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Textbook Biomaterials in Clinical Practice Advances in Clinical Research and Medical Devices 1St Edition Fatima Zivic Et Al Eds Ebook All Chapter PDF
Textbook Biomaterials in Clinical Practice Advances in Clinical Research and Medical Devices 1St Edition Fatima Zivic Et Al Eds Ebook All Chapter PDF
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Fatima Zivic · Saverio Affatato
Miroslav Trajanovic · Matthias Schnabelrauch
Nenad Grujovic · Kwang Leong Choy Editors
Biomaterials
in Clinical
Practice
Advances in Clinical Research and
Medical Devices
Biomaterials in Clinical Practice
Fatima Zivic Saverio Affatato
•
Editors
Biomaterials in Clinical
Practice
Advances in Clinical Research and
Medical Devices
123
Editors
Fatima Zivic Matthias Schnabelrauch
Faculty of Engineering Biomaterials Department
University of Kragujevac INNOVENT e.V.
Kragujevac Jena
Serbia Germany
This book is the result of contributions from senior researchers active in the various
areas of biomaterials pertaining to the current state of development in medical
implants and devices. Academic researchers, as well as clinicians with extensive
experience in both theoretical and practical aspects, have presented insights into the
specific areas of biomaterial characterisation, development and applications. Novel
biomaterials applied for medical implants and devices have boosted significant
advancements not only in regenerative medicine and medical diagnostics, but also
in many other health-related fields. Immense research efforts and numerous pending
patents in the world all indicate the largest research field ever, if quantified by
the number of people involved in the development. Beside nanotechnologies,
biomaterial market represents one of the major driving forces in research today,
comprising wide engaged resources. Medical implants that can fully replace organs,
or tissues, or repair them, without detrimental side effects are long investigated,
with ultimate goal of ideal biomaterial design. This field is especially important
considering the fact that human population grows older.
Some of the largest investments ever have been recorded in case of several
biotech start-ups, promising cures for incurable diseases, and significant new
solutions in regenerative medicine and tissue engineering. Report on global market
trends (http://www.marketsandmarkets.com) forecasts that biomaterial market will
grow to USD 149.17 Billion by 2021 from USD 70.90 Billion in 2016, at a CAGR
of 16.0% from 2016 to 2021. Biomaterial market is segmented by the material types
(e.g. metals, ceramic, polymer, natural materials and composites) and according to
the applications (e.g. orthopaedic, dental, cardiovascular, plastic surgery, wound
healing, neurology, tissue engineering, ophthalmology). However, even with the
undeniable proven results of different implantable devices (hip and knee prosthesis,
spinal prosthetics, stenting and many other), there are still many challenges and
restraints in their use. Each type of biomaterial exhibits some drawbacks, thus
demanding more research efforts towards developing fully human compatible
materials. Along with the growing field of nanotechnology, with many
interconnections, the field of biomaterials development has drawn attention of
governments, funding agencies, healthcare charities and investment bodies. This is
v
vi Preface
scope of available instruments and fully reliable methods for in vivo diagnostics.
In particular, high resolution in situ microscopy is expected to provide better
diagnostics, and these instruments and methods belong to a cutting-edge research
with extremely high cost of devices that recently have started to appear.
We believe that this book will provide young researchers and professionals with
valuable insights into the state of the art in development of biomaterials in clinical
practice today, from aspects of different expertise: medical, engineering, physics,
chemistry and material science, to motivate them to pursue further research and
practical applications. The book will provide clinicians with the review of existing
solutions in specific medical areas, also from other approach beside medical, thus
enabling them more profound selection of implantable solutions in clinical cases.
This work is the result of joint efforts of different academic, and research
institutions participating in the large international project, WIMB Tempus,
543898-TEMPUS-1-2013-1-ES-TEMPUS-JPHES, “Development of Sustainable
Interrelations between Education, Research and Innovation at WBC Universities in
Nanotechnologies and Advanced Materials where Innovation Means Business”,
co-funded by the Tempus Programme of the European Union.
ix
x Contents
xiii
xiv About the Editors
Abstract The hip joint is one of the largest joints in the body and is a major
weight-bearing joint. The function of the hip is to withstand body weight during
standing and walking; during single leg stance the hip joint must carry a load three
times greater the body weight. However, Joint degeneration is the final phase of the
joint cartilage destruction, leading to severe pain, loss of mobility, and sometimes
even angular deformity of the limbs. The primary reasons for a large number of
total hip replacements are osteoarthritis and osteoporosis of the femoral neck, which
often leads to hip fractures. One of the most successful techniques to restore
function of a degenerated joint is the total joint replacement. In this surgical pro-
cedure, diseased cartilage and parts of the bone are removed and replaced with an
appropriate joint prosthesis. Several types of materials and techniques have been
developed for this purpose: glass, polymer, metal alloy, ceramics, etc. Earliest
prosthesis designs and biomaterials that have been developed to treat osteoarthritic
hip degenerated joint surfaces were for the most part empirical and unsuccessful.
