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Assessment of interchangeable applicability

of two wear detection methods for


total hip arthroplasty within
an experimental phantom-model setup
Lehrstuhl für Orthopädie mit Orthopädischer Chirurgie
Orthopädische Universitätsklinik Erlangen
im Malteser Waldkrankenhaus gGmbH Erlangen
Direktor: Univ. Prof. Dr. med. Raimund Forst

Der Medizinischen Fakultät


der Friedrich-Alexander-Universität
Erlangen-Nürnberg
zur

Erlangung des Doktorgrades Dr. med


vorgelegt von

Junzhe Wu
Als Dissertation genehmigt von der
Medizinischen Fakultät der Friedrich-Alexander-Universität
Erlangen-Nürnberg

Vorsitzender des Promotionsorgans: Prof. Dr. Markus F. Neurath

Gutachter: Prof. Dr. Raimund Forst

Gutachter: Prof. Dr. Torsten Kuwert

Tag der mündlichen Prüfung: 01.Juni 2021

i
Table of contents

Abstract .................................................................................................................... 4
Zusammenfassung ................................................................................................... 7
1 Introduction ...................................................................................................... 10
1.1 Importance of wear measurement of THA .................................................10
1.1.1 Indications of THA ..............................................................................10
1.1.2 Staging and treatment of hip osteoarthritis..........................................11
1.1.3 Prosthetic interface commonly used in total hip arthroplasty ...............12
1.1.4 Importance of different types of polyethylene......................................12
1.1.5 Common reasons for the failure of THA ..............................................13
1.1.6 Definition and features of wear ...........................................................13
1.1.7 Applications of wear measurement .....................................................14
1.2 Wear measurement techniques .................................................................14
1.2.1 Classification of wear measurement techniques .................................15
1.2.2 Common wear measurement techniques ...........................................15
1.2.3 Comparison between two dimensional (2D) techniques and three
dimensional (3D) techniques ...........................................................................18
1.2.4 Specific principles of wear measurement techniques in this experiment
18
1.3 Gaps in clinical routine ..............................................................................20
1.3.1 Applications of preoperative planning software programs ...................20
1.3.2 Causes of wear measurement using plain pelvic radiographs.............22
1.3.3 Influencing factors of artificial joint wear .............................................23
1.3.4 Correlation of pelvic positions and wear measurement .......................25
1.4 Aim, hypotheses, and innovation of this study ...........................................26
2 Material and Methods ...................................................................................... 27
2.1 Measurement setup...................................................................................28
2.2 Phantom model .........................................................................................30
2.3 Measurement protocol...............................................................................33
2.4 Data analysis.............................................................................................36
2.5 Statistics....................................................................................................37
3 Results ............................................................................................................ 38
3.1 3Dwear measurement result ........................................................................38
3.2 2Dwear measurement result ........................................................................42

ii
3.3 Comparison between 3Dwear and 2Dwear measurement results ...................44
3.3.1 Comparison between 3Dwear and 2Dwear measurement results in the
pelvic neutral position ......................................................................................44
3.3.2 Comparison between 3Dwear and 2Dwear measurement results in all
pelvic positions as a whole ..............................................................................45
3.3.3 Comparison between 3Dwear and 2Dwear measurement results in all
pelvic positions individually ..............................................................................48
4 Discussion ....................................................................................................... 50
4.1 Restating the findings of the main results ..................................................50
4.2 Comparison to other studies of wear measurement...................................50
4.2.1 Comparison to other individual 2D techniques by computer-assisted
software programs ...........................................................................................51
4.2.2 Comparison to other individual 3D techniques by RSA .......................51
4.2.3 Comparison to other combined 2D and 3D techniques .......................52
4.2.4 Comparison to other studies involving pelvic orientations ...................53
4.3 Strengths of the experiment ......................................................................54
4.3.1 2Dwear measurement systems can meet clinical requirements.............54
4.3.2 Evaluating accurate wear measurement ranges by setting different
wear groups .....................................................................................................55
4.3.3 Simulating the problem of pelvic misalignment during clinical filming by
setting different pelvic orientations ...................................................................55
4.4 Limitations of the experiment .....................................................................56
4.4.1 Factors affecting the precision and accuracy of wear measurement ...57
4.4.2 Limitations ..........................................................................................57
4.5 Future work ...............................................................................................58
4.6 Conclusion ................................................................................................59
5 Reference list................................................................................................... 60
6 List of abbreviations ......................................................................................... 67
7 List of publications ........................................................................................... 69
8 Appendix ......................................................................................................... 70
9 Acknowledgements.......................................................................................... 71

iii
Abstract

Abstract
Introduction / Background
Osteoarthritis (OA) constitutes the most common reason for total hip arthro-
plasty (THA).

The obligatory preoperative planning is laid down in the statutes of certified


German endoprosthetic centers. Next to planning the implant size and position,
additional applications are included within such planning software solutions.
One of these applications presents the detection of in vivo wear. Wear of pol-
yethylene (PE) components is a major factor limiting the longevity of THA.

Currently, common techniques for measuring wear include 2D analysis based


on conventional a.p. radiographs (2Dwear) and 3D analysis using exclusive ra-
diological technologies (3Dwear), such as Roentgen Stereophotogrammetric
Analysis (RSA). The application of relevant techniques to measure wear in vivo
can help better understand the bearing behaviors of total joint arthroplasty by
evaluating wear rates of different materials. Meanwhile, surgeons can advise
patients when revision surgery is necessary based on the level of wear.

RSA is widely regarded as a gold standard for wear measurement. However,


RSA requires additional equipment and specific settings (extra x-ray equip-
ment, calibration boxes, etc.), which obstructs its routine clinical application.

However, the change of patient positions, for example, tilt or rotation of the
pelvis, may influence the accuracy of wear measurement in THA.

This study aims to investigate whether a 2Dwear detection method can be an


alternative to 3Dwear and how these two wear detection methods are impacted
by the positions of the pelvis. It is hypothesized that the accuracy and precision
of the 3Dwear approach are superior to conventional PE wear detection of THA,
using single plain radiographs. Furthermore, the effect of various pelvic posi-
tions on the PE wear measurements for both methods is investigated using an
experimental phantom model.

Material and Methods

4
Abstract

A phantom model was designed to simulate a defined linear PE wear of an


acetabular insert. It consisted out of a micrometer screw and a femoral bone-
implant-model (FBIM), which could be moved precisely around three degrees
of freedom (DOF) relative to an acetabular bone-implant-model (ABIM). Rela-
tive to the standard “neutral” position, the ABIM could be positioned in three
DOF (tilt, obliquity, and rotation). This phantom was located within a radiologic
measurement setup, which was able to capture RSA and conventional x-ray
images in parallel without moving the phantom model. Three different wear
protocols were performed by FBIM for seven different orientations of the ABIM.
Each protocol was repeated five times per ABIM orientation. The two methods
of 2Dwear and 3Dwear were used to obtain corresponding images and compared
in many aspects from seven different pelvic orientations. Precision, accuracy,
and pelvic position factors for wear measurements were evaluated.

Results
From the perspective between different wear detection methods, the precision
and accuracy were 0.206 mm and 0.159 mm for 2Dwear and 0.043 mm and
0.017 mm for 3Dwear, respectively. With respect to different pelvic positions, for
2Dwear, p values of the four relative positions were all less than 0.05; for 3Dwear,
the p-value between pelvic lateral tilted left (obliquity left) 5-degree position
and the pelvic neutral position was less than 0.05. From the perspective be-
tween different wear groups, for 2Dwear, the medium wear group was not sig-
nificantly different among all wear positions (p = 0.068); for 3Dwear, the low wear
group was not significantly different among all wear positions (p = 0.235).

Discussion / Conclusion
For the two methods used in this experiment, i.e. 3Dwear and 2Dwear, precision
and accuracy using 3Dwear were approximately by factor 5 and 9 better than
for the 2Dwear approach despite the pelvic positions. The low wear group in
3Dwear and the medium wear group in 2Dwear were relatively unaffected by pel-
vic positions. Attention should be paid to the potential malposition of the pelvis
during the image acquisition because this affected the 2Dwear measurement
outcome significantly. If this is taken into account, an in vivo wear measure-
ment will be possible using the 2Dwear technology because 2Dwear is an excel-
lent alternative to 3Dwear.

5
Abstract

Partial of the present dissertation will be turned into an article for the
future publication to scientific peer review journal.

6
Zusammenfassung

Zusammenfassung
Einleitung / Hintergrund
Die Osteoarthrose (OA) ist der häufigste Grund für eine Hüfttotalendoprothese
(THA).

Die obligate präoperative Planung ist in den Statuten der zertifizierten


deutschen Endoprothetikzentren festgelegt. Neben der präoperativen Planung
der Implantatgröße und -position sind weitere Anwendungen in solchen
Planungssoftwarelösungen enthalten. In einer der kommerziell erhältlichen
Anwendungen ist z.B. die Option verfügbar, den Verschleiß der Artikulation in-
vivo zu bestimmen. Der Verschleiß von Polyethylen (PE)-Komponenten ist ein
wesentlicher Faktor, der die Langlebigkeit der THA limitiert.

Zu den derzeit üblichen Techniken zur Verschleißmessung gehören die 2D-


Analyse auf der Grundlage konventioneller a.p.-Röntgenaufnahmen (2Dwear)
und die 3D-Analyse unter Verwendung spezieller radiologischer Technologien
(3Dwear), wie z.B. der Roentgen Stereophotogrammetric Analysis (RSA). Die
Anwendung besonderer Techniken zur in-vivo-Verschleißmessung kann dazu
beitragen, das Implantatverhalten im Verlauf besser zu verstehen, indem die
Verschleißraten verschiedener Materialien bewertet werden. Zudem können
Operateure ihre Patienten rechtzeitig beraten, wenn ein Revisionseingriff
aufgrund fortgeschrittenen Abriebs ratsam ist.

Die RSA wird gegenwärtig als Goldstandard für Verschleißmessungen


angesehen. Sie erfordert jedoch eine zusätzliche technische Ausrüstung /
Messtechnik (2 Röntgenröhren, Kalibrierbox, etc.), was ihre routinemäßige
klinische Anwendung einschränkt.

Die Veränderung der Patientenposition, z.B. Neigung oder Rotation des


Beckens, kann die Genauigkeit der Verschleißmessung in der
Hüftendoprothetik beeinflussen.

In dieser Studie soll untersucht werden, ob eine 2D wear-Methode eine


Alternative zu einer 3Dwear-Methode sein kann und wie diese beiden
Verschleißerkennungsmethoden durch die Position des Beckens beeinflusst
werden. Es wird die Hypothese aufgestellt, dass die Genauigkeit und Präzision
des 3Dwear-Ansatzes der konventionellen PE-Verschleißerkennung von THA
7
Zusammenfassung

unter Verwendung einzelner, einfacher Röntgenaufnahmen überlegen sind.


Darüber hinaus wird der Einfluss verschiedener Beckenpositionen auf die PE-
Verschleißmessungen für beide Methoden mit einem experimentellen
Phantommodell untersucht.

