28. Clinical Surveillance of UHMWPE Using Radiographic Methods.pdf

7/27/2019 28. Clinical Surveillance of UHMWPE Using Radiographic Methods.pdf

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UHMWPE Biomaterials Handbook

Copyright 2009, Academic Press. Inc. All rights of reproduction in any form reserved.2009

Clinical Surveillance of UHMWPE UsingRadiographic Methods

Charles R. Bragdon, PhD

28.1 INTRODUCTION

As recounted in Chapter 4, ultra-high molecular weightpolyethylene (UHMWPE) has been the primary bearingmaterial used in total hip arthroplasty since its introductionby Charnley in 1962 [1]. UHMWPE is used to create theacetabular component of the reconstruction and in mostcases is coupled with a femoral head made of a cobaltchromium alloy, though other materials such as ceramicfemoral heads have also been used [25]. The originalUHMWPE acetabular components were cemented intothe acetabular bed of the pelvis. This design is still in usetoday along with a modular design consisting of a metalshell, which can be fixed to the skeleton with either bonecement or by biological fixation [68].

Wear of the articular surfaces has been a concernthroughout the inception of joint arthroplasty. The earlywork by Charnley [9] using PTFE as the bearing surface inthe acetabular component was a failure due to the extremelyhigh rate of wear of this material in vivo (Chapter 4). It isnow understood that periprosthetic osteolysis was associ-ated with this high wear material but was not recognized orinvestigated at that time. However, periprosthetic osteolysiscontinued to occur after the bearing surface was changedto UHMWPE but was believed to be either associated withsepsis or changes in the mechanical environment [9, 10].It is now well established that periprosthetic osteolysis issecondary to particulate debris liberated from the implants[1118]. At first, it was assumed that this process was

solely related to the acrylic cement used for implant fixa-tion, so called cement disease. However, later investiga-tions indicated that the process could occur in the absenceof polymethylmethacrylate and that a number of differenttypes of particles, if of the appropriate size and number,could elicit an osteolytic reaction [1931]. Though particle-induced osteolysis can be caused by many different parti-cles associated with the total hip reconstruction (variousmetals, bone cement, UHMWPE, and ceramics), due to itsprevalence, UHMWPE wear debris is the primary cause ofparticle-induced periprosthetic osteolysis around the con-temporary THR [3237]. Periprosthetic osteolysis does notoccur in all THR patients, and the response of individualpatients having comparable amounts of UHMWPE wearcan be quite variable. Current investigations are underwayto better understand this variable response. When it doesoccur, periprosthetic osteolysis can result in a dramatic lossof bone, failure of implant fixation, and the eventual needfor revision surgery (Figure 28.1).

Taking advantage of improvements in computer technol-ogy, a number of computer-assisted techniques have beendeveloped for making radiographic measurements [4653].While these techniques use a variety of image analysis andcomputational techniques, they are all designed to morequickly and reliably measure the changes in femoral headpenetration into the acetabular component from clinicalradiographs. Few, and to some extent, inconsistent resultsexist in the literature concerning accuracy and preci-sion of the various contemporary methods of performing

28.1 Introduction28.2 Early Manual Methods

for Radiographic

measurement

28.3 Radiostereometric Analysis28.4 Non-RSA Methods

28.4.1 Hip Analysis Suite

28.4.2 PolyWare

28.5 Other Factors to ConsiderReferences

Chapter 28

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UHMWPE Biomaterials Handbook424

radiographic measurements of femoral head displacement[46, 5458]. One reason for this is the continuing develop-ment of the methods associated with the introduction ofnew and improved calibration instruments, new mathemati-

cal algorithms, and the recent introduction of digital radio-graphic images [59].

Bragdon et al. developed a hip phantom capable ofsimulating the magnitude and direction of femoral headpenetration over time [60]. This physical model was usefulin evaluating various parameters that affect wear measure-

ments as well as in comparing the accuracy and precisionof difference software packages [6062]. In addition toevaluating different methodologies, a phantom model isused for training and validating new users of a system. Asimilar phantom can be fabricated using readily availablematerials (Figure 28.2).

