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.

No increased migration in cups with ceramic-on-ceramic bearing: an RSA study.

UNLABELLED: Ceramic-on-ceramic hip replacements might stress the bone interface more than a metal-polyethylene because of material stiffness, microseparation, and sensitivity to impingement. To ascertain whether this potentially increased stress caused an increased cup migration we compared a ceramic-on-ceramic with a metal-on-polyethylene implant for cup migration. Sixty one patients (61 hips) undergoing THA for osteoarthritis were randomized to ceramic on ceramic (Ce/Ce) or cobalt-chromium on cross-linked polyethylene bearings (PE) in the same uncemented cup shell. Migration was followed with RSA. At 2 years we observed similar mean cup translations in the 3 directions (0.07-0.40 mm vs. 0.05-0.31 mm, Ce/Ce vs. PE), as well as similar rotations around the 3 axes (0.31-0.92 degrees vs. 0.57-1.40 degrees). WOMAC and SF-36 scores were also similar and no radiolucent lines or osteolysis found. The large migration seen in some cups in both implant groups will require close monitoring to ascertain the reasons. Mean proximal wear of the polyethylene liners measured 0.016 mm between 2 and 24 months. Our data suggest there is no increased cup migration in the ceramic-on-ceramic implant compared with the metal-on-polyethylene, and they seem an equally safe choice. However, the low wear measured with the more versatile and less expensive cross-linked polyethylene makes it a strong contender. LEVELS OF EVIDENCE: Therapeutic Level I. See the Guidelines for Authors for a complete description of levels of evidence.

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.

Guidelines for standardization of radiostereometry (RSA) of implants.

There is a need for standardization of radiostereometric (RSA) investigations to facilitate comparison of outcome reported from different research groups. In this document, 6 research centers have agreed upon standards for terminology, description and use of RSA arrangement including radiographic set-up and techniques. Consensus regarding minimum requirements for marker stability and scatter, choice of coordinate systems, and preferred way of describing prosthetic micromotion is of special interest. Some notes on data interpretation are also presented. Validation of RSA should be standardized by preparation of protocols for assessment of accuracy and precision. Practical issues related to loading of the joint by weight bearing or other conditions, follow-up intervals, length of follow-up, radiation dose, and the exclusion of patients due to technical errors are considered. Finally, we present a checklist of standardized output that should be included in any clinical RSA paper.This document will form the basis of a detailed standardization protocol under supervision of ISO and the European Standards Working Group on Joint Replacement Implants (CEN/TC 285/WG4). This protocol will facilitate inclusion of RSA in a standard protocol for implant testing before it is released for general use. Such a protocol-also including other recognized clinical outcome parameters-will reduce the risk of implanting potentially inferior prostheses on a large scale.

Accuracy of radiographic and radiostereometric wear measurement of different hip prostheses: an experimental study.

BACKGROUND: In vivo measurement of wear in the ball and socket articulation of total hip arthroplasties is of interest in the evaluation of both existing and new implants. Controversy reigns regarding the accuracy of different radiological measurement techniques and in particular how accuracy has been assessed. MATERIAL AND METHODS: We assessed the accuracy of 2 radiostereometric (RSA) techniques for wear measurement and 3 standard radiographic techniques, namely Imagika (image analyzing software), Imagika corrected for head center displacement, and the Charnley Duo method. 5 custom-made adjustable phantoms with different prosthetic components were used. RESULTS: In 20 measurements of all 5 phantoms at 3 levels of simulated wear (0.2 mm, 1.0 mm and 1.5 mm), the mean measurement error of the digital RSA examinations was 0.010 mm (accuracy 0.42). The corresponding error values for the three radiographic techniques were 0.19 (accuracy 1.3) for Charnley Duo, 0.13 (accuracy 1.3) for Imagika corrected, and 1.021 (accuracy 2.99) for Imagika. Measurement error decreased from 0.011 mm with ordinary RSA to 0.004 with RSA digital measurement. Head size, direction of wear in relation to the cup or type of prosthetic component did not influence the measurement error. The results of Charnley Duo and Imagika corrected were similar but the latter had an inexplicable systematic error in measuring one of the phantoms. Imagika had the worst results due to its inability to compensate for the out-of-head center effect. Alumina heads were difficult to analyze with all methods. INTERPRETATION: By using the ISO standard for assessing accuracy, RSA can be expected to measure wear with an accuracy of about 0.4 mm irrespective of prosthetic component studied or direction of wear, whereas the best technique, in our study, based on standard radiographs can be accurate to about 1.3 mm.

Experimental assessment of precision and accuracy of radiostereometric analysis for the determination of polyethylene wear in a total hip replacement model.

The purpose of this study was to develop and test a phantom model based on actual total hip replacement (THR) components to simulate the true penetration of the femoral head resulting from polyethylene wear. This model was used to study both the accuracy and the precision of radiostereometric analysis, RSA, in measuring wear. We also used this model to evaluate optimum tantalum bead configuration for this particular cup design when used in a clinical setting. A physical model of a total hip replacement (a phantom) was constructed which could simulate progressive, three-dimensional (3-D) penetration of the femoral head into the polyethylene component of a THR. Using a coordinate measuring machine (CMM) the positioning of the femoral head using the phantom was measured to be accurate to within 7 microm. The accuracy and precision of an RSA analysis system was determined from five repeat examinations of the phantom using various experimental set-ups of the phantom. The accuracy of the radiostereometric analysis, in this optimal experimental set-up studied was 33 microm for the medial direction, 22 microm for the superior direction, 86 microm for the posterior direction and 55 microm for the resultant 3-D vector length. The corresponding precision at the 95% confidence interval of the test results for repositioning the phantom five times, measured 8.4 microm for the medial direction, 5.5 microm for the superior direction, 16.0 microm for the posterior direction, and 13.5 microm for the resultant 3-D vector length. This in vitro model is proposed as a useful tool for developing a standard for the evaluation of radiostereometric and other radiographic methods used to measure in vivo wear.

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.