Material und Methoden


Es wurde ein spezielles Phantommodell entwickelt, um einen definierten
linearen PE-Verschleiß eines Hüftgelenkpfanneninlays zu simulieren. Es
bestand aus einer Mikrometerschraube und einem femoralen Knochen-
Implantat-Modell (FBIM), das relativ zu einem acetabularen Knochen-
Implantat-Modell (ABIM) präzise um drei Freiheitsgrade (DOF) bewegt werden
konnte. Relativ zur Standard-"neutralen" Position konnte das ABIM in drei
Freiheitsgraden (Neigung, Schräglage und Rotation) positioniert werden. Das
Phantommodell befand sich innerhalb eines radiologischen Messaufbaus, der
in der Lage war, RSA- und konventionelle Röntgenbilder parallel aufzunehmen,
ohne das Phantommodell zu bewegen. Drei verschiedene
Verschleißprotokolle wurden vom FBIM für sieben verschiedene
Ausrichtungen des ABIM durchgeführt. Jedes Protokoll wurde pro ABIM-
Orientierung fünf Mal wiederholt. Die beiden Methoden von 2Dwear und 3Dwear
wurden verwendet, um entsprechende Bilder zu erhalten und in vielen
Aspekten aus sieben verschiedenen Beckenorientierungen verglichen.
Präzision, Genauigkeit und Beckenpositionsfaktoren wurden für die
Verschleißmessungen ausgewertet.

Ergebnisse
Bezogen auf die verschiedenen Verschleißerkennungsmethoden betrug die
Präzision und Genauigkeit 0,206 mm und 0,159 mm für 2Dwear bzw. 0,043 mm
und 0,017 mm für 3Dwear. Bezüglich der verschiedenen Beckenpositionen
waren bei 2Dwear die p-Werte der vier relativen Positionen alle kleiner als 0,05;
bei 3Dwear war der p-Wert zwischen der seitlich nach links geneigten
(Schräglage links) 5-Grad-Position des Beckens und der neutralen
Beckenposition kleiner als 0,05. Im Vergleich zwischen den verschiedenen
Verschleißgruppen unterschied sich bei 2Dwear die mittlere Verschleißgruppe
nicht signifikant zwischen allen Verschleißpositionen (p = 0,068); bei 3D wear
unterschied sich die niedrige Verschleißgruppe nicht signifikant zwischen allen
Verschleißpositionen (p = 0,235).

8
Zusammenfassung

Diskussion / Fazit
Für die beiden in diesem Experiment verwendeten Verschleißmessmethoden,
d.h. 3Dwear und 2Dwear, waren Präzision und Genauigkeit unter Verwendung
von 3Dwear trotz der unterschiedlichen Beckenpositionen um den Faktor 5 und
9 besser als bei der 2Dwear-Methode. Die ermittelten Abriebraten für die
Gruppe mit geringem Verschleiß in 3Dwear und die Gruppe mit mittlerem
Verschleiß in 2Dwear waren unbeeinflusst von den Beckenpositionen. Es sollte
allerdings bei der Bildaufnahme auf eine mögliche Fehllagerung des Beckens
geachtet werden, da diese das Messergebnis von 2Dwear erheblich beeinflusst
hat. Wenn dies berücksichtigt wird, ist eine in-vivo-Verschleißmessung mit der
Technologie von 2Dwear möglich, da 2Dwear eine ausgezeichnete Alternative zu
3Dwear ist.

Teile der vorliegenden Dissertation sind für die Veröffentlichung in Form


eines Artikels in einer wissenschaftlichen Fachzeitschrift vorgesehen.

9
Introduction

1 Introduction
In recent years, there has been an increasing number in total hip arthroplasty
(THA) because the technology of THA is becoming more mature and perfect,
which depends on the development of artificial joint prostheses. The lifespan
of artificial hip joints is still a major problem due to inevitable wear, so there are
several wear detection techniques. With the improvement of the wear proper-
ties of artificial joint materials, the wear rate is now decreasing, which places
higher demands on the accuracy of wear measurement methods. At present,
Roentgen Stereophotogrammetric Analysis (RSA) is a relatively accurate and
reliable method for in vivo wear measurement, presenting the current gold
standard (Uddin et al. 2016). However, the experimental equipment and soft-
ware available in the clinical practice are limited, and the radiographic imaging
process is generally affected by pelvic positions. Based on everyday clinical
practice, the experiment is designed to compare two software programs in
seven different pelvic positions.

1.1 Importance of wear measurement of THA


During the past decade, cross-linked polyethylene (XLPE) cups have been
used widely because of a much-reduced rate of wear (Eggli et al. 1998, Davila
et al. 2006, Stilling et al. 2009), which addresses higher demands on the ac-
curacy and precision of wear measurement techniques. At present, a primary
current research focus is on how to detect in vivo wear measurement involving
total hip arthroplasty and total knee arthroplasty (Van IJsseldijk et al. 2013, van
IJsseldijk et al. 2014, Van Ijsseldijk et al. 2016).

1.1.1 Indications of THA


According to the Robert Koch Institute (RKI), the lifetime prevalence of osteo-
arthritis in Germany in 2012 was high, with 27.8% in women and 19.7% in men,
respectively (Seidlitz and Kip 2018). Based on another study in recent years,
the prevalence of osteoarthritis in 2014 aged 60 years or older in Germany
was 23.9% in women and 18.3% in men (Postler et al. 2018). A survey indi-
cated that the prevalence of OA increased from 6.6% to 14.3% from 1999 to

10
Introduction

2014 in the United States (Park et al. 2018). Osteoarthritis, rheumatoid arthritis,
femoral head necrosis, developmental dysplasia of the hip, and femoral neck
fracture are the most common indications for THA. Over 80% of all primary hip
surgery is due to osteoarthritis (OA) of the hip (Seidlitz and Kip 2018), which
is the most significant reason for requiring hip joint replacement. Total hip ar-
throplasty (THA) is a crucial technique for OA, which is increasingly perfect
over the past twenty years, increasing the quality of life.

1.1.2 Staging and treatment of hip osteoarthritis


Osteoarthritis is the most common arthritis, which occurs in the knee, hip, and
hand joints, causing a high disability rate in the elderly (Kolasinski et al. 2020).
The cause of OA is a combination of internal and external factors, including
joint anatomy, body weight, injuries, diseases, and load (Mamisch et al. 2010).
Conventional x-rays are the most common way to assess osteoarthritis. Ac-
cording to the Kellgren-Lawrence grading system, osteoarthritis is divided into
five radiological levels (Grade 0: no manifestations of osteoarthritis, Grade 1:
suspicious joint space narrowing, Grade 2: definite osteophyte formation and
possible joint space narrowing, Grade 3: definite joint space narrowing, Grade
4: severe joint space narrowing) (Guermazi et al. 2009). Generally, joint space
narrowing is a critical indicator of the severity of osteoarthritis, but this gradu-
ation lacks an assessment of cartilage conditions. Currently, magnetic reso-
nance imaging (MRI) represents the best technique because articular cartilage,
synovium, and menisci can be well visualized by MRI (Guermazi et al. 2009,
Mamisch et al. 2010). Referring to the “2019 American College of Rheumatol-
ogy / Arthritis Foundation guideline”, the management of OA is comprehensive
(Kolasinski et al. 2020), which includes nonpharmacologic, pharmacologic and
surgical treatments (Lespasio et al. 2018). The nonpharmacologic treatments
involve exercise, physical therapy, weight loss, Tai chi, acupuncture, and so
forth. The pharmacologic therapies mainly include acetaminophen, nonsteroi-
dal anti-inflammatory drugs (NSAIDs) (oral and topical), glucosamine, and in-
tra-articular injections, such as hyaluronic acids, corticosteroids, platelet-rich
plasma (PRP), stem cell. For surgical treatments, arthroscopy is performed
during early OA stages; hip resurfacing is an alternative to THA for younger
patients, but it is controversial in terms of success rates (Seppänen et al. 2016,

11
Introduction

Scholes et al. 2019); THA is suitable for advanced osteoarthritis, especially


when hip pain cannot be alleviated.

1.1.3 Prosthetic interface commonly used in total hip arthroplasty


Currently, prosthetic interfaces generally used in total hip arthroplasty are
hard-to-soft and hard-to-hard. The hard-to-soft interface includes metal-on-
polyethylene (MoPE) and ceramic-on-polyethylene (CoPE), and the hard-to-
hard interface includes ceramic-on-ceramic (CoC), metal-on-metal (MoM) and
ceramic-on-metal (CoM). It is worth pointing out that, despite the theoretical
advantages (Affatato et al. 2010, Zhu et al. 2017) of CoM bearings, many of
the poor clinical follow-up results lead to lower use (Valentí et al. 2007,
Deshmukh et al. 2012, Hill et al. 2015, Zeng et al. 2015, Zhu et al. 2017, Hig-
gins et al. 2020).

MoPE interface was previously the most widely applied and most classic type
of total hip prosthesis. For example, a survey study showed that MoPE was
the most commonly reported bearing, with a proportion of 51% between 2005
and 2006 in the United States (Bozic et al. 2009). However, American Joint
Replacement Register (AJRR) reported that the most widely used bearing was
a CoPE combination with 67.3% in 2018 (Surgeons 2019). In 78.4% of all THA
treatments in Germany, a CoPE bearing was used (Grimberg et al. 2019). In
clinical practice, CoC is at risk of breakage (Jeffers and Walter 2012), and MoM
is concerned about the release of metal ions (Clarke et al. 2003). On the other
hand, consider that when a CoC or MoM bearing is used, the visibility of the
head contour in the cup with x-ray or stereo x-rays may be unsatisfactory.
Therefore, this experiment was conducted on MoPE, and then the wear meas-
urements were simulated to calculate the linear wear of polyethylene.

1.1.4 Importance of different types of polyethylene


There are currently three main types of PE: ultrahigh molecular weight poly-
ethylene (UHMWPE), highly cross-linked polyethylene (HXLPE), and antioxi-
dant PE (i.e. HXLPE + antioxidant: vitamin E). Due to having a lower rate of
wear, the percentage of antioxidant PE increased year by year, from 4% in

12
Introduction

2012 to 14% in 2018, which was the case in the US (Surgeons 2019). Similarly,
the antioxidant PE ratio in Germany was 17.7% based on the annual report
2019 of Endoprostheses Register Germany (Grimberg et al. 2019).

Clinically, a study presented that first-generation crosslinked polyethylene ob-


tained higher wear resistance after 13 years of implantation compared to con-
ventional polyethylene (Teeter et al. 2017). Vitamin E is a free radical scaven-
ger to improve oxidation resistance (Affatato et al. 2016). Vitamin E-blended,
cross-linked polyethylene (XLPE_VE) has been used in clinical practice in hips
since 2007 and in knees since 2008 (Oral and Muratoglu 2011). And XLPE_VE
has less wear rate than highly cross-linked liners without vitamin E (Shareghi
et al. 2017).