While there are many computer-assisted methods avail-able for measuring femoral head penetration from sequen-tial radiographs, these methods can be divided into twogeneral categories. Radiostereometric analysis (RSA) is aspecialized technique that requires a specific type of radio-graph with the use of additional methods to perform precise

measurements. All other measurement techniques currentlyemployed use standard radiograph projections of the hipand are extensions of the early manual techniques. Eachcategory of techniques has advantages and disadvantages,which will be discussed in this chapter.

28.2 EARLY MANUAL METHODS FORRADIOGRAPHIC MEASUREMENT

Since Charnleys early experience with using PTFE as abearing material, the importance of measuring wear in vivoover time has been recognized. In fact, Charnley placeda wire marker in his first UHMWPE components for thisexact purpose [38] (Chapter 5, Figure 5.4). The measure-ment of femoral head penetration into the polyethylene linerof total hip replacements over time from sequential radio-graphs has become a standard way of assessing wear of theUHMWPE liner over time. The earlier manual techniques[3943] relied on the visual determination of the border ofthe femoral head, the visual determination of the edge ofthe UHMWPE on the radiograph, and the manual meas-urement of the changes in the position of the center of thefemoral head in relation to the acetabular component usinga ruler, digital micrometer, or template overlays. Thoughthese techniques have been used successfully in studies oflong duration where there has been a relatively large dis-placement of the femoral head, these techniques can resultin a high variability among different users, and they lackthe precision to yield useful information in shorter in vivotime periods or in cases where relatively small amountsof femoral head displacement has occurred [44]. An over-view of the history of these manual techniques was recentlypresented by McCalden et al. [45].

28.3 RADIOSTEREOMETRIC ANALYSIS

Radiostereometric analysis (RSA), developed by Selviket al. [51], is considered to be the most accurate method

FIGURE 28.1 Periprosthetic osteolysis, caused by UHMWPE weardebris, can result in massive bone loss around the acetabular and femoralcomponents, necessitating difficult revision arthroplasty.

FIGURE 28.2 A hip phantom can be assembled using three stackedlinear micrometers (Edmund Optics, Barrington, New Jersey, USA, PN:NT 37-982) and a Plexiglas frame. Pelvic and femoral sawbone mod-els (Pacific Research Laboratories, Vashon, Washington, USA) are used

to hold the total hip replacement components in an anatomical position.The ID of the socket has been enlarged to enable displacement of thefemoral head.


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Chapter | 28 Clinical Surveillance of UHMWPE Using Radiographic Methods 425

of determining the magnitude of relative displacementsfrom radiographic images for a variety of applications. Inits original form, this technique requires that a number ofsmall tantalum beads be placed in each region of interest

so that each component can be considered mathematicallyas a rigid body segment. Tantalum beads of 0.8 or 1.0 mmare commonly used due to their high radio density and bio-compatibility. A pair of stereo radiographs is taken with

the patient positioned in front of a calibration cage at thecenter of intersection of the two X-ray beams. This allowsfor the reconstruction of a three-dimensional coordinatesystem (Figure 28.3). Using automated image analysismethods, relative displacements of two rigid bodies canbe calculated from sequential pairs of stereo radiographs.Among the many applications of this technique, thismethod has been used to evaluate growth plate integrity,

joint kinematics, implant stability, spinal fusion integrity,and wear [6370].

To measure femoral head displacement into aUHMWPE acetabular component, the penetration of the

center of the femoral head into the UHMWPE is calcu-lated relative to a group of tantalum beads that have beeninserted into the acetabular component (Figure 28.4).

However, the requirement to have tantalum beads placedin vivo limits the use of this method to a relatively smallgroup of patients. Several commercially available softwarepackages have been developed to facilitate the RSA analy-sis. UmRSA [55], RSA-CMS [53], and the Oxford system[48] are the most developed. Though they are all based onthe same mathematical principles, they vary in the level of

FIGURE 28.3 The RSA calibration cage contains two groups of tanta-lum beads, which are used to create a three-dimensional coordinate system.The hip is placed at the intersection of the two X-ray beams. The three-dimensional location of the in vivo markers and the center of the femoralhead can then be calculated (Drawing courtesy of Dr. Johan Krrholm).

FIGURE 28.4 An example of a pair of stereo radiographs of a hip with the beads of the calibration cage and the UHMWPE marked in green (UmRSAv 6.0, RSA Biomedical, Sweden). The displacement of the center of the femoral head over time is measured against the group of tantalum markers placedin the acetabular component at the time of surgery.


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automation, algorithms used for automatic edge detection,and the resolution of the images that can be analyzed.

RSA methods are being developed to eliminatethe need for tantalum markers in the UHMWPE eitherby using CAD/CAM models of the implants provided by

the manufacturer or by using edge detection of the outercurvature of the acetabular component [71, 72]. Bragdonet al., using the UmRSA software, have shown in a com-parative analysis using the same clinical films that similarresults were obtained by either using the tantalum markersin the UHMWPE or by just using the edge detection of theacetabular component. However, the variance of the datawas the lowest when the information of the bead positionand the edge detection was combined [73].

The precision of the RSA method is dependant on thenumber of tantalum beads, the degree to which they aredistributed three dimensionally, as well as their relative

distance to the other object or segment. While in theoryeach patient would have a unique measurement precision,in reality good precision can be achieved by maximizingthe number of beads (a minimum of three) and by havingthem sufficiently disbursed so they do not fall in a singleline or plane. The precision of an RSA study can be deter-mined by the use of a double examination where two pairsof films are acquired on the same day [74]. The measuredmotion between these double examinations representsthe error. A standard deviation of the error of the doubleexaminations for all patients in a study can then be used tocalculate a 95% or 99% confidence interval, which repre-

sents the precision of the study group.For RSA studies, femoral head penetration data is usu-ally presented in a line graph format plotting penetration

versus time (Figure 28.5). Due to the relatively smallnumber of patients enrolled in an RSA study, the medianfemoral head penetration and standard error are commonlyreported, and appropriate statistical methods of compari-son, such as the Mann-Whitney test, are used.

28.4 NON-RSA METHODS

The two most commonly used non-RSA methods for deter-mining femoral head penetration from clinical radiographsare the Hip Analysis Suite and PolyWare software pack-ages, due to the fact that they have the most well-developedprograms and documentation. While other software pro-grams have been developed for this purpose, a descriptionof the approach taken by these two techniques provides anoverview of these non-RSA techniques. Neither the HipAnalysis Suite nor PolyWare require either in vivo mark-ers or a calibration cage because they use conventional A/Pand lateral projections of the hip, and therefore they can beapplied to a larger group of THR patients.

28.4.1 Hip Analysis Suite

The Hip Analysis Suite is a software package developedby Martell and introduced in 1997 [49] (Figure 28.6). Thismethod is commonly referred to as the Martell method.Precision of this technique under ideal experimental con-ditions has been shown to be 25 microns with a 95%

confidence interval [62]. While not as accurate as the RSAmethods, the long-term femoral head penetration meas-urements using this technique in a series of THR patients

Shell Marker method

Median linear wear and standard error of femoral heads

0.3

0.25

0.2

0.15

Medianpenetration(mm)

0.05

0

0.05

6 Months 1 Year 2 Year 3 Year

0.1

28 mm

36 mm

FIGURE 28.5 Graph of the median superior displacement of the femoral head relative to the acetabular bead segment over time for patients havingprimary THR using highly crosslinked UHMWPE and either 28 or 36 mm diameter femoral heads. The early penetration up to the first year representspredominantly creep of the UHMWPE. Thereafter, there is no further statistically significant migration of the femoral head, indicating negligible wearof the bearing surface. (Reprinted from J Arthroplasty, 22:125-9, 2007 with permission from Elsevier [73].)


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having conventional UHMWPE components has shownsimilar trends in the pattern of femoral head penetration toan RSA analysis, though the actual magnitude of penetra-tion measured by the two methods was different [75]. HipAnalysis Suite can be used to analyze two-dimensional or

three-dimensional changes in the femoral head center rela-tive to the acetabular component using either A/P or A/Pand lateral radiographs. The sign convention used for thevector direction is based on the original manual method ofLivermore [41]. Because the femoral head penetration isreported as a vector having both magnitude and direction,negative values of femoral head penetration can result. Instudies of conventional UHMWPE, negative values mostcommonly occur when measuring short intervals of timewhen relatively little true penetration has occurred [76].When measuring the femoral head penetration of newwear-resistant, highly crosslinked UHMWPE components,

positive and negative values are common, even beyond5 years postoperatively [7678] (Figure 28.7). Early nega-tive femoral head penetration values can also occur due topostsurgical muscle laxity, which allows the femoral headto sit slightly out of the full depth of the acetabular recesswhen the patient is lying supine. Having the patient inter-nally rotate his or her legs while lying supine can minimizethis subluxation of the hip. In addition, it is advisable toeliminate early postoperative films from the analysis, usingfilms taken more than 6 weeks after surgery and with thetime interval between radiographs greater than 6 months.With measurement of highly crosslinked UHMWPE com-

ponents, the persistence of negative femoral head penetra-tion values represents the limitation of the measurementtechnique in discerning very small changes in the position

of the femoral head over time and indicates the persistenceof the low wear of the bearing material in vivo.

Reliable femoral head penetration measurements areextremely dependant on film quality. Underexposed andoverexposed radiographs should not be included in film

series because the edge detection algorithm will be unableto track the true edge of the components. While prospec-tive studies of femoral head penetration allow for attemptsto improve the consistency of radiographic quality, manystudies that used these techniques are retrospective studiesin which image analysis was not originally contemplated.However, in either case, it is likely that some radio-graphs will not be appropriate for analysis. As a generalrule, films where less than two-thirds of the outline ofthe femoral head can be seen by visual inspection shouldbe excluded. Similarly, radiographs having low contractbetween the bone and acetabular shell should be excluded.

The position of the patient in relation to the film platecan also create projection artifacts that can adversely affectthe femoral head penetration measurements. The idealposition of the patient on the radiograph results in thecenter of the femoral head lying in the middle third of theimage. When the patient is positioned high or low in rela-tion to the center of the X-ray source, elliptical distortionoccurs, which compromises the circle-fitting algorithms.While elliptical fitting can be performed, its use has notbeen shown to improve the quality of the data over circlefitting. For this reason, as a general rule, films where thecenter of the femoral head falls outside of the middle third

of the image should not be used.While cross-table lateral films are useful for clinicalevaluation, the quality of the images are often not ideal for

FIGURE 28.6 An example of the resulting display following the analysis of two radiographs using the Martell method indicates the magnitude anddirection of the resulting displacement vector. Postprocessing macros supplied by Dr. John Martell facilitate tabulation and graphing of a large numberof penetration measurements.


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visualizing the borders of the femoral head and acetabularshell. Martell et al. found that because the majority of thefemoral head penetration occurs superiorly and medially,

which is in the plane of the A/P projection, the 3-D deter-mination of femoral head penetration was comparable tothe 2-D penetration measurements with the associated dis-advantage of increased scatter of the data due to the use ofthe cross-table lateral projection [58].

As described by Bragdon et al. [76], there are severalways to display and analyze femoral head penetration datawhen a series of patients have multiple radiographs foranalysis over time. One way is to report the average of thetotal femoral head penetration by using the earliest post-operative and the latest follow-up film. While ignoring allchanges that occur in the intervening films, this method pro-

vides a snapshot of the femoral head penetration at a singletime, and comparisons can be made using a students t-test.Penetration values must be normalized by dividing eachvalue by the total time between films to arrive at an averagefemoral head penetration rate. While this is a valid approachfor reporting penetration data and is useful in patient serieswhere intervening radiographs are not available, it has sev-eral limitations. The results for each patient are depend-ant on one observation so that image quality is even moreimportant. Also, it does not allow monitoring of changesin the penetration rate over time. As shown in Figure 28.7,when multiple films for each patient are available for analy-

sis, multiple observations over time for each patient can bemade based on an appropriate early postoperative baselinefilm. Femoral head penetration rates for a population or for

an individual patient can be calculated by a linear regres-sion analysis of a scatter plot of the data. By taking multi-ple observations for each patient, the effect of the variability

of film quality is minimized. In addition, by using differentfilms within the series as the baseline film, changes in thewear behavior of the bearing surface over time, which maynot be otherwise appreciated, may be detected.