Joint replacement heralded a revolution after the materials and replacement pro-
cedures developed by Sir John Charnley. A modern total hip prosthesis consists of a
S. Affatato (&)
Medical Technology Laboratory, Rizzoli Orthopaedic Institute,
Via di Barbiano, 1/10, 40136 Bologna, Italy
e-mail: affatato@tecno.ior.it
K. Colic I. Hut
Innovation Centre of Faculty of Mechanical Engineering,
University of Belgrade, Belgrade, Serbia
e-mail: kbojic@mas.bg.ac.rs
D. Mirjanić
Academy of Sciences and Arts of Republic of Srpska, Banja Luka,
Bosnia and Herzegovina
S. Pelemiš
Faculty of Technology, UES, Zvornik, Bosnia and Herzegovina
A. Mitrovic
Biomedical Engineering Department, Faculty of Mechanical Engineering,
University of Belgrade, Belgrade, Serbia
Keywords Biomaterials Hip prosthesis Femur Polymer Ceramics Metallic
biomaterials
1 Introduction
The hip is a ball-and-socket joint realized by the acetabulum (the socket) and the
head of the femur (the ball). In Fig. 1 is showed this kind of articulation.
The hip joint is one of the largest joints in the body and is a major
weight-bearing joint. Weight bearing stresses on the hip during walking can be 5
times a person’s body weight (Dunn 1987). A healthy hip can support our weight
and allow us to move without pain. Changes in the hip from disease or injury will
significantly affect the gait and place abnormal stress on joints above and below the
hip. The hip bears the body’s weight during standing and walking and it have three
different bones (Ilium, ischium, and pubis) that contribute to the formation of the
coxal bone during skeletal growth. Moreover, this articulation allows large
movements, i.e. flexion/extension (in the sagittal plane), abduction/adduction (in
the frontal plane), and internal/external rotation.
The ilium is formed by two main parts: the body and the ala (Marieb and Hoehn
2007). The body of the ilium forms the upper part of the acetabulum while the ala is
smooth and it is covered by the iliopsoas muscle whereas the external surface gives
attachment to the gluteal muscles. Along its upper margin there is a longitudinal
crest which has an inner and an outer lip. The ischium forms the lower and posterior
part of the coxal bone. The first visible structure in the back of the ischium is the
ischial spine. Under the ischial spine the lesser sciatic notch precedes the ischial
tuberosity, which is a large and strong apophysis where the posterior muscles of the
thigh have origin. The ischium is connected to the pubis through a lower ramus that
starts from the ischial tuberosity and continues upward and medially. The pubis is
connected to the ischium through the lower and upper ramus. These rami determine
a hole called obturator foramen.
The acetabulum is an hemispheric cavity located at the center of the outer
surface of the coxal bone. It is directed downward, lateral ward and forward
(Vandenbussche et al. 2008). Its inner surface is coated by a cartilage layer except
its central part which is the site of origin of the ligamentum teres. The lower part of
the outer rim of the cavity is interrupted by the acetabular notch. The glenoid
Short History of Biomaterials Used in Hip Arthroplasty … 3
without pain and with a very low friction even in the presence of great pressures
(Gray and Bannister 1995).
From a medical standpoint, the hip is one of the most significant joints in the body.
As the hip enables articulation between the femur and the acetabulum of the pelvis,
the ability to walk depends on the healthy and painless hip. The hip is troubled by
two types of ailments, both very common in the elderly. Osteoarthritis is the pri-
mary reason for a large number of total hip replacements each year, and the
osteoporosis of the femoral neck leads to several thousand hip fractures a year,
nearly all of them requiring surgical treatment, either with implants, or metallic
fixation parts (Katz 2006; Bannister 2003; Coomber et al. 2016). It is of most
importance to understand forces acting on the hip joint during daily activities,
especially during gait cycle, and the mechanics of the hip joint in order to solve the
hip implant design problems. (Abujaber et al. 2015; Simpson et al. 2010).
Several million people fracture their hips each year, risk for women being 40%,
and 13% for men (Dulić et al. 2003). Osteoporosis is the decrease of the bone mass,
and fracture risk factors for osteoporosis patients of both sexes are clinically
asymptotic until fracture. A large number of factors influence the risk of hip frac-
ture, some of them being sex, age, stage of osteoporosis, body mass and height
(Bottai et al. 2015; Nasiri and Luo 2016; Starup-Linde et al. 2017). Hip fracture
results from acting of non-physiological forces, the main cause of the fracture being
the nonelastic impact of the body on the ground. Different types and grades of hip
fracture are a result of complex deformations arising from direct impact of the hip
joint on the ground. Due to varied stress distribution inside the femur, a large
number of different hip fracture types are possible.
The main classification of hip joint fractures is: intracapsular (occurring inside
the joint capsule) and extracapsular (occurring outside the joint capsule). There are
various types of hip fractures, and the fracture of the neck of the femur is the most
common one, considered an intracapsular fracture.
The goals of the treatment of fracture are: swift healing, re-establishing joint
function and preservation of aesthetic qualities. Generally speaking, fracture
treatments can be classified as nonsurgical and surgical. The choices of the surgical
treatment is established on the basis of each individual patient’s clinical record, as
each type and place of the fracture produce a unique problem that requires specific
methods of treatment. If there is a possibility to retain the femoral head, fracture
fixation method is chosen as the method of treatment in dislocated and
non-dislocated femoral neck fractures (Boelch et al. 2017). This method of fixation
uses screws for fastening the fracture after repositioning, and is indicated for use in
patients with good bone density.
6 S. Affatato et al.
As for the intertrochanteric fractures, intramedullary nails are used as well. All
internal fixation devices must conform to the defined biomaterial standards, and
therefore stainless steel, cobalt-chrome alloys and titanium alloys are used.
Partial or total arthroplasty is chosen as the surgical method of treatment when it
is necessary to remove the head and part of the femoral neck (Gard et al. 2000).
Total hip joint prosthesis is used when the clinical record contains osteoarthrosis,
rheumatoid arthritis, or several other pathological conditions. Total hip arthroplasty
(THA) is a widely used strategy to restore normal hip join function, impaired
through fracture or ailment (Chimento and Sculco 2001).
Joint degeneration is the final phase of the joint cartilage destruction, leading to
severe pain, loss of mobility, and sometimes even angular deformity of the limbs.
One of the most successful techniques to restore function of a degenerated joint is
the total joint replacement. The main surgical procedure is to remove diseased
cartilage and parts of the bone and insert an appropriate hip prosthesis.
Total hip replacement is an effective treatment for severe osteoarthritis (when
this degenerative joint disease is mechanically initiated, which is often the case, it is
more correctly termed osteoarthrosis), invalidating effects of rheumatoid arthritis,
congenital deformations and some types of post-traumatic conditions (Learmonth
et al. 2007). It should be noted that one of the most common indication for total
joint replacement is osteoarthritis and accounts for approximately three quarters of
the total (Katz 2006).
Patients with much degenerated joints greatly benefit from total hip arthroplasty,
for in this way they are swiftly rid of the pain, and have their normal movement
functions restored. However, total joint replacement surgical procedures have their
drawbacks. Total hip arthroplasty is usually indicated in patients over 50 years of
age suffering from advanced osteoarthritis, except in patients with rheumatoid
arthritis, which is sometimes indicated in younger persons with rapid progressive
joint destruction. The cause of this indication limitation is the longevity of the
prostheses. A multicentre study of the longevity of the total joint prostheses has
shown that the greatest probability for implant failure due to fracture or wear occurs
around 5 to 10 years after the procedure (Archibeck et al. 2006; Schmolders et al.
2017). The designs and materials are constantly improved, but the available pros-
theses still have the problem with longevity (Sedmak et al. 2010).
The number of cycles of an individual prosthesis is naturally directly linked to
the level of the activity of the patient. Therefore, implant failure is more common in
younger, than in older patients.
