Biological Response to Orthopedic Implants and Biomaterials



Fig. 1.1
Total knee artroplasty



When you have a total knee replacement, the surgeon removes damaged cartilage and bone from the surface of the knee joint and replaces them with a metal and plastic. Because of the modularity of the cobalt-chromium femoral and titanium tibial components, crevice corrosion will be relevant. Because there is a polyethylene insert separating the cobalt-chromium component and the titanium plate, galvanic corrosion will be limited. Though wear through of the liner would present other concerns as well [31].


 





In engineering any substance that is used for manufacturing is called material. Biomaterials are natