA using implant surface models to detect in vivo migration is as accurate as the classical marker-based RSA method. Use of bone surface models would be a further advancement of the model-based method by decreasing complications arising from marker insertion. The aim of this pilot investigation was to assess the feasibility of a "completely markerless" model-based RSA in detecting migration of an implant using bone surface models instead of bone markers. A total knee arthroplasty (TKA) was performed on a human cadaver knee, which was subsequently investigated by repeated RSA measurements performed by one observer. The cadaver knee was CT scanned prior to implantation of the TKA. Tibia-fibular surface models were created using two different commercially available software packages to investigate the effect of segmentation software on the accuracy of repeated migration measures of zero displacement by one observer. Reverse engineered surface models of the TKA tibial component were created. The analysis of the RSA images was repeated 10 times by one individual observer. For the markerless method, the greatest apparent migration observed about the three anatomical axes investigated was between -2.08 and 1.35 mm (SD ≤ 0.88) for z-axis translation, and -4.57° to 7.86° (SD ≤ 3.17) for R(y)-axis rotation, which were well beyond out of the range of what is typically considered adequate for clinically relevant RSA measurements. Use of tibia-fibular surface models of the bone instead of markers could provide practical advantages in evaluating implant migration. However, we found the accuracy and precision of the markerless approach to be lower than that of marker-based RSA, to a degree which precludes the use of this method for measuring implant migration in its present form.     

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.     

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.     

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.     

Model-based Roentgen stereophotogrammetry of orthopaedic implants

Attaching tantalum markers to prostheses for Roentgen stereophotogrammetry (RSA) may be difficult and is sometimes even impossible. In this study, a model-based RSA method that avoids the attachment of markers to prostheses is presented and validated. This model-based RSA method uses a triangulated surface model of the implant. A projected contour of this model is calculated and this calculated model contour is matched onto the detected contour of the actual implant in the RSA radiograph. The difference between the two contours is minimized by variation of the position and orientation of the model. When a minimal difference between the contours is found, an optimal position and orientation of the model has been obtained. The method was validated by means of a phantom experiment. Three prosthesis components were used in this experiment: the femoral and tibial component of an Interax total knee prosthesis (Stryker Howmedica Osteonics Corp., Rutherfort, USA) and the femoral component of a Profix total knee prosthesis (Smith & Nephew, Memphis, USA). For the prosthesis components used in this study, the accuracy of the model-based method is lower than the accuracy of traditional RSA. For the Interax femoral and tibial components, significant dimensional tolerances were found that were probably caused by the casting process and manual polishing of the components surfaces. The largest standard deviation for any translation was 0.19mm and for any rotation it was 0.52 degrees. For the Profix femoral component that had no large dimensional tolerances, the largest standard deviation for any translation was 0.22mm and for any rotation it was 0.22 degrees. From this study we may conclude that the accuracy of the current model-based RSA method is sensitive to dimensional tolerances of the implant. Research is now being conducted to make model-based RSA less sensitive to dimensional tolerances and thereby improving its accuracy.     

Validation of a low-dose hybrid RSA and fluoroscopy technique: Determination of accuracy, bias and precision

Analyzing skeletal kinematics with radiostereometric analysis (RSA) following corrective orthopedic surgery allows the quantitative comparison of different implant designs. The purpose of this study was to validate a technique for dynamically estimating the relative position and orientation of skeletal segments using RSA and single plane X-ray fluoroscopy. Two micrometer-based in vitro phantom models of the skeletal segments in the hip and knee joints were used. The spatial positions of tantalum markers that were implanted into each skeletal segment were reconstructed using RSA. The position and orientation of each segment were determined in fluoroscopy images by minimizing the difference between the markers measured and projected in the image plane. Accuracy was determined in terms of bias and precision by analyzing the deviation between the applied displacement protocol and measured pose estimates. Measured translational accuracy was less than 100 microm parallel to the image plane and less than 700 microm in the direction orthogonal to the image plane. The measured rotational error was less than 1 degrees . Measured translational and rotational bias was not statistically significant at the 95% level of confidence. The technique allows real-time kinematic skeletal measurements to be performed on human subjects implanted with tantalum markers for quantitatively measuring the motion of normal joints and different implant designs.     

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.     

In-vivo measurement of dynamic joint motion using high speed biplane radiography and CT: application to canine ACL deficiency

Dynamic assessment of three-dimensional (3D) skeletal kinematics is essential for understanding normal joint function as well as the effects of injury or disease. This paper presents a novel technique for measuring in-vivo skeletal kinematics that combines data collected from high-speed biplane radiography and static computed tomography (CT). The goals of the present study were to demonstrate that highly precise measurements can be obtained during dynamic movement studies employing high frame-rate biplane video-radiography, to develop a method for expressing joint kinematics in an anatomically relevant coordinate system and to demonstrate the application of this technique by calculating canine tibio-femoral kinematics during dynamic motion. The method consists of four components: the generation and acquisition of high frame rate biplane radiographs, identification and 3D tracking of implanted bone markers, CT-based coordinate system determination, and kinematic analysis routines for determining joint motion in anatomically based coordinates. Results from dynamic tracking of markers inserted in a phantom object showed the system bias was insignificant (-0.02 mm). The average precision in tracking implanted markers in-vivo was 0.064 mm for the distance between markers and 0.31 degree for the angles between markers. Across-trial standard deviations for tibio-femoral translations were similar for all three motion directions, averaging 0.14 mm (range 0.08 to 0.20 mm). Variability in tibio-femoral rotations was more dependent on rotation axis, with across-trial standard deviations averaging 1.71 degrees for flexion/extension, 0.90 degree for internal/external rotation, and 0.40 degree for varus/valgus rotation. Advantages of this technique over traditional motion analysis methods include the elimination of skin motion artifacts, improved tracking precision and the ability to present results in a consistent anatomical reference frame.     