Many efforts have been made to find the suitable material for hip joint: glass, polymer,
metal alloy, ceramics, etc. First attempts of hip surgery found place in England
between 1750 and 1820, in the effort to heal arthritis cases (Gomez and Morcuende
2005). In 1840 the idea was to think that hip joint could be replaced artificially
Short History of Biomaterials Used in Hip Arthroplasty … 7
In the 1960, Dr. San Baw (Baw 1970), performed the first hip replacement on an
83 years old woman, using ivory like prosthetic material. Between the 60’s and the
80’s he performed over 300 ivory hip replacements describing an 88% success rate.
Several approaches were made in this orthopaedic filed but was a British surgeon
(Sir John Charnley) that pioneered the modern concept of total hip arthroplasty.
Charnely performed its first hip implant using a combination of a femoral head (in
stainless) steel coupled with acetabular cup (in Teflon -PTFE). After this failure,
Charnley used, as acetabular cup, a new polymer: the so-called
ultra-high-molecular weight- polyethylene (UHMWPE). These studies focused on
the lubrication phenomena and they led to the concept of Low Friction Arthroplasty
(LFA) in which the low friction depends mostly on the friction coefficient of the
facing materials and only marginally on the fluid presence (McKee 1982). In Fig. 4
is showed a typical hip prosthesis.
Several variations contributed to the original design. In the 70’s
Cobalt-Chromium-Molybdenum (C-Cr-Mo) alloys were introduced in the low
decreasing of the average age of the patients undergoing first implant and limited
lifetime of the prosthetic components are factors that will raise the number of
people in need of this medical intervention in the next future.
The hip joint is a perfect example of congruous joint, designed for standing and
walking, that allows wide variety and range of motions (Morlock et al. 2001). The
particular simmetry of this joint allows for rotation about a fixed axis; infact nearly
all motion between femoral head and acetabulum is rotational. The hip joint, as
previously discussed, is composed by the femoral head and the three bones forming
the pelvis: ilium, ischium and pubis. The femoral head, covered by cartilage, fits the
acetabulum and the joint is kept lubricated with the synovial liquid (Sink et al.
2011). The human hip joint can be affected by different pathologies such as
osteoarthritis, avascular necrosis, tumour, rheumatoid arthritis, femoral neck frac-
ture, road accidents. In a THA intervention, the damaged bone and the cartilage are
removed and replaced with the prosthetic components in order to restore joint
functionality. The femoral head is most of times completely removed and replaced,
or trimmed and covered by a metallic cap (resurfacing approach).
Artificial hip joints have evolved from their pioneering design, but, unfortu-
nately, wear of their components remain a problem.
Some of the earliest prosthesis designs have been developed to treat degenerated
joint surfaces in the case of an osteoarthritic hip. These prostheses were made from
various materials, and their choice was, for the most part, empirical. There were no
studies to ascertain if the material is suitable to be used in a design. Therefore, some
of the implants were moderately successful, whereas other failed catastrophically.
Earliest attempts to return mobility to painful and deformed hip joints date to
early 1820s and are centred on simply removing the affected femoral and acetabular
bones. From 1830 to 1880 this evolved to attempts, which were quite unsuccessful,
to regain joint mobility using interposition membranes between the femoral head
and acetabulum, using materials such as wooden blocks and animal soft tissues
(Gomez and Morcuende 2005). It was not until 1923 that Marius Smith-Petersen
developed “mould”arthroplasty, which is considered the onset of modern total hip
replacement (Smith-Petersen 1948; Hernigou 2014). The implant was made from
glass in the shape of a hollow hemisphere, which was attached onto the femoral
head, creating a new sliding surface. Although biocompatible, glass could not
endure stresses during the gait cycle and failed.
The first corrosion-resistant metal that had sufficient biocompatibility, and
became available in 1939, was a cobalt-based alloy named Vitallium, used by
Venable, Stuck and Beach (Ratner et al. 2004). Although this new material was
successful, being very hard and corrosion-resistant, the procedure of replacing the
joint surface was not adequate.
Despite the excellent designs of these early long stem prostheses, they were
primarily successful when they were used to replace the afflicted femoral heads, and
did not perform well when acetabular reaming was necessary. Therefore, this dis-
ability started the development of total hip arthroplasty.
The first total hip arthroplasty is attributed to Philip Wiles in 1938, when he used
a stainless steel ball attached to the femur and a stainless steel acetabular lining
Short History of Biomaterials Used in Hip Arthroplasty … 11
attached by screws (Wiles 1958). The results of this design were disappointing, for
these early stainless steels had low corrosion resistance in vivo and large stress
concentrations on short stem prostheses.