1.1.5 Common reasons for the failure of THA


The common modes of failure of THA consist of wear, aseptic loosening, dis-
location, infection, reaction to metal debris, periprosthetic fractures, and unex-
plained hip pain (Karachalios et al. 2018). Furthermore, a considerable amount
of literature has demonstrated that instability, infection, or aseptic loosening
are leading reasons for revision failure for THA. A large sample review (Ken-
ney et al. 2019) indicated that the proportion of failure reasons was aseptic
loosening (23.19%), instability (22.43%), and infection (22.13%). Currently,
there are many theories about aseptic implant loosening (Sundfeldt et al. 2006).
The theories include cement disease, PE-particle, micromotion, high fluid pres-
sure, and individual variations. And aseptic loosening associating with partic-
ulate wear debris is a significant area of interest within the field of current re-
search for the wear of polyethylene (PE) yielding particulate debris that poten-
tiates an osteolytic response (Bellare and Spector 2005). From the above,
wear of PE components is still a significant factor affecting the life of hip pros-
theses (Cooper et al. 1992, Alexander-Malahias et al. 2019).

1.1.6 Definition and features of wear


Wear refers to the occurrence of surface damage or material removal on one
or both of the two solid surfaces during kinematic contact (Grillini and Affatato

13
Introduction

2013). Abrasion, erosion, adhesion, and surface fatigue are a classification of


mechanical wear processes (Williams 2005).

In vivo, wear is assessed as penetration of the femoral head into the liner. The
linear penetration measurement includes creep (plastic deformation) and wear
(material removal). Creep does not produce particles initially (Galvin et al.
2010). Still, creep occurs early after the total hip replacement to increase the
head-liner contact region and decrease contact pressure (Penmetsa et al.
2006). One study showed that most of the creep behavior occurred within half
a year after implantation, which was termed the bedding-in phase, and con-
cluded that the penetration behavior was determined by creep within half a
year and attributed to wear after one year (Glyn-Jones et al. 2008).

1.1.7 Applications of wear measurement


At present, in the field of artificial joints, wear measurement is a primary current
focus because it involves materials from many prosthetic manufacturers. Wear
analysis can compare the property of different prostheses and implants and
predict long-term hip joint function (Takenaga et al. 2013) and the development
of osteolysis (Devane et al. 1995). Nonetheless, the essential applications of
wear measurement are to evaluate new materials, monitor patients (Langlois
et al. 2015), especially in young patients (Selvarajah et al. 2015), and provide
treatment recommendations for patients who follow up after THA, for example,
assessing when a patient is due for revision surgery (Rahman et al. 2012).

1.2 Wear measurement techniques


At present, many methods are used to detect polyethylene wear, which include
radiographic (Rahman et al. 2012) and non-radiographic methods. Different
principles and tools are applied in terms of corresponding techniques. Radio-
logical methods mainly utilize mathematical principles, formulas, etc., such as
geometry, vectors, matrices, etc., whose tools include radiological equipment
and corresponding software. Non-radiological methods are mainly concerned
with the combination of physics and mathematics, etc., such as gravity, coor-

14
Introduction

dinates, optics, etc., whose tools consist of physics equipment and corre-
sponding software. However, there is no consensus in terms of the accuracy
and precision of these various methods.

1.2.1 Classification of wear measurement techniques


Generally, wear assessments can be performed in vivo or in vitro within an
experimental setup using e.g. hip simulators. In vivo wear measurement tech-
niques are composed of conventional radiography (x-ray), RSA (stereo x-rays),
computed tomography (CT) (Goldvasser et al. 2014), and magnetic resonance
imaging (MRI) (Koff et al. 2019). According to the different analysis tools on
plain radiographs, wear assessments can be classified as manual assessment,
by a compass or a caliper, and computer-assisted techniques (Rahman et al.
2012). Depending on the wear measurement planes, wear assessments can
also be reported as two-dimensional techniques, which involve wear in the
frontal plane, and three-dimensional techniques, which include wear out of the
frontal plane (McCalden et al. 2005). However, in vitro, wear behavior of dif-
ferent bearings in THA is investigated by means of tribological methods, which
can be divided into friction and wear tests. Friction tests are used to determine
friction forces and friction coefficients (Di Puccio and Mattei 2015). Within wear
investigations, wear products are generated, their quantity is quantitatively de-
termined, the wear products are morphologically evaluated, and their biological
reactivity is examined. The wear can be determined by gravimetrical methods
or via changes in geometry (Kretzer et al. 2012). In general, wear measure-
ment techniques consist of a gravimetric method, coordinate measuring ma-
chine (CMM), shadowgraph (Grillini and Affatato 2013), and surface finishing
or debris characterization (Grillini and Affatato 2013).

1.2.2 Common wear measurement techniques


For in vivo experiments, radiographic methods are the most extensively used.
The first wear measurement method from radiography was described by
Charnley and Cupic in 1973 (Grillini and Affatato 2013), which was a uni-radi-
ographic method, comparing the contour of the femoral head to the contrast
wire of the cup on a single anteroposterior (AP) radiograph (Rahman et al.
15
Introduction

2012). Livermore et al. (1990) used a transparent template with concentric cir-
cles, including various radii in increments of 1 mm, and a compass to deter-
mine the center of the femoral head, which was the most regularly applied in
radiographic methods then, despite a manual method as well (Grillini and Af-
fatato 2013). The approach of Dorr and Wan (1996) drew an acetabular face
reference line to calculate linear wear, which was another significant manual
wear technique (Barrack et al. 2001). There were several manual assessment
methods (Charnley and Halley 1975, Pollock et al. 2001, Kang et al. 2003).

Many computer-assisted technologies have been developed to overcome the


weakness of manual methods by assessing the position of the femoral head
to the acetabulum. The principles of computer-assisted techniques are either
identifying the circles that best fit the femoral head and the acetabulum or an
edge-detection procedure that is used to access the ellipses that best fit the
contours of the femoral head and the acetabulum (Grillini and Affatato 2013).
The Manchester X-ray image analysis (MAXIMA) technique is one of the first
techniques for analyzing wear measurement of THA. Typical software pro-
grams are listed as follows: Hip Analysis Suite, PolyWare, Roentgen Mono-
graphic Analysis Tool (ROMAN), Rogan Hyper Ortho, Rogan View Pro-X, Ein
Bild Roentgen Analyse (EBRA), and so forth (Table 1)

Table 1 Typical software programs for wear measurement.

Software name Manufacturer Country


Hip Analysis Suite Virginia Commonwealth University America
https://innovationgateway.vcu.edu/technologies/biomedical/hip-analysis-suite.html
PolyWare Draftware Inc America
http://www.draftware.com/html/polyware.htm
ROMAN © Institute of Orthopaedics United Kingdom
http://www.cookedbits.co.uk/roman/
Rogan View Pro-X Rogan-De lft B.V. The Nertherlands
https://www.delftdi.com/hit/
EBRA University Innsbruck Austria
https://www.ebra.info/

For in vivo experiments, computed tomography (CT) and magnetic resonance


imaging (MRI) are both non-invasive tests. Due to the formations of artefacts,
increased scan times, data storage requirement, and finance, CT and MRI are
limited practically (Grillini and Affatato 2013).

16
Introduction

RSA was developed in 1975 by G. Selvik to study skeletal kinematics in vivo


(Selvik 1989). Further application of this special x-ray technology is to assess
and to measure in vivo polyethylene wear (Baldursson et al. 1979), which is
acknowledged as the most accurate method (Shareghi 2018). Classical
marker-based RSA technique involves the insertion of tantalum markers to the
implant and the surrounding bone. RSA image pairs are generated by two syn-
chronized x-ray tubes and the use of a calibration box, while the markers are
used to determine position and orientation of both rigid bodies: the implant
(using implant markers) and the bone (using intraoperatively injected tantalum
markers). When RSA is applied to measure polyethylene wear measurements,
the principle is to estimate polyethylene wear based on the penetration of the
femoral head relative to the acetabular component with serial radiographs of
the hip (McCalden et al. 2005, Bragdon et al. 2006b). Based on whether in-
serting markers to implant components, the methods for measuring wear by
RSA are RSA with markers (Marker-Based RSA) and RSA without markers
(Model-Based RSA), whose principles are different. For Marker-Based RSA,
wear measurements are conducted by the movement of the femoral center in
relation to the RSA marker in the PE component (Johanson et al. 2020). For
Model-Based RSA, wear measurements are obtained by using two reverse-
engineered (RE) / computer-aided (CAD) models (including an acetabular cup
and a femoral head), detecting the contours, identifying the center points, and
comparing the 3D motion of the center points (Börlin et al. 2006, M. Stilling
2012).

For in vitro experiments, the gravimetric method is gold-standard measure-


ment practice (Bills et al. 2007, Uddin 2014), which measures the weight
change of the prosthetic components from which the wear rate can be calcu-
lated (Grillini and Affatato 2013). Recently, in vitro, the coordinate measuring
machine (CMM), controlling the shapes and dimensions of produced elements
(Bills et al. 2007, Langton et al. 2014, Uddin 2014) and 3D Optical Scanners,
based on confocal laser scanning microscopy and triangulation (Valigi et al.
2017), have been used as novel methods for wear assessment, which have
been alternatives to the gravimetric method (Uddin 2014, Ranuša et al. 2017).

17
Introduction

1.2.3 Comparison between two dimensional (2D) techniques and three


dimensional (3D) techniques
There exist several in vivo wear measurement techniques using two dimen-
sional (2D) and three dimensional (3D) images, respectively (Goldvasser et al.
2014). Compared to 3D techniques, 2D techniques are simple (Martell and
Berdia 1997), which have more software available, do not require special
equipment, and have a short learning curve. For instance, some preoperative
planning software programs①② have wear measurement capabilities. On the
other hand, the advanced 3D techniques (Vandenbussche et al. 2010) add a
lateral view besides the AP view (Devane et al. 1997, Martell et al. 2003b) and
have been verified in vivo measurements. 3D techniques are more accurate
and can detect 10-20% more wear than 2D methods in terms of total wear
measurement (Olivecrona et al. 2002, Martell et al. 2003b). For example, RSA
is an accurate tool for the 3D in vivo evaluation of polyethylene (PE) wear in
THA (Ilchmann et al. 1995, Goldvasser et al. 2014) and is regarded as the gold
standard (Uddin et al. 2016).

1.2.4 Specific principles of wear measurement techniques in this ex-


periment
For RSA in the investigation, EGS-RSA (Roentgen stereophotogrammetric
analysis using elementary geometrical shape models) is the module for wear
measurement, which detects the contours of the sub-models, including femoral
head and acetabular cup models, and poses estimation of the models. The
concrete procedures in EGS-RSA wear analysis are as follows: (i) performing
image calibration of RSA image pairs, (ii) detecting contours in the left and
right RSA images, (iii) performing the pose estimation of EGS models, and (iv)
calculating wear between both models over several follow up scenes (Figure
1).

For 2Dwear in the experiment, mediCAD is the software program for wear meas-
urement, which uses a digital edge-detection algorithm to determine the center


Homepage mediCAD HECTEC GmbH, mediCADclassic: https://www.medicad.eu/
[07.10.2020, 17:43]

Homepage AGFA, IMPAX: https://www.agfa.com/corporate/ [07.10.2020, 17:43]

18
Introduction

of the acetabular cup and the femoral head and calculates the relative linear
wear value. The concrete procedures in the mediCAD wear analysis are as
follows: (i) scaling images, (ii) drawing reference lines, (iii) defining the head
center by 3 points, and (iv) calculation of wear (Figure 2).

Figure 1: Analytical environment of wear measurement using EGS-RSA. Yellow


circles represent fiducial markers. Green circles represent control markers. The
Orange circle represents an indicative marker. The green cup and red ball are
the EGS-RSA model in the software.

19
Introduction

Figure 2: Analytical environment of wear measurement using mediCAD® Classic. The tur-
quoise line is a reference line. The black and blue circles are respectively the centers of the
femoral head and the acetabular cup. The white sphere near the reference line is the cali-
bration sphere.

1.3 Gaps in clinical routine


Due to practical clinical constraints, there are a large number of gaps in clinical
routine for wear measurement. The clinical application of wear measurement
differs from basic research because it takes into account the practicability of
the experimental equipment and software, and is influenced by various indi-
vidual patient factors.

1.3.1 Applications of preoperative planning software programs


Preoperative planning software programs are regarded as an essential proce-
dure for total hip arthroplasty. It allows the surgeons to plan the operation pro-
cedure strategically, design the type and size of prosthesis, the position of the
prosthesis, the length of both lower limbs, and potential bone loss prior to sur-
gery. Furthermore, it thereby decreases the complications to ensure the safety
of operation (Atesok et al. 2015).

20
Introduction

Initially, conventional templating techniques were used in preoperative plan-


ning for total hip arthroplasty, which became impractical with the application of
digital image acquisition techniques (Kosashvili et al. 2009). The promotion
from conventional film-screen radiography to digital radiography has brought
about the development of many preoperative planning software programs
(Steinberg et al. 2016) (Table 2), including EndoMap (Siemens AG, Medical
Solutions, Erlangen, Germany) (Davila et al. 2006), IMPAX (Agfa Corporation,
Mortsel, Belgium) (Gonzalez Della Valle et al. 2008), mediCAD (mediCAD
Hectec GmbH, Landshut, Germany) (Hohle et al. 2015, Kutzner et al. 2017),
TraumaCad (BrainLAB Feldkirchen, Germany) (Worlicek et al. 2016), ZedHip
(Lexi Co., Tokyo, Japan) (Inoue et al. 2015), and so forth. On the other hand,
CT-based 3D preoperative planning software programs can enhance accuracy
(Viceconti et al. 2003, Sariali et al. 2012), however, at the cost of the patients’
exposure to higher dose irradiation and more expense (Steinberg et al. 2016).
Nonetheless, it is worth pointing out that not all preoperative software pro-
grams can be used to perform wear measurements.

Table 2 Common software programs for preoperative planning.

Software name Manufacturer Country

EndoMap Siemens AG Germany

https://www.endomap.de/

IMPAX Agfa Corporation Belgium

https://www.agfa.com/corporate/

mediCAD mediCAD Hectec GmbH Germany

https://www.medicad.eu/

TraumaCad BrainLAB Feldkirchen Germany

https://www.traumacad.com/

ZedHip Lexi Co. Japan

https://www.lexi.co.jp/en/

21
Introduction

At present, Devane’s PolyWare method (ARCH Development, Chicago, Illinois)


and Martell’s Hip Analysis Suite (Draftware Developers, Conway, South Caro-
lina) software have been the most popular methods (Stilling et al. 2012) to
assess the wear of the artificial joint. Nevertheless, these two software pro-
grams are specifically designed for wear measurement and are not commonly
used for preoperative planning. Therefore, if the wear measurement can be
performed through preoperative planning software programs, the requirement
of clinical practice will be approached to a higher degree.

In clinical routine, mediCAD software is one of the most commonly applied


preoperative planning software programs, which offer the opportunity to ana-
lyze implant component wear as well. Consequently, another crucial applica-
tion of the preoperative planning software programs is wear measurement,
which may be an alternative to RSA due to the limitation of RSA, namely, the
implantation of tantalum markers.

1.3.2 Causes of wear measurement using plain pelvic radiographs


For follow-up patients, it is still clinically accustomed to using plain pelvic radi-
ographs (standard a.p. radiographs), which are useful in long-term clinical fol-
low-up studies of PE wears and are most commonly used in vivo polyethylene
wear (Livermore et al. 1990). However, wear occurs in multiple directions and
planes, and the use of plain pelvic radiographs can only document wear on the
coronal plane. For that matter, why not use lateral radiographs additionally or
RSA to get wear measurements in multiple planes? One of the reasons is the
poor quality of lateral radiographs, which are not qualified for wear measure-
ment (Sychterz et al. 2001). Another reason is that RSA is not universally fea-
sible at any clinic. For the acquisition of the measuring technique to measure
wear by means of RSA, a budget in the 5-digit range is necessary, in contrast
with 2Dwear measurement techniques without a marked learning curve (Crock-
arell Jr and Snearly 2012).

The 2Dwear linear analysis can detect 90.1% of the total linear wear detected
by the 3D analysis and the repeatability of 3D analysis is poor (Martell et al.
2003a). On the other hand, wear along the x-axis and y-axis directions (medial
and proximal) is widely regarded as where the majority of wear occurs

22
Introduction

(McCalden et al. 2005). A study also indicated that femoral head penetration
of 95% of patients in the research occurred in the AP plane (Sychterz et al.
1999). In two studies, one used cemented cups (Derbyshire and Barkatali
2017) and the other used cementless cups (Stilling et al. 2010). Their 2Dwear
measurements with AP were both compared with RSA, and the accuracy was
similar. Another study showed the line wear in the AP plane could afford a
predictable estimation of the total wear volume (Ilchmann et al. 2012). Further-
more, compared to direct measurements from retrieved components, AP im-
ages were also applicable to detect 2-dimensional in vivo wear (Parran et al.
2018).

Not many researchers have addressed the problem of comparing 2D wear de-
tection with 3Dwear detection. And little is known about the interchangeability
between the 3D RSA method and computerized software methods using plain
radiographs. For example, a study compared three methods (the simple and
noncomputerized Scheier-Sandel, Charnley-Duo methods, and the computer-
ized EBRA method) with RSA and found that the EBRA method had the best
accuracy (Ilchmann et al. 1995). In addition, a study comparing two RSA tech-
niques (3D) and three standard radiographic techniques (2D) for measurement
of wear demonstrated that the 2D techniques were less accurate (Schewelov
et al. 2004). Another comparative study with 5 years of follow-up showed
greater wear outcomes than RSA at each time point measured with Martell Hip
Analysis Suite software, but the difference between the two methods was re-
duced after 2 years (Bragdon et al. 2006a). The interchangeability between
the 3Dwear method and 2Dwear detection is still unresolved.

1.3.3 Influencing factors of artificial joint wear


There are many influencing factors of artificial joint wear, either increasing
wear or decreasing wear, including age, activity level, head size, fixation mode
(cemented or uncemented), prosthesis type, liner thickness, femoral offset,
head type, gender, and weight (Devane and Horne 1999).

In most instances, the two factors, young and active patients (Tikhilov et al.
2018), are liable to increase wear. For head size, the femoral head of larger
size will lead to more wear theoretically. However, a 10 to 14 year follow-up

23
Introduction

showed no relation between femoral head size and linear wear rate, and larger
femoral heads were correlative to more volumetric wear (Lachiewicz et al.
2016). For fixation mode, according to knowledge, cemented fixation mode
generates less wear. Nevertheless, when HXLPE was employed, the PE wear
rate was similar between cemented sockets and uncemented liners (Morita et
al. 2017). Prosthesis type, liner thickness, head type are all design factors. A
study showed that design factors might be pronounced regarding the risk of
revision (Johanson et al. 2017). For the femoral offset, the restored offset can
cause less wear. A clinical study involving implants on both sides that were
similar except for implant offset showed that the more closely restored femoral
component, which was corresponding to preoperative hip biomechanics, de-
creased polyethylene wear (Sakalkale et al. 2001). Gender is a vague influ-
encing factor. A study identified a gender-dependent discrepancy in wear ac-
cording to head size, with 32 mm heads being linked with increased wear in
females (Stambough et al. 2016). A randomized controlled trial demonstrated
that there was no significant difference in the conventional polyethylene group,
and no significant difference in the cross-linked polyethylene group, regarding
gender factor (McCalden et al. 2009). Weight is correlated to artificial joint wear,
and obesity seems to be a risk influencing factor. A multiple factor analysis
indicated that weight was one of the four most dominant variables (Floerke-
meier et al. 2017).

There are some other influencing factors, for example, pelvic position and ac-
etabular cup position with the parameters: inclination and anteversion. A ret-
rospective study compared the relationship between the pelvic tilt angle, cup
anteversion, cup inclination, and polyethylene wear in the conventional poly-
ethylene liners group and the highly cross-linked polyethylene liners group in
the supine and standing positions. This study concluded that the pelvic tilt an-
gle correlated with the annual rate of polyethylene linear wear in the conven-
tional polyethylene liners group, but the mechanism was unknown (Tezuka et
al. 2015). Recently, a ten to sixteen-year follow-up indicated that the cup ab-
duction angle and anteversion were correlative to the linear wear rate in THA
(Cheung et al. 2019).

24
Introduction

1.3.4 Correlation of pelvic positions and wear measurement


Many factors can affect wear measurement, for example, staff experience, dif-
ferent prosthetic composite, various software programs, but little attention has
been paid to positions of the lower extremity. The change of patient positions,
for example, tilt, lateral tilt, or rotation of the pelvis, may influence the accuracy
of wear measurement because the position of the pelvis may not be invariable
and the wear plane may not consistently be parallel to the radiographic plane
at every x-ray examination (Derbyshire 2018). A study indicated that the ori-
entation of the pelvis might be inconsistent with each x-ray, causing changes
in the wear plane view and affecting the results of linear wear measurements.
This situation was more significant in the offset cup design. Another study pre-
sented a mathematical approach that could be used to revise radiographic
wear measurements for changes in pelvic orientation (Derbyshire 2018). In
clinical practice, when a patient has a spine or hip disease, the pelvic position
is often unneutral during filming. A plausible theoretical explanation for the sit-
uations is that the radiographic shadows of cups vary with pelvic positions of
displacements, which can make the basis for automatic edge detection differ-
ent (Stilling et al. 2009). A study used a human pelvis fixed with a polyethylene
cup with a spherical, equatorial contrast wire and made the pelvis gradually tilt
around the vertical and horizontal axes. The study utilized the EBRA software
to measure wear and found that wear measurements were slightly affected by
pelvic tilt, possibly due to systematic error (Ilchmann et al. 1998). A study em-
ploying a computer program to design virtual pelvic radiographs and simulate
variations in pelvic orientation and wear direction demonstrated that errors
caused by pelvic positions were small: 0.4% underestimated for the simulated
pelvic orientation group and 8.5% underestimated for the simulated wear di-
rection group (Foss et al. 2008). Nonetheless, each of the wear measurements
in Foss et al. (2008) was merely on a radiograph instead of a follow-up radio-
graph and a reference radiograph, which was not entirely consistent with clin-
ical reality. These above mentioned are only available literatures describing
the correlation between pelvic positions and wear measurement, which is cur-
rently unclear (Ilchmann et al. 1998, Foss et al. 2008, Derbyshire 2018).

