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Biomedical subjects

E R Valstar

Publications and source records attributed to E R Valstar.

12 recordsLinked to original sources

Failure of the uncoated titanium ProxiLock femoral hip prosthesis.

UNLABELLED: New prostheses should be evaluated for stability and clinical performance. In a prospective randomized clinical trial, we implanted 22 titanium (Ti) and 20 hydroxyapatite-coated (HA) ProxiLock femoral hip prostheses during total hip arthroplasty in 42 patients. The patients were followed for 24 months with clinical, radiographic and radiostereometric analysis. Full weightbearing was allowed immediately postoperatively. One patient with a titanium stem was lost to followup. During the first two months, 34 of the 41 stems subsided and/or rotated towards retroversion, regardless of stem type. At the 24-month followup 35 of the 41 prostheses were either fully stabilized (16 HA and 11 Ti stems) or had clinical irrelevant migration (four HA and four Ti stems). Six Ti prostheses showed continuous migrations with maximums of 4.7 mm translation and 12.2 degrees retroversion; four of these were revised, the other two had no clinical complaints. CLINICAL RELEVANCE: The migration pattern we found indicates insufficient primary fixation of the ProxiLock stem in an immediate full weightbearing protocol. The HA coating improves the secondary stability of the prosthesis compared to the uncoated stem. Early migration is associated with an increased risk of possible future loosening and revision, and therefore we discontinued the use of this prosthesis. LEVEL OF EVIDENCE: Therapeutic Level I. See Guidelines for Authors for a complete description of levels of evidence.

Adult↗

Does bioresorbable cage material influence segment stability in spinal interbody fusion?

To reduce long term complications associated with nonresorbable interbody fusion cages, bioresorbable cages are being developed. We investigated the influence of bioresorbable cage material on segment stability, intervertebral disc height and fusion in vivo using radiostereometric analysis comparing 70/30 poly(L-lactide-co-D,L-lactide) (PLDLLA) cages with titanium cages. Twenty-eight goats were randomized to receive PLDLLA (n = 21) or a titanium control (n = 7) cage at L3-L4. Range of motion for flexion and extension and change in intervertebral disc height were measured before and after surgery and at followup (3, 6, and 12 months). Fusion was graded with a validated radiographic score. Although the PLDLLA cage could not provide the optimal environment for a successful high fusion rate, the range of motion of the PLDLLA segments gradually decreased in time and was similar to the titanium control group at 12 months. In addition the decrease of intervertebral disc height was similar for both PLDLLA (1.4 +/- 0.8 mm) and titanium (1.3 +/- 1.0 mm) specimens. Both results showed a bioresorbable cage does not lead to less decrease of motion or more loss of intervertebral disc height in time compared to titanium. This study therefore supports further development of a bioresorbable cage concept.

Absorbable Implants↗

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.

Biomechanical Phenomena↗

Evaluation of three pose estimation algorithms for model-based roentgen stereophotogrammetric analysis.

Model-based roentgen stereophotogrammetric analysis (RSA) uses a three-dimensional surface model of an implant in order to estimate accurately the pose of that implant from a stereo pair of roentgen images. The technique is based on minimization of the difference between the actually projected contour of an implant and the virtually projected contour of a model of that same implant. The advantage of model-based RSA over conventional marker-based RSA is that it is not necessary to attach markers to the implant. In this paper, three pose estimation algorithms for model-based RSA are evaluated. The algorithms were assessed on the basis of their sensitivities to noise in the actual contour, to the amount of drop-outs in the actual contour, to the number of points in the actual contour and to shrinkage or expansion of the actual contour. The algorithms that were studied are the iterative inverse perspective matching (IIPM) algorithm, an algorithm based on minimization of the difference (DIF) between the actual contour and the virtual contour, and an algorithm based on minimization of the non-overlapping area (NOA) between the actual and virtual contour. The results of the simulation and phantom experiments show that the NOA algorithm does not fulfil the high accuracy that is necessary for model-based RSA. The IIPM and DIF algorithms are robust to the different distortions, making model-based RSA a possible replacement for marker-based RSA.

Algorithms↗

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.

Algorithms↗

Patterns of loosening of the glenoid component.

The incidence of loosening of a cemented glenoid component in total shoulder arthroplasty, detected by means of radiolucent lines or positional shift of the component on true anteroposterior radiographs, has been reported to be between 0% and 44%. Radiolucent lines are, however, difficult to detect and to interpret because of the mobility of the shoulder girdle and the obliquity of the glenoid which hinder standardisation of radiographs. We examined radiolucencies around cemented glenoid components in 48 patients, with a mean follow-up of 5.3 years, and found progressive changes to be present predominantly at the inferior pole of the component. This may hold a clue for the mechanism of loosening of this implant. In five patients we performed an additional analysis of loosening of the glenoid component using digital roentgen stereophotogrammetric analysis (RSA). After three years, three of the five implants had loosened (migration 1.2 to 5.5 mm). In only one, with gross loosening, were the radiological signs consistent with the RSA findings. When traditional radiographs are used for assessment, the rate of early loosening is underestimated. We recommend that RSA be used for this.

Aged↗

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.

Biomechanical Phenomena↗

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 0.013mm for translations and 0.033 degrees 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.

Arthroplasty, Replacement, Hip↗

Fast and accurate automated measurements in digitized stereophotogrammetric radiographs.