One of the primary questions addressed by early researchers was fixation of the
prosthesis component to the bone. Although Moore and Thompson’s prosthesis
showed excellent early results, it was not altogether successful, for cases of implant
loosening were reported due to wear. Introducing an opening on the implant surface
to encourage bone ingrowth did not result in sufficient biological fixation, which
would stop the micro-movement of the prosthesis. To address this problem, John
Charnley during the 1960s introduced poly(methyl-methacrylate) (PMMA), a
cold-curing bone cement, which facilitated a safe fixation of prosthesis components
(Charnley 1970).
Joint replacement heralded a revolution in treating diseased or damaged joints,
bringing pain relief and restoring function. The materials and replacement proce-
dures developed by Charnley were later used to treat other joints, such as knees,
elbows and shoulders.
One of the foremost problems in the total replacement of hip and other joints is
implant fixation. This problem arises because the implant is fixated onto cancellous
bone, which is significantly weaker than cortical bone, and there could be insuffi-
cient trabeculae to support loads. In addition, stress concentration on the points of
contact, such as the posteromedial region, and the lateral end of the femoral stem,
causes resorption of already weakened bone.
In addition to providing the initial fastening of implant to bone, cement is used
as a shock absorber as well, by virtue of being a highly elastic biomaterial. Bone
cement also facilitates a more uniform distribution of load across the greater sur-
face, and reduces stress concentration on the bone, which arises due to the presence
of the prosthesis. This stress shielding effect causes bone resorption in the proximal
region due to the reduced stress, which leads to implant loosening, or stem failure.
According to implant placement and manufacturing procedures, currently there
are two types of prostheses: single-part (monolithic) or block prostheses and
modular (multi-part – two or more) prostheses. Modular components are assembled
during the surgical procedure, and enable implant adjustment during surgery, and
subsequent revisions. Block hip prosthesis are shown on Fig. 5, whereas Fig. 6
shows femoral parts of various modular prostheses.
In general, total hip prosthesis consists of a femoral and acetabular component, with
the femoral base divided into the head, neck and stem. In total hip prosthesis, the
femoral head is most commonly made of cobalt-chrome alloy, alumina or zirco-
nium, whereas the stem component, formerly made from 316L stainless steel, is
now usually made of Ti- alloy or Co-Cr-based alloy. Sliding surfaces are often
12 S. Affatato et al.
Fig. 5 Examples of
monolithic prostheses
It should be noted that the metallic sockets are in clinical use approximately
45 years, and alumina sockets around 35 years of clinical use so far. Figure 8
shows various types of sockets of differing diameters, made from metal or ceramics.
Polymers in orthopaedics are most commonly used for articulating sliding sur-
faces in joint replacement, and as a cement material between bone and implant.
Polymers used for articulating surfaces must have a low coefficient of friction and
low rate of wear in contact with other surface, which is usually made from metal.
Polymers used for fixation, as a structural connection between implant compo-
nent and bone tissue, must have appropriate mechanical characteristics, must be
able to be cast into a specific shape, and be cured in vivo.
One of the most commonly used polymers presently used in orthopaedics is a
highly cross-linked UHMWPE, typically used in total hip arthroplasty as a sliding
surface designed to enable sliding articulation with low friction. Polyethylene is
commercially available in three types: low density, high density, and UHMWPE.
Denser packing of linear chains in UHMWPE achieves better mechanical charac-
teristics necessary for application in orthopaedics, although ductility and strength
are reduced. In total hip arthroplasty, an acetabular cap made from UHMWPE
typically articulates against a Co-Cr alloy femoral head (Buford and Goswami
2004).
In recent years ceramics and glass-ceramics are gaining in importance in man-
ufacturing implants. Although they have been in use for over 25 years in Europe,
only in 2003 has the FDA approved the first hip prosthesis to be made with sliding
surface of type ceramic-ceramic, and be used in hip replacement procedures in the
USA. The primary reason for introducing this alternative sliding surface is the
superior wear resistance of ceramics in comparison to metal-metal, or
metal-polymer sliding surfaces (Wang and Essner 2001). These and other improved
characteristics, as the resistance to further oxidation (resulting in inertness inside the
body), high strength and low friction, require using the ceramic materials with
controlled, small and uniform grain size (Slonaker and Goswami 2004). Small grain
size and full density are important, for they are two basic parameters controlling the
mechanical characteristics of ceramics. Cavities in the ceramic body increase stress
16 S. Affatato et al.