25
Introduction

1.4 Aim, hypotheses, and innovation of this study


This phantom-model study aimed to first assess the interchangeable applica-
bility of 2Dwear and 3Dwear methods by quantifying the accuracy and reproduci-
bility of both methods, and then further identify how far the two detection meth-
ods were affected by the positions of the pelvis.

The hypothesis was that the 3Dwear detection method would show superior pre-
cision and accuracy compared to the 2Dwear detection method (Hypothesis 1).

In addition, the effect of pelvic malpositioning on the PE wear measurements


for both methods should be investigated within an experimental phantom
model, and 3Dwear detection methods were not sensitive to pelvic misalignment
(Hypothesis 2).

There were three innovation points in this study. The first point was that com-
paring the common clinically used method (preoperative planning software)
with the gold standard method (RSA). On the other hand, in terms of experi-
mental design, the pelvic orientation factor was concerned, which was more in
line with the actual clinical practice. The third point was that different wear
value ranges were arranged in the experimental protocol.

26
Material and Methods

2 Material and Methods


The current investigation involved the comparison of two measured values and
one true value (set value), adopting two different methods. In order to under-
stand the experimental process more clearly, an experiment flowchart was il-
lustrated (Figure 3). Prior to undertaking the investigation, this experiment
consisted of two sets of measurement setups: RSA setup (3Dwear) and con-
ventional x-ray setup (2Dwear). A phantom device was integrated into the meas-
urement setup and constructed to be a laboratory simulation of PE linear wear
in 3 degrees of freedom. In the final stage of the study, different pelvic positions
were compared after anteroposterior (AP) and RSA images were acquired and
analysed consecutively for each simulated wear position for each method. Pre-
cision (standard deviation) and accuracy (bias) for wear measurements were
assessed. The section would be described in the following sequence: meas-
urement setup, phantom model, measurement protocol, data analysis, and
statistics.

27
Material and Methods

Figure 3: Experimental flowchart (In the narrative that follows, 3D wear is used to represent
the 3D technique of RSA in this experiment, and 2Dwear is used to represent the 2D tech-
nique in this experiment.)

2.1 Measurement setup


For RSA radiological imaging, RSA setup consisted of one ceiling-fixed roent-
gen tube (Multix RD 82477-01 Vertix ACS, Siemens, Berlin, Germany) and
one mobile roentgen tube (Mobilett Plus, Siemens, Berlin, Germany), which
were positioned at an angle of 40°to each other and 1.4 m over the calibration
box Umea Cage 43 (RSA BioMedical Innovations AB, Umea, Sweden), with a
setting of 80 kV and 5 mAs (Figure 4A). For classical radiological imaging,
plain AP radiographs were obtained by ceiling-fixed roentgen tube (Multix RD
82477-01 Vertix ACS, Siemens, Berlin, Germany), with a setting of 90 kV and
4 mAs (Figure 4B).

This setup was able to capture RSA as well as conventional x-ray images par-
allelly (Figure 4C). For each position of simulated wear, radiographs of each

28
Material and Methods

group would be obtained in the same phantom setting when the phantom was
not moved from the radiology table. The radiological images of RSA and plain
AP were obtained sequentially by shifting the position of the radiology table in
the horizontal direction and adjusting the height of the ceiling-fixed roentgen
tube.

A) B)

C)

Figure 4: (A) uniplanar RSA measurement setup (patients in supine position) using a
ceiling-fixed and mobile roentgen tube (i.e. RSAleft) (Mobilett Plus, Siemens, Berlin,
Germany). (B) classical standard x-ray setup for AP x-ray in the supine position using
one ceiling-fixed roentgen tube (Multix RD 82477-01 Vertix ACS, Siemens, Berlin, Ger-
many). (C) The conversion process of two systems: When x-raya.p. moves to the loca-
tion of RSAright, system B is converted to system A.

29
Material and Methods

2.2 Phantom model


The phantom model (Figure 5) consisted out of a micrometer screw and a
femoral bone-implant-model (FBIM), which could be moved precisely around
three degrees of freedom (DOF) relative to an acetabular bone-implant-model
(ABIM). The bone-implant-model consisted of an uncemented, 58-mm titan
cup (Peter Brehm, Weisendorf, Germany) and an uncemented stem (Peter
Brehm, Weisendorf, Germany) with a 32-mm cobalt-chromium head (Peter
Brehm, Weisendorf, Germany) (Figure 6) implanted into a foam femur saw-
bone. The cup was placed in approximately 44.5°of abduction and 14.4°of
anteversion (Figure 7), which were measured after prosthesis implantation by
mediCAD. According to Lewinnek’s research (Abdel et al. 2016), the recom-
mended standard was that the cup inclination and anteversion with the de-
grees of 40° ± 10° and 15° ± 10°, respectively. Therefore, the cup position
could meet the experiment requirement. This experiment was a wear simula-
tion, so there were no polyethylene liners between the head and the cup, which
had enough space to set wear values for different sizes. The pelvis was in a
neutral position, with the anterior superior iliac spine and symphysis pubis in
the same vertical plane. The femoral stem was attached to a micrometer screw,
which had a group of three dial micrometers with a resolution of 0.01 mm (Pe-
ter Brehm, Weisendorf, Germany) (Figure 8) and could simulate three trans-
lational migration. The matching polyethylene liner was first placed in the ace-
tabular cup so that the two centers of the femoral head and the acetabular cup
coincided. Then the liner was removed so that the center of the femoral head
was very close to the center of the acetabular component, which simulated
zero wear position. During the experiment, three dial micrometers in the mi-
crometer screw were manipulated to simulate three direction wear from supe-
rior, medial, and posterior directions (Figure 9) along with a defined distance
while the head was kept fixed.

30
Material and Methods

Figure 5: A phantom model with foam sawbones, total hip prostheses, and dial microme-
ters. The phantom model consists of an uncemented, 58-mm titan cup (Peter Brehm, Wei-
sendorf, Germany) and an uncemented stem (Peter Brehm GmbH, Weisendorf, Germany)
with a 32-mm cobalt-chromium head (Peter Brehm GmbH, Weisendorf, Germany) im-
planted into a foam hip sawbone. The pelvis is in a neutral position, with the anterior superior
iliac spine and symphysis pubis in the same vertical plane. The femoral stem is attached to
a group of three dial micrometers with a resolution of 0.01 mm (Mitutoyo Deutschland
GmbH, Neuss, Germany).

Figure 6: A 58-mm titan cup (Peter Brehm, Weisendorf, Germany), and an uncemented
stem (VECTOR-TITAN, Peter Brehm, Weisendorf, Germany), and a 32-mm cobalt-chro-
mium head (Peter Brehm, Weisendorf, Germany).

31
Material and Methods

Figure 7: Cup position with the inclination 44.5 degrees and the anteversion 14.4 degrees

Figure 8: Micromanipulator device (Mitutoyo Deutschland GmbH, Neuss, Germany) in (A)


lateral and (B) transversal views. By the three screws, the attached Bone-Implant-Model
can be moved along a defined distance.

32
Material and Methods

A) B)

Figure 9: Global coordinate system with three planes (mediolateral (m.l.), craniocaudal (c.c.),
anteroposterior (a.p.)). (A) RSA: Origin = “Center” of migrating model at reference time point
T0, Direction = Aligned with calibration box. (B) The femoral head moved in superior, medial,
and posterior directions during the experiment.

2.3 Measurement protocol


Three wear categories were predefined according to the study protocol of
Stilling et al. (Stilling et al. 2012). Each category included five 3D wear vectors:
low wear (0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, and 0.05 mm), medium wear
(0.1 mm,0.2 mm, 0.3 mm, 0.4 mm, and 0.5 mm) and high wear (1 mm, 2 mm,
3 mm, 4 mm, and 5 mm). The x, y, and z axes were adjusted the same distance
according to the protocol (Table 3). In the experiment, the x, y, and z axes
matched the mediolateral, craniocaudal, and anteroposterior directions, re-
spectively (Figure 10). The translations along the medial-lateral axis (x) and
superior-inferior axis (y) composed in-plane motions, and the translations
along the anterior-posterior axis (z) composed out-of-plane motions. For each
set wear value, the radiological images of RSA and plain AP were obtained
sequentially. The above experimental steps were repeated five times. Below
was one example of the measurement protocol (Figure 11).

Seven experiments were performed to simulate the change of the pelvic posi-
tions of patients during the shoot of x-ray separately, which corresponded to
seven different pelvic positions, including neutral, tilted ±5 deg, rotated ±5 deg,
lateral tilted (obliquity) ±5 deg (Figure 12). In addition to adjusting the direc-
tions of the pelvis in the phantom model, the other procedures were identical.

33
Material and Methods

Each experiment was repeated five times as well. Below was an overview of
the experimental process (Figure 13).

Table 3 Wear protocols (Unit: m).

Low wear Medium wear High wear


10,10,10 100,100,100 1000,1000,1000
20,20,20 200,200,200 2000,2000,2000
30,30,30 300,300,300 3000,3000,3000
40,40,40 400,400,400 4000,4000,4000
50,50,50 500,500,500 5000,5000,5000

Figure 10: Wear protocol illustrated by the Global coordinate system. Blue line represents
distance moved on the x-axis in the wear protocol. Green line represents distance moved
on the y-axis in the wear protocol. Red line represents distance moved on the z-axis in the
wear protocol. Yellow line represents the total distance moved by the x, y, and z axes in the
wear protocol, expressed as a vector.

34
Material and Methods

Figure 11: Schematic diagram of the measurement protocol.

Figure 12: Seven experiments based on different positions of the pelvis.

35
Material and Methods

Figure 13: Steps of the experimental method.

2.4 Data analysis


2Dwear analysis out of standard a.p. x-rays was performed according to the
instructions of use for preoperative planning software (mediCAD® Classic, v5.1,
mediCAD® Hectec GmbH, Landshut, Germany), and 3Dwear analysis with RSA
software package (MBRSA version 4.1, RSAcore, LMUC, Leiden, The Neth-
erlands), adopted EGS-RSA module. Within the first procedure, both x-rays
were calibrated according to manufacturer guidelines.

Wear analysis using EGS-RSA (3Dwear) utilized algorithms to fit the head and
cup models to the regions of interest marked on the peripheries of the head
and cup in the stereo radiographs. The process of 3Dwear analysis included to
generate a new RSA scene, to perform image calibration, to detect contours
in the images, to detect contours in the images, to achieve the pose estimation,
and to calculate wear between several scenes (Figure 1).