28.4.2 PolyWare

Similar in principle to the Hip Analysis System, thePolyWare software package was developed by PeterDevane and was presented in 1994 in the Frank StinchfieldAward Paper [46, 79]. This method is commonly referred

to as the Devane method. It was designed specifically formeasuring three-dimensional changes in the position ofthe center of the femoral head relative to the center of theacetabular component by using serial radiographs of boththe anterior/posterior (A/P) and lateral radiographic viewsof the reconstructed hip. Edge detection algorithms areused to to determine the centers of the femoral head andacetabular component. Correction for magnification ismade by using the known diameter of the femoral head.There are several versions of this software available withthe newer version, PolyWare Auto version 6.01, requiringonly the A/P radiograph and minimal user interaction. This

is made possible by incorporating known dimensions of theacetabular implants within a reference table of the software.This software reports the magnitude of vector wear but not

2.5

2

1.5

Linearwear(mm)

1

0.5

0

0.5 Conventional

Conventional

Cross-linked

Cross-linked

Years from surgery

Total penetration scatter plot (method B) for 28mm femoral head diameter groups

comparing conventional and cross-linked polyethylene

y0.0162x0.0773

R20.0078

y0.1355x0.1082

R20.3282

54321 6

1

0

FIGURE 28.7 A scatter plot of all femoral head penetration measurements made relative to the early postoperative radiograph for two groups ofpatients, one having a primary THR using conventional UHMWPE and the other using highly crosslinked UHMWPE. The linear regression line rep-resents the femoral head penetration rates. While both groups have data distributed evenly on either side of the regression line, negative values persistthroughout the follow-up period due to the fact that very little penetration occurs. There is no correlation between femoral head penetration and timeusing this form of highly crosslinked UHMWPE. (Reprinted from J Arthroplasty, 21:935-943, 2006 with permission from Elsevier [76] .)


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direction, essentially the absolute value of the vector dis-placement. Greene et al. [80] performed a comparativestudy between PolyWare Auto and Hip Analysis Suite soft-ware results using a group of clinical radiographs of THR

patients having highly crosslinked UHMWPE acetabularcomponents. While the formats of the output values aredissimilar, they were able to perform direct statistical com-parisons by comparing the absolute values of the Martellmethod to the output of the Devane method. In addition,they converted the output of the Devane method to a vec-tor output having magnitude and direction based on thesign convention used by Martell [49]. They report signifi-cant differences in the femoral head migration output val-ues. A similar study using the most recent versions of bothprograms compared the head penetration vector in termsof absolute value of the magnitude of the vector as well as

the magnitude with its directional component of sign value.This comparison showed no significant differences betweenthe wear and wear rates observed by the programs when thesign convention was included, but it showed a significantdifference when the absolute value was taken. These impor-tant differences in the data output of these two programs aswell as other programs must be considered when attempt-ing to compare femoral head penetration results fromdifferent studies.

28.5 OTHER FACTORS TO CONSIDER

Femoral head penetration into UHMWPE acetabular com-ponents is a result of both removal of UHMWPE from thebearing surface, true wear, and creep of the UHMWPE byplastic and elastic deformation. It is generally understoodthat creep occurs early as a result of loading of the artic-ulation and is not a concern after the first year of in vivouse [73, 76, 8188]. As seen in Figure 28.5, creep seems toaccount for roughly 0.1 mm of femoral head penetration inthe first year. In an attempt to eliminate the component ofcreep for femoral head displacement measurements, somestudies have ignored the early radiographs and started the

analysis using a film after the first postoperative year as thebaseline film [7678]. While in theory creep does not stop,the rate of femoral head penetration due to creep decreasessubstantially after the first year to a nearly undetectablelevel. It may be, however, that this continued creep couldaccumulate over time to an amount that is discernable inlong-term studies that have a sufficient number of follow-upradiographs. It may be that this accumulative effect of con-tinued creep may be more apparent in studies of new, lowwear UHMWPE. For this reason, the affect of continuedcreep on the results of long-term clinical studies of femoralhead displacement needs to be considered.