Until recently, Roentgen Stereophotogrammetric Analysis (RSA) required the manual definition of all markers using a high-resolution measurement table. To automate this tedious and time-consuming process and to eliminate observer variabilities, an analytical software package has been developed and validated for the detection, identification, and matching of markers in RSA radiographs. The digital analysis procedure consisted of the following steps: (1) the detection of markers using a variant of the Hough circle-finder technique; (2) the identification and labeling of the detected markers; (3) the reconstruction of the three-dimensional position of the bone markers and the prosthetic markers; and (4) the computation of micromotion. To assess the influence of film digitization, the measurements obtained from nine phantom radiographs using two different film scanners were compared with the results obtained by manual processing. All markers in the phantom radiographs were automatically detected and correctly labeled. The best results were obtained with a Vidar VXR-12 CCD scanner, for which the measurement errors were comparable to the errors associated with the manual approach. To assess the in vivo reproducibility, 30 patient radiographs were analyzed twice with the manual as well as with the automated procedure. Approximately, 85% of all calibration markers and bone markers were automatically detected and correctly matched. The calibration errors and the rigid-body errors show that the accuracy of the automated procedure is comparable to the accuracy of the manual procedure. The rigid-body errors had comparable mean values for both techniques: 0.05 mm for the tibia and 0.06 mm for the prosthesis. The reproducibility of the automated procedure showed to be slightly better than that of the manual procedure. The maximum errors in the computed translation and rotation of the tibial component were 0.11 mm and 0.24, compared to 0.13 mm and 0.27 for the manual RSA procedure. The total processing time is less than 10 min per radiograph, including interactive corrections, compared to approximately 1 h for the manual approach. In conclusion, a new and widely applicable, computer-assisted technique has become available to detect, identify, and match markers in RSA radiographs and to assess the micromotion of endoprostheses. This new technique will be used in our clinic for our hip, knee, and elbow studies.

Automation↗

The effect of hydroxyapatite on the micromotion of total knee prostheses. A prospective, randomized, double-blind study.

A prospective, randomized, double-blind study was performed to evaluate three different means of fixing tibial components during total knee arthroplasty. Eleven components fixed with cement, ten hydroxyapatite-coated components fixed without cement, and ten noncoated components fixed without cement were studied. A posterior cruciate ligament-retaining total condylar implant was used. Micromotion of the components was assessed with roentgen stereophotogrammetric analysis during the two-year follow-up period. There were no significant differences among the patients with regard to age (mean [and standard deviation], 68 +/- 11.6 years), body-mass index (mean, 23 +/- 2.8 kilograms per square meter), or stage of osteoarthrosis (mean, 4 +/- 2.4 according to the classification system of Ahlback and 5 +/- 0.6 according to that of Larsen et al.). The diagnosis was osteoarthrosis in five knees, and it was rheumatoid arthritis in twenty-six. The clinical scores were similar among the study groups. According to the system of the Knee Society, the mean preoperative functional score was 10 +/- 2.9 points and the mean preoperative knee score was 24 +/- 3.2 points. At the two-year follow-up evaluation, these scores were 41 +/- 8.3 and 79 +/- 3.2 points, respectively. A significant difference with regard to micromotion was found between the noncoated components fixed without cement and the hydroxyapatite-coated components fixed without cement as well as between the noncoated components fixed without cement and the components fixed with cement (p < 0.001, analysis of variance). The hydroxyapatite-coated components fixed without cement and the components fixed with cement both had far less micromotion along the longitudinal axis (subsidence) throughout the follow-up period than did the noncoated components fixed without cement. At the two-year follow-up evaluation, the subsidence of the noncoated components was -0.73 +/- 0.924 millimeter, the subsidence of the cemented components was -0.05 +/- 0.109 millimeter, and the subsidence of the hydroxyapatite-coated components was -0.06 +/- 0.169 millimeter. The cemented components as well as the hydroxyapatite-coated components also had less translation along the transverse axis (p < 0.001, analysis of variance) and the sagittal axis (p < 0.001, analysis of variance) compared with the noncoated components. In conclusion, micromotion of hydroxyapatite-coated tibial components fixed without cement was similar to that of tibial components fixed with cement. Therefore, hydroxyapatite, a biological mediator, may be necessary for the adequate fixation of tibial components when cement is not used.

Aged↗

Roentgen stereophotogrammetric analysis of metal-backed hemispherical cups without attached markers.

A method for the detection of micromotion of a metal-backed hemispherical acetabular cup is presented and tested. Unlike in conventional roentgen stereophotogrammetric analysis, the cup does not have to be marked with tantalum markers; the micromotion is calculated from the contours of the hemispherical part and the base circle of the cup. In this way, two rotations (tilt and anteversion) and the translations along the three cardinal axes are obtained. In a phantom study, the maximum error in the position of the cup's centre was 0.04 mm. The mean error in the orientation of the cup was 0.41 degree, with a 95% confidence interval of 0.28-0.54 degree. The in vivo accuracy was tested by repeated measurement of 21 radiographs from seven patients. The upper bound of the 95% tolerance interval for the translations along the transversal, longitudinal, and sagittal axes was 0.09, 0.07, and 0.34 mm, respectively: for the rotation, this upper bound was 0.39 degree. These results show that the new method, in which the position and orientation of metal-backed hemispherical cup is calculated from its projected contours, is a simple and accurate alternative to attaching markers to the cup.

Acetabulum↗