Wear analysis using standard 2D x-rays (2Dwear) utilized a computerized


method featuring a digital edge-detection algorithm to match circles and ellip-
ses to the peripheral shadows of the femoral head and acetabular cup (Stilling
et al. 2010). The process of 2Dwear analysis included to insert and scale images,

36
Material and Methods

to draw reference lines, to define the head center by 3 points, to define cup
center by 3 points, and calculation of wear (Figure 2).

In the last procedure, the wear measurements of two methods between 3Dwear
and 2Dwear were recorded, respectively.

2.5 Statistics
The statistics were processed by SPSS (Version 23, SPSS Inc., Illinois, USA).
According to different statistical purposes, the statistical methods included:
paired t-test, one Way ANOVA, Wilcoxon matched-pair signed-rank test, and
Kruskal-Wallis test. The paired t-test was applied between each paired wear
group to assess the interchangeability of the methods above. Paired t-test or
Wilcoxon matched-pair signed-rank test was applied between each paired
wear group or position, according to whether the differences between the two
groups or positions matched the normal distribution. One Way ANOVA or
Kruskal-Wallis test was applied among each wear group from all wear posi-
tions, according to whether the differences matched the normal distribution.

Paired t-test and Wilcoxon matched-pair signed-rank test were used to answer
the hypotheses: 1) The 3Dwear detection method would show superior precision
and accuracy compared to the 2Dwear detection method; 2) 3Dwear detection
methods were not sensitive to pelvic misalignment. One Way ANOVA and
Kruskal-Wallis test were used to answer the hypothesis 2).

For precision and accuracy, precision was expressed as the standard devia-
tion (SD) of the repeated measures, and accuracy was expressed as the bias
of measured values of wear measurement, whereas the bias was given a def-
inition with the average difference between the measured and true values.

Box plots were applied to observe possible outliers and extreme values within
experiment analysis. Special scatter plots, with limits of agreements (LOA),
were calculated to assess the interchangeable applicability of 2Dwear and
3Dwear detection methods (Bland and Altman 1986). (LOA) = mean difference
± 1.96 × SD

37
Results

3 Results
This study aimed to assess the interchangeable applicability of wear detection
between 2Dwear and 3Dwear methods and the effect of pelvic malpositioning on
the results of wear measurement. Using the methods described above, differ-
ent wear measurements were obtained.

The results were organized into three sections: 3Dwear measurement result,
2Dwear measurement result, and comparison between 3Dwear and 2Dwear meas-
urement results. Different aspects of each section would be illustrated.

3.1 3Dwear measurement result


Above all, the influence of pelvic position factors on the results of 3Dwear meas-
urement would be elaborated as follows. In general, for the three individual
axes, 3Dwear box plots were presented based on different pelvic positions. Fur-
ther statistical analysis was applied in two paired positions, respectively, to
evaluate the effect of the other six pelvic positions on the pelvic neutral position.

For the X axis (medio-lateral axis), the p values of two relative positions were
both less than 0.05 (pelvic tilted back 5-degree position vs. pelvic neutral po-
sition, pelvic lateral tilted left 5-degree position vs. pelvic neutral position) (Fig-
ure 14).

For the Y axis (superior-inferior axis), the p values of three relative positions
were all less than 0.05 (pelvic rotation right 5-degree position vs. pelvic neutral
position, pelvic lateral tilted left 5-degree position vs. pelvic neutral position,
pelvic lateral tilted right 5-degree position vs. pelvic neutral position) (Figure
15).

For the Z axis (posterior-anterior axis), the p values of two relative positions
were both less than 0.05 (pelvic lateral tilted left 5-degree position vs. pelvic
neutral position, pelvic lateral tilted right 5-degree position vs. pelvic neutral
position) (Figure 16).

For 3Dwear as a whole, the p-value between pelvic lateral tilted left 5-degree
position and the pelvic neutral position was less than 0.05 (Figure 17). To

38
Results

indicate each wear group in each pelvic position further, the differences among
the low wear groups were significantly less than the other two groups (Figure
18). In further statistical analysis, the low wear group was not significantly dif-
ferent among all wear positions (p = 0.235). Nevertheless, medium and high
wear groups were significantly different (both p < 0.05).

39
Results

Figure 14: Box plot of 3Dwear for the X axis (The x-axis shows different wear positions, and
the y-axis shows the difference between measurement value and true value. Stars (*): p <
0.05).

Figure 15: Box plot of 3Dwear for the Y axis (The x-axis shows different wear positions, and
the y-axis shows the difference between measurement value and true value. Stars (*): p <
0.05).

40
Results

Figure 16: Box plot of 3Dwear for the Z axis (The x-axis shows different wear positions, and
the y-axis shows the difference between measurement value and true value. Stars (*): p <
0.05).

Figure 17: Box plot of 3Dwear (The x-axis shows different wear positions, and the y-axis
shows the difference between measurement value and true value. Stars (*): p < 0.05).

41
Results

Figure 18: Box plot of 3Dwear among each wear group (The x-axis shows different wear
positions, and the y-axis shows measurement value minus true value. The green, orange,
blue boxes represent low, medium, and high wear groups, respectively).

3.2 2Dwear measurement result


Generally, 2Dwear measurements based on different pelvic positions were com-
pared, the patterns of boxes in which varied significantly (Figure 19). Relative
to the pelvic neutral position, p values from four other positions were less than
0.05 (pelvic tilt forward 5-degree position vs. pelvic neutral position, pelvic tilt
back 5-degree position vs. pelvic neutral position, pelvic rotation right 5-degree
position vs. pelvic neutral position, pelvic lateral tilted right 5-degree position
vs. pelvic neutral position).

To indicate each wear group in each pelvic position, the differences among the
medium groups were significantly less than the other two groups (Figure 20).
The medium wear group was not significantly different among all wear posi-
tions (p = 0.068). Nevertheless, low and high wear groups were significantly
different. (both p < 0.05)

42
Results

Figure 19: Box plot of 2Dwear (The x-axis shows different wear positions, and the y-axis
shows the difference between measurement value and true value. Stars (*): p < 0.05).

Figure 20: Box plot of 2Dwear among each wear group (The x-axis shows different wear
positions, and the y-axis shows measurement value minus true value. The green, orange,
blue boxes represent low, medium, and high wear groups, respectively).

43
Results

3.3 Comparison between 3Dwear and 2Dwear measurement re-


sults
The measurement objects measured in 3Dwear and 2Dwear were identical, so
the measurement results in both methods could be comparable. In addition,
since the pelvic neutral position was the initial position for comparison with
other pelvic positions, the data of the pelvic neutral position was listed sepa-
rately.

In this section, the wear measurement results were presented with three dif-
ferent aspects: the data of the pelvic neutral position, the data of all pelvic
positions as a whole, the data of all pelvic positions individually.

3.3.1 Comparison between 3Dwear and 2Dwear measurement results in


the pelvic neutral position
The mean value and standard deviation in each group illustrated 3Dwear was
significantly better than 2Dwear (Table 4). For precision, on the whole, the pre-
cision value of 3Dwear was 0.046 mm, and the precision value of 2Dwear was
0.111 mm, including the precision of each wear group (Table 5). For accuracy,
on the whole, the accuracy value of 3Dwear was 0.024 mm, and the accuracy
value of 2Dwear was 0.112 mm, including the accuracy of each wear group (Ta-
ble 6).

P-value in the medium wear group was 0.239, which showed that the medium
wear group was not significantly different between 2Dwear and 3Dwear. Never-
theless, low and high wear groups were significantly different (Both p = 0.00).

44
Results

Table 4 Mean value and standard deviation. (Unit: mm)

Groups 2Dwear 3Dwear


L1 0.132 ± 0.054 0.052 ± 0.018
L2 0.078 ± 0.046 0.053 ± 0.032
L3 0.118 ± 0.070 0.059 ± 0.036
L4 0.196 ± 0.097 0.091 ± 0.050
L5 0.180 ± 0.118 0.090 ± 0.043
M1 0.194 ± 0.138 0.161 ± 0.040
M2 0.378 ± 0.044 0.302 ± 0.041
M3 0.462 ± 0.065 0.433 ± 0.044
M4 0.580 ± 0.145 0.586 ± 0.030
M5 0.734 ± 0.122 0.731 ± 0.034
H1 1.536 ± 0.115 1.431 ± 0.040
H2 2.974 ± 0.161 2.893 ± 0.032
H3 4.500 ± 0.122 4.315 ± 0.047
H4 5.970 ± 0.138 5.702 ± 0.044
H5 7.190 ± 0.129 7.004 ± 0.102

Table 5 Precision of 2Dwear and 3Dwear. (Unit: mm)

2Dwear: SD = 0.111 3Dwear: SD = 0.046


SDlow = 0.082 SDlow = 0.037
SDmedium = 0.111 SDmedium = 0.038
SDhigh = 0.134 SDhigh = 0.058

Table 6 Accuracy of 2Dwear and 3Dwear. (Unit: mm)

2Dwear: Bias = 0.112 3Dwear: Bias = 0.024


Biaslow = 0.098 Biaslow = 0.027
Biasmedium = 0.045 Biasmedium = 0.018
Biashigh = 0.191 Biashigh = 0.026

3.3.2 Comparison between 3Dwear and 2Dwear measurement results in all


pelvic positions as a whole
In this section, two software measurements from seven pelvic positions were
compared together. This study aimed to compare and analyze 2D wear and
3Dwear with more data.

As observed, conformity between 3Dwear and 2Dwear was visible in some cases,
especially in medium wear group (Figure 21). There was an outlier value from
the high wear group, which might happen due to the loosening of the experi-
mental device during the experiment process.

The box plot and statistical analysis were adopted to assess the interchange-
ability of the two methods. The differences between measurement value and

45
Results

true value were highlighted (Figure 22). In statistical analysis, the paired t-test
or Wilcoxon matched-pair signed-rank test was applied between each paired
wear group from seven pelvic positions according to whether the difference
between the two methods matched the normal distribution. P values in all three
wear groups were all less than 0.05, which showed that all three wear groups
were significantly different between 2Dwear and 3Dwear.

To further evaluate precision and accuracy overall, all the data from seven
pelvic positions was regarded as a whole. There was a significant difference
in precision and accuracy between the two methods (Table 7, Table 8). Nev-
ertheless, with regard to the accuracy, the medium wear group in 2Dwear was
relatively accurate compared to 3Dwear.

46
Results

Figure 21: Bland-Altman plot between 2Dwear and 3Dwear (The x-axis shows the average of
the measurements of two methods, and the y-axis shows the difference between the meas-
urements of two methods. The dashed black lines denote the 95% limits of agreement, the
blue line represents the bias from 0, and the dashed red line, at y = 0, represents the line
of perfect average agreement. The green, orange, and blue dots represent low, medium,
and high wear groups, respectively).

Figure 22: Box plot between 2Dwear and 3Dwear (The x-axis shows different wear groups,
and the y-axis shows measurement value minus true value. The blue and green boxes rep-
resent 2Dwear and 3Dwear, respectively. Stars (*): p < 0.05).