A key assumption of any femoral head penetration meas-urement is that the femoral head is seated into the deepestportion of the acetabular component at each radiographic

examination. However, subluxation of the hip does occurunder certain circumstances and is affected by the posi-tion of the leg and the degree of muscle tone. Several stud-ies have been conducted to determine if radiographs taken

while the patient is standing would significantly improvethe resulting data but have reached conflicting conclusions[8991]. Bragdon et al. performed a comparative study ona large group of patients who had both standing and supineradiographs taken on the same day as part of an RSA study.As part of the radiographic protocol, all patients were askedto slightly internally rotate their legs during the supineexamination. The use of this technique increases the muscleload across the hip and, in the majority of cases studied intheir paper, seemed to have helped minimize the differencebetween the results of using standing or supine radiographs.However, in a number of patients, the difference in the posi-

tion of the femoral head between a standing and a supineexamination that were taken on the same day was greaterthan could be explained by measurement error alone. It islikely that some of the patient-to-patient variability that isreported in such radiographic studies is due in part to thevariability in seating of the femoral head during the supineexamination. From the analysis of the 117 hips in theirpaper, the use of supine radiographs in an RSA evaluationof wear appeared to be a reasonable approach provided thatthe number of patients enrolled in the study is sufficient toaccommodate the added patient-to-patient variability andthat care is taken during the examination to ensure that this

source of variation was minimized.The techniques for measuring femoral head penetra-tion from radiographs described here are primarily used inevaluating femoral head penetration in total hip replace-ments that use UHMWPE as the acetabular bearing surfacearticulating against a hard cobalt chrome or ceramic femo-ral head. While wear is also a concern in other bearing cou-ples, such as metal on metal and ceramic on ceramic, thesealternative bearings are not ideal candidates for these wearmeasurement techniques. Not only does the radiodensity ofthese materials create difficulties in visualizing the bordersof the femoral heads, but substantial wear can occur without

significant displacement of the femoral head. While wearresulting in 0.2 to 2.0 mm of wear can often occur with con-ventional UHMWPE bearings with no significant impact onfunction, substantial wear of hard-on-hard bearings resultsin an early failure of the reconstruction, necessitating revi-sion surgery long before this wear can be visualized onplain radiographs. The utility of using these measurementtechniques on long-term studies of hard-on-hard bearingshas not yet been demonstrated.

The goal of using radiographic analysis techniquesto measure wear in total hip arthroplasty has changedover time. Originally, they were used to correlate the

amount of femoral head penetration with the incidenceof periprosthetic osteolysis. This association is now wellestablished and irrefutable. New bearing materials, such as


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hard-on-hard and highly crosslinked UHMWPEs, havebeen developed and are currently in use to minimizearticular wear. These radiographic analysis techniquesare now being used to monitor the in vivo wear perform-

ance of these new bearings, primarily highly crosslinkedUHMWPE, as a form of an early warning method to ensurethat the low wear performance demonstrated in in vitrotesting translates to the clinical setting and that these lowwear properties do not degrade over time. The year 2008will mark the first decade since the introduction of highlycrosslinked UHMWPE in total hip arthroplasty. Whilelong-term studies continue to monitor patients with theseexisting highly crosslinked UHMWPEs, new formulationscontinue to be developed and introduced to the market,making the continued use of these techniques an importantpart of clinical follow-up studies. However, the desired end

result of low-wear bearings is the demonstrable decrease, ifnot elimination, of periprosthetic osteolysis. Several recentstudies have reported on the use of CT scans as a meansfor early detection of osteolysis before it is manifested onplain radiographs [9298]. With the continued advancesin imaging technology and metal artifact suppression, it islikely that CT or another type of imaging technique will beadded as a tool for the clinical surveillance of UHMWPE.These techniques will be useful not only for evaluatingtotal hip replacements, but also other joints such as totalknee replacements where no reliable techniques for evalu-ating wear are currently available.

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