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.     

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.     

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.     

Main component of soft tissue artifact of the upper-limbs with respect to different functional,daily life and sports movements

Soft tissue artifact (STA) is the main source of error in kinematic estimation of human movements based on skin markers. Our objective was to determine the components of marker displacements that best describe STA of the shoulder and arm (i.e. clavicle, scapula and humerus). Four participants performed arm flexion and rotation, a daily-life and a sports movement. Three pins with reflective markers were inserted into the clavicle, scapula and humerus. In addition, up to seven skin markers were stuck on each segment. STA was described with a modal approach: individual marker displacements or marker-cluster (i.e. translations, rotations, homotheties and stretches) relative to the local segment coordinate system defined by markers secured to the pins. The modes were then ranked according to the percentage of total STA energy that they explained. Both individual skin marker displacements and marker-cluster geometrical transformations were task-, location-, segment- and subject-specific. However, 85% of the total STA energy was systematically explained by the rigid transformations (i.e. translations and rotations of the marker-cluster). In conclusion, large joint dislocations and limited efficiency of least squares bone pose estimators are expected for the computation of upper limb joint kinematics from skin markers. Future developments shall consider the rigid transformations of marker-clusters in the implementation of an STA model to reduce its effects on kinematics estimation.     

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.     

Verification of predicted specimen-specific natural and implanted patellofemoral kinematics during simulated deep knee bend

Verified computational models represent an efficient method for studying the relationship between articular geometry, soft-tissue constraint, and patellofemoral (PF) mechanics. The current study was performed to evaluate an explicit finite element (FE) modeling approach for predicting PF kinematics in the natural and implanted knee. Experimental three-dimensional kinematic data were collected on four healthy cadaver specimens in their natural state and after total knee replacement in the Kansas knee simulator during a simulated deep knee bend activity. Specimen-specific FE models were created from medical images and CAD implant geometry, and included soft-tissue structures representing medial–lateral PF ligaments and the quadriceps tendon. Measured quadriceps loads and prescribed tibiofemoral kinematics were used to predict dynamic kinematics of an isolated PF joint between 10° and 110° femoral flexion. Model sensitivity analyses were performed to determine the effect of rigid or deformable patellar representations and perturbed PF ligament mechanical properties (pre-tension and stiffness) on model predictions and computational efficiency.Predicted PF kinematics from the deformable analyses showed average root mean square (RMS) differences for the natural and implanted states of less than 3.1° and 1.7 mm for all rotations and translations. Kinematic predictions with rigid bodies increased average RMS values slightly to 3.7° and 1.9 mm with a five-fold decrease in computational time. Two-fold increases and decreases in PF ligament initial strain and linear stiffness were found to most adversely affect kinematic predictions for flexion, internal–external tilt and inferior–superior translation in both natural and implanted states. The verified models could be used to further investigate the effects of component alignment or soft-tissue variability on natural and implant PF mechanics.     

Validation of radiostereometric analysis in six degrees of freedom for use with reverse total shoulder arthroplasty

A phantom study was conducted to determine bias in motion and bias at zero motion of radiostereometric analysis (RSA) for evaluating implant relative displacement in reverse total shoulder arthroplasty (RTSA). A Sawbones shoulder phantom was fitted with a RTSA implant set and 13 tantalum markers. The model was fixed to a manual micrometer, providing controlled movements though fifteen known increments in translation and twelve increments in rotation (0.02–5.00 mm and 0.1–6.0°), along each translation and rotation axis. Movement between the glenoid and humerus was assessed using beads vs. beads (B/B), model vs. beads (M/B), and model vs. model (M/M) measurement methods in a model-based RSA environment. Bias in motion and bias at zero motion were defined as the difference between measured and accepted reference values, and the difference between double examinations with a theoretical displacement of zero, respectively. Bias in motion ranged from 0.054 ± 0.010 to 0.129 ± 0.014 mm and 0.076 ± 0.025 to 0.126 ± 0.025° (B/B), 0.023 ± 0.009 to 0.126 ± 0.016 mm and 0.111 ± 0.033 to 0.794 ± 0.251° (M/B), and 0.029 ± 0.010 to 0.135 ± 0.030 mm and 0.243 ± 0.088 to 0.384 ± 0.153° (M/M). Bias at zero motion ranged from 0.120 to 0.156 mm and 0.075 to 0.206° (B/B), 0.074 to 0.149 mm and 0.067 to 1.953° (M/B), and 0.069 to 0.259 mm and 0.284 to 1.273° (M/M). This is the first RSA for RTSA study, with results comparable to those validating the use of RSA for hip and knee arthroplasties (accepted as 0.05–0.50 mm and 0.15–1.15°), justifying the potential use of RSA as a tool for measuring implant displacement in the shoulder.