47
Results

Table 7 Precision of 2Dwear and 3Dwear from seven pelvic positions. (Unit: mm)

2Dwear: SD = 0.206 3Dwear: SD = 0.043


SDlow = 0.107 SDlow = 0.033
SDmedium = 0.154 SDmedium = 0.038
SDhigh = 0.304 SDhigh = 0.054

Table 8 Accuracy of 2Dwear and 3Dwear from seven pelvic positions. (Unit: mm)

2Dwear: Bias = 0.159 3Dwear: Bias = 0.017


Biaslow = 0.146 Biaslow = 0.025
Biasmedium = 0.069 Biasmedium = 0.011
Biashigh = 0.263 Biashigh = 0.016

3.3.3 Comparison between 3Dwear and 2Dwear measurement results in all


pelvic positions individually
In general, the pattern of 3Dwear box plot did not vary with different pelvic posi-
tions distinctly with respect to 2Dwear (Figure 23). Statistical analysis of the
paired t-test or Wilcoxon matched-pair signed-rank test was applied between
each paired wear position. For 3Dwear, the p-value between pelvic lateral tilted
left 5-degree position and the pelvic neutral position was less than 0.05. For
2Dwear, p values of the four relative positions were all less than 0.05 (pelvic
tilted forward 5-degree position vs. pelvic neutral position, pelvic tilted back 5-
degree position vs. pelvic neutral position, pelvic rotated right 5-degree posi-
tion vs. pelvic neutral position, pelvic lateral tilted right 5-degree position vs.
pelvic neutral position).

48
Results

Figure 23: Box plot between 2Dwear and 3Dwear (The x-axis shows different wear positions,
and the y-axis shows measurement value minus true value. The blue and green boxes rep-
resent 2Dwear and 3Dwear, respectively. Stars (*): p < 0.05).

49
Discussion

4 Discussion
THA is a satisfactory surgery, which has dramatically improved the quality of
life of patients. However, wear remains an inevitable factor and a major unre-
solved question, although there are many available wear measurement meth-
ods. RSA is not a standard wear measurement tool because it requires special
measurement equipment (2 x-ray sources, calibration box) and leads to addi-
tional radiation exposure for patients. This limits its further clinical application.
In clinical practice, standard a. p. radiographs of the pelvis are often used for
follow-up, which can be widely applied in any follow-up time points instead of
RSA. However, standard a. p. radiographs are not always consistently stand-
ard because the pelvic positions of patients are not acceptable invariably. The
study also focused on the impact of pelvic orientation on wear measurements.

4.1 Restating the findings of the main results


This experiment used 2D and 3D technologies for the measurement of wear
simulations and also designed the effect of different pelvic positions on the
results. The current study found that 3D technology was better than 2D tech-
nology in terms of accuracy and precision; however, 2D technology could be
an alternative to 3D technology to some extent. Another important finding was
that 3D technology was relatively unaffected by pelvic misalignment compared
to 2D technology. These results were consistent with previously mentioned
hypotheses, which could bring about positive implications: the application of
2D technology was adequate in clinical practice, but attention needed to be
paid to the impact of changes in pelvic malposition.

4.2 Comparison to other studies of wear measurement


There are many techniques for wear measurement in the field of artificial joints,
whose technical principles, scopes of application, accuracy, precision, and
equipment cost are various. Four aspects of these experimental results are
compared with previous studies: individual 2D techniques, individual 3D tech-
niques by RSA, combined 2D and 3D techniques, and studies involving pelvic
orientations.

50
Discussion

4.2.1 Comparison to other individual 2D techniques by computer-as-


sisted software programs
Most 2D methods by computer-assisted software programs in wear assess-
ment adopt digital edge detection techniques, whose principles are similar, so
there are not many comparisons between different 2D software programs. An-
other reason is that due to different study designs and various definitions of
accuracy and precision, it is difficult to compare the results directly (Stilling et
al. 2012). A study comparing four computer-assisted methods, including Mar-
tell Hip Analysis suite 7.14, Rogan HyperOrtho, Rogan View Pro-X, and Ro-
man v1.70, showed that the Roman method was the most precise (Geerdink
et al. 2008).

In the study, the precision and accuracy of 2Dwear (mediCAD) in wear meas-
urement were presented. It was more convenient in the process of obtaining
images and analyzing data for 2Dwear. Although there was a gap between
2Dwear and 3Dwear in terms of precision and accuracy (Table 7, Table 8), 2Dwear
might be an alternative method to assess wear detection in some respects,
which was consistent with other 2D techniques (Crockarell Jr and Snearly
2012, Stilling et al. 2012, Langlois et al. 2015, Derbyshire and Barkatali 2017).

For the neutral pelvic position, precision in 2Dwear was 0.111 mm, and accuracy
in 2Dwear was 0.112 mm. This solution method could be applied without diffi-
culty to clinical situations. In a report on the wear rate (Teeter et al. 2017), the
average wear rate in crosslinked polyethylene was 0.04 mm/year and the av-
erage wear rate in conventional polyethylene was 0.08 mm/year, which were
within the range of experimental wear protocol.

4.2.2 Comparison to other individual 3D techniques by RSA


There are two types of RSA, including Marker-Based RSA and Model-Based
RSA. The common Model-Based RSA (MBRSA) is EGS-RSA (Roentgen ste-
reophotogrammetric analysis using elementary geometrical shape models),
CAD Model-Based RSA (Roentgen stereophotogrammetric analysis using
computer-aided design), and RE Model-Based RSA (Roentgen stereophoto-
grammetric analysis using reverse-engineered model), which can be all used
in wear measurements (Lorenzen et al. 2013, Jacobsen et al. 2018). Marker-

51
Discussion

based RSA is a conventional and gold standard RSA method in need of the
insertion of tantalum markers. To overcome the inconveniences of the Marker-
Based RSA, Model-Based RSA for CAD and reverse-engineered shapes,
which is generated by a laser or optical scanning design model of the implant,
is developed. To further facilitate the CAD model-based RSA and RE model
RSA method, EGS-RSA is introduced by utilizing geometrical bodies to calcu-
late migration by rigid body kinematics.

EGS-RSA, which was an approach used in this study, was regarded to have
interchangeable applicability compared to the gold standard Marker-Based
RSA method in Author's laboratory (Jacobsen et al. 2018). On the other hand,
for the measurements in the frontal plane, the precision and accuracy were
similar between EGS-RSA and RE Model-Based RSA (Stilling et al. 2012).
Another research comparing four RSA methods in wear measurements
demonstrated that the marker-less RSA method was feasible in terms of cost,
time, and security (Börlin et al. 2006). On the other hand, similar to previous
research (Kärrholm et al. 2006, Stilling et al. 2012), the RSA wear measure-
ment along the anterior-posterior axis (z) had the worst precision. One reason
was that the z-axis from the sagittal plane consisted of the out-of-plane motion,
which was difficult to measure precisely. Another reason was that the femoral
head might touch the acetabular cup in the z-axis direction for high wear
groups.

For neutral pelvic position, precision in RSA was 0.046 mm, and accuracy in
RSA was 0.024 mm, which were both close to other RSA measurement stud-
ies (Ryd et al. 2000, Pineau et al. 2010, Li et al. 2014). Therefore, in experi-
mental phantom studies, EGS-RSA was sufficient to represent 3D RSA tech-
niques, avoiding adopting Marker-Based RSA or other Model-Based RSA.

4.2.3 Comparison to other combined 2D and 3D techniques


At present, there are some similar comparative studies between 2D and 3D
techniques, which are in the absence of comparing preoperative planning soft-
ware programs with RSA. There was two research between PolyWare for
2Dwear and RSA for 3Dwear, indicating that PolyWare was an alternative to RSA,
despite being less accurate and precise (Stilling et al. 2010, Stilling et al. 2012).

52
Discussion

However, PolyWare was exclusively devised for wear measurement and not a
preoperative planning software program. Some similar situations occurred in
other combined 2D and 3D technique studies (Sychterz et al. 1999, Hui et al.
2003, Schewelov et al. 2004). So this was the first time that the research had
presented the problem of comparing preoperative planning software programs
with RSA in wear measurement to improve clinical convenience further.

In this experiment, although there was a significant difference between 2Dwear


and 3Dwear, 2Dwear by the preoperative planning software program was still an
excellent alternative method to 3Dwear and had interchangeable applicability in
some aspects. For example, medium wear group in 2Dwear had relatively good
accuracy and precision (Table 7, Table 8) and was not susceptible to lower
extremity positions (Figure 20).

4.2.4 Comparison to other studies involving pelvic orientations


To date, for RSA, there has been no research about pelvic orientations and
wear measurement, which tends to focus on the influence of supine and stand-
ing positioning during RSA examinations. Most research showed that there
was no difference in the proximal femoral head penetration between standing
and supine radiographs (Digas et al. 2004, Bragdon et al. 2006b, Von
Schewelov et al. 2006, Callary et al. 2015). Some research indicated that there
were tiny differences between standing and supine groups, but the existence
did not affect the clinical results (Digas et al. 2004, Maruyama et al. 2014).

In this experiment, for wear measurement of 3Dwear, there were no significant


differences in most different pelvic orientations except pelvic lateral tilted left
5-degree position relative to the pelvic neutral position. Theoretically, RSA is
a 3D technique that is not affected by the orientations of the pelvis. However,
there are some disadvantages to EGS-RSA. When the pelvic orientation trans-
forms, the cup shape and position on the radiographic images will also switch.
On the other hand, due to the defect of EGS-RSA, the model of the cup cannot
be accurately matched accordingly.

53
Discussion

At present, for 2D preoperative planning software programs, there has been


no research about pelvic orientations and wear measurement either, which in-
volve more research on the measurement of inclination and anteversion of ac-
etabular cup (Bayraktar et al. 2017, Schwarz et al. 2020, Widmer 2020). The
position of the acetabular cup may influence the polyethylene wear during clin-
ical follow-up. However, there are no related reports on the factors affecting
the wear measurement using 2D preoperative planning software programs.

In this experiment, for wear measurement of 2D preoperative planning, there


was a significant difference in some different pelvic orientations, including pel-
vic tilted forward 5-degree position, pelvic tilted back 5-degree position, pelvic
rotated right 5-degree position, and pelvic lateral tilted right 5-degree position,
relative to the pelvic neutral position. In theory, mediCAD is a 2D technique
that is affected by the orientations of the pelvis potentially. Further, when the
orientation of the pelvis is different, the contours of the cup and femoral head
on the radiographic images will not be identified readily by the analyst, so the
centers of the cup and head cannot be accurately positioned, which will affect
the accuracy of wear measurement.

4.3 Strengths of the experiment


In the experiment, according to different pelvic orientations and different wear
groups, the accuracy and precision of the 2Dwear and 3Dwear were demon-
strated, respectively. The strengths of the experiment are based on the struc-
ture and innovation of this study, which will be elucidated in the following three
sections.

4.3.1 2Dwear measurement systems can meet clinical requirements


In clinical practice, standard a.p. radiographs of the pelvis are regularly used
for follow-up, which can be widely applied in any follow-up time points instead
of RSA. In the wear measurement process of analyzing the data with 2Dwear
by the preoperative planning program, in addition to referring to the size of the
calibration ball, the size of the acetabular cup and femoral head can also be
adopted to verify, which is beneficial to improve accuracy and precision of

54
Discussion

2Dwear. In this experiment of using 2Dwear, the precision and accuracy of wear
measurements at seven different pelvic positions were relatively high (P:
0.111-0.400 mm, A: 0.112-0.196 mm). On the other hand, the actual clinical
wear condition is within the setting range of the 2Dwear measurement systems.
In summary, clinical requirements can be met for the simplicity, universality,
practicability, and low cost of 2Dwear measurement systems.

4.3.2 Evaluating accurate wear measurement ranges by setting different


wear groups
The measurement protocol in this experiment referred to another study (Stilling
et al. 2012), which did not specifically analyze the differences among the three
wear groups of low, medium, and high. Most studies in the field of wear meas-
urement did not have focused on the classification of different wear groups.

The strength of setting different wear groups was to evaluate accurate wear
measurement ranges for two wear detection methods. By calculating the pre-
cision and accuracy of low wear, medium wear, and high wear groups individ-
ually, this study could provide insight into a clear comparison of the correlation
about wear values in different ranges between the two methods above.

In the experiment, there was more significant conformity between the two wear
detection methods in the medium wear group than the other groups, namely,
the medium wear group in 2Dwear was relatively accurate compared to 3Dwear.
In clinical practice, considering the wear rate of the material and referring to
different wear ranges, a more cost-effective measurement method can be de-
termined. The range of medium wear group was from 0.1 mm to 0.5 mm, which
meant that 2Dwear was available in initial wear measurements.

4.3.3 Simulating the problem of pelvic misalignment during clinical film-


ing by setting different pelvic orientations
In clinical practice, the change of patient positions, for example, tilt, lateral tilt,
or rotation of the pelvis, may affect the accuracy of wear measurement. Hith-
erto, there has been no research about wear measurement to simulate the
problem of pelvic misalignment during clinical filming.

55
Discussion

There were many strengths in setting different pelvic orientations in terms of


wear measurement. Firstly, this design was more in line with actual clinical
situations with various influencing factors. For instance, lumbar disorders could
cause hip joint rotation or lateral tilt. Secondly, this setting could reflect the
difference between 2D and 3D techniques in a superior way. Because in theory,
the 3D technique is relatively unaffected by position factors. Thirdly, the differ-
ent pelvic orientation settings combined with the wear value grouping design
could reveal the sensitivity of the low, medium, and high wear groups to the
influence of position factors more effectively. For example, the medium groups
from 2Dwear and the low groups from 3Dwear were relatively unaffected by
changes in different pelvic orientations. In other words, the low and high wear
groups in 2Dwear and the medium and high wear groups in 3Dwear were suscep-
tible to lower extremity positions. Among the pelvic images obtained at seven
different positions of the pelvis, the low wear group in 3Dwear and the medium-
wear group in 2Dwear might be better able to recognize the contours of the ac-
etabulum and femoral head than the other groups. Additionally, it seemed that
the high wear group was more sensitive to position factors. One of the possible
reasons was that the head was very close to the cup in this situation, and the
contour of the femoral head in the cup was not easily recognized in the high
wear group.

In conclusion, the setting involving different pelvic orientations in terms of wear


measurement could provide a stronger reference for clinical practice.

4.4 Limitations of the experiment


Inevitably, based on the design of the experiment, there were some limitations
to the study. The generalizability of the results was subject to certain limitations.
For example, it was not possible to evaluate all the materials. Recognizing the
factors affecting measurement wear results helps to understand the limitations,
which will be a fruitful area for further work.

56
Discussion

4.4.1 Factors affecting the precision and accuracy of wear measurement


As is well known, the factors that affect precision and accuracy are as follows:
(1) radiographic image quality, (2) contours and positions of cup and head, (3)
rater experience, (4) experimental device stability. Based on the principles, the
precision and accuracy of 3Dwear are higher than 2Dwear. 3Dwear uses algorithms
based on measurements of the contours of the femoral head, the cup, and the
opening circle of the cup (Börlin et al. 2006). Nevertheless, 2Dwear uses a digital
edge-detection technique.

Radiographic image quality was determined by machine performance and set


parameters, which were obtained after a series of preliminary experiments. A
study indicated that suboptimal radiographs affected the accuracy of wear
measurements and highlighted the importance of good quality radiographs for
wear measurements (Sychterz et al. 2001). The cup and head contours are
depended on the light transmission of prostheses, the positions of which are
based on wear protocol. The raters’ experience is essential as well, especially
when using RSA software to analyze images, which needs a particular learning
curve. The stability of the experimental device is a prerequisite to ensure that
the experiment can be repeated. For example, during the experiment of Part
D1 for the fifth time, H5 for 2Dwear was an outlier, but H5 for 3Dwear was within
the normal range. Moreover, the radiological images of RSA and plain AP were
obtained sequentially. This outlier might occur because the experimental de-
vice was loose somewhere during filming plain AP radiographic images.

4.4.2 Limitations
The basis of these two software data analyses is the visibility of the femoral
head contour in the cup, which limits the application of various materials in this
experiment. One of the limitations of this study was that only one material and
one size of cup and head were evaluated in this research.

In the wear protocol, in spite of there being three wear groups, only some pos-
sible clinical situations were simulated, and no simulations were performed on
clinically randomized conditions, which should be explored in future work.

57
Discussion

The experiment was repeated five times, which was evaluated in terms of intra-
observer variability except for interobserver variability. However, this has al-
ready been validated to be excellent by laboratory colleagues.

Seven different pelvic positions, including neutral, tilted ±5 deg, rotated ±5 deg,
lateral tilted ±5 deg, were simulated in our experiment. However, in clinical
practice, the pelvic position is more complicated, which is more a combination
of multiple directions rather than a single direction.

The direction of the wear vector was not addressed in this research, which was
inaccurate for the extent of wear. Wear patterns were multidirectional, most of
which occurred in the coronal plane. A study indicated that a single direction
of wear might underestimate the overall amount of true wear (Yamaguchi et al.
1997). Wear directions were not calculated because the position and direction
of the coordinate system were different in the two software settings, which
needed to be readjusted and reanalyzed. However, the wear measurement of
x, y, and z axes might provide an estimate of the corresponding direction of
wear.

4.5 Future work


Future work will focus on addressing limitations and improving the applicability
of experiments. One of the future work is to make corresponding improve-
ments to the above limitations. First of all, more materials and more sizes of
prostheses have to be evaluated in the future. Secondly, because the accurate
ranges of wear of 2Dwear and 3Dwear were obtained in this study, more reason-
able wear protocols can be redesigned. Thirdly, interobserver variability can
be assessed because the experience and habits of different raters can signifi-
cantly affect the measurement results. Fourthly, combined pelvic positions can
be incorporated. Fifthly, this influence of the change in the position of the femur
will be designed into future work. Sixthly, the experimental setup can be im-
proved to match the real anatomy more closely. Seventhly, more consideration
will be given to the direction of wear in the following studies.

On the other hand, the research will shift from phantom experiments to patients,
which requires more funding and more complicated procedures. If a 3D wear

58
Discussion

measurement is achieved by preoperative planning software, the lateral radi-


ograph or CT will be included, which can be compared with 3D RSA and reflect
the true wear in vivo further. In addition, different preoperative planning soft-
ware or different RSA software can also be compared, and joint wear meas-
urement can be extended to knee, shoulder, and ankle joints.

4.6 Conclusion
In summary, the accuracy and precision of two computerized wear measure-
ment programs have been analyzed according to different wear groups and
different pelvic orientations.

• For two methods, precision and accuracy are better in RSA, but 2Dwear
is an alternative to 3Dwear, especially in medium wear group, despite
being less accurate and precise.
• Most results of 3Dwear are not susceptible to lower extremity positions.
• The low and high wear groups in 2Dwear and the medium and high wear
groups in 3Dwear are susceptible to lower extremity positions.

59
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66
List of abbreviations

6 List of abbreviations
2D two dimensional

3D three dimensional

ABIM acetabular bone-implant-model

ANOVA Analysis of variance

AJRR American joint replacement registry

AP/a.p. anteroposterior

CAD model-based Roentgen stereophotogrammetric analysis using com-


RSA puter-aided design

c.c. craniocaudal

CMM coordinate measuring machine

CT computed tomography

DOF degree of freedom

EBRA Ein Bild Roentgen Analyse

FBIM femoral bone-implant-model

EGS-RSA Roentgen stereophotogrammetric analysis using ele-


mentary geometrical shape models

HXLPE highly cross-linked polyethylene

LOA limits of agreements

MBRSA Model-Based Radiostereometric Analysis

m.l. mediolateral

MRI magnetic resonance imaging

67
List of abbreviations

NSAIDs nonsteroidal anti-inflammatory drugs

OA osteoarthritis

PE polyethylene

PRP platelet-rich plasma

PTA the angle of pelvic tilt

RE model RSA Roentgen stereophotogrammetric analysis using re-


verse-engineered model

RKI Robert Koch Institute

ROMAN Roentgen Monographic Analysis Tool

RSA Roentgen Stereophotogrammetric Analysis

SD standard deviation

SPSS Statistical Package for the Social Sciences

THA total hip arthroplasty

UHMWPE ultrahigh molecular weight polyethylene

XLPE cross-linked polyethylene

XLPE_VE Vitamin E-blended, cross-linked polyethylene

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List of publications

7 List of publications
➢ Junzhe Wu, Yutong Hong, Zhuang Kang, Jing Xu, Raimund Forst, Frank
Seehaus. Assessment of interchangeable applicability of two wear
detection methods for total hip arthroplasty within an experimental
phantom-model setup. (in the process of submission)

➢ Effects of pelvic orientations on two wear detection methods for total hip
arthroplasty. 26th Congress of the European Society of Biomechanics
(Conference submission). In 2020

➢ Assessment of polyethylene wear in THA using Model-Based Roentgen


Stereophotogrammetric analysis - an experimental phantom-model setup.
German Congress of Orthopaedics and Traumatology (Conference
submission: The submitted abstract was published ). In 2020

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Appendix

8 Appendix

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Acknowledgements

9 Acknowledgements
This research project was completed under the guidance of my supervisor,
Prof. Raimund Forst. After the dissertation, I would like to express my gratitude
to him. He instructed me to do scientific research with the normative methods
and meticulous attitude, which benefited me a lot.

I also would like to thank my second supervisor, Dr. Frank Seehaus, for his
enthusiastic guidance and help in project design, experimental operation, and
revision of the thesis. When I encountered difficulties in the experiment, he
provided me with many useful suggestions.

On the other hand, I would like to show appreciation to my colleagues for their
help in the operation process of the experiment. Without them, I would not be
able to complete my experiment.

Additionally, I would like to thank the radiologists at the hospital of Malteser


Waldkrankenhaus St. Marien for their support in experimental filming.

Finally, I will give special thanks to my family for everything they did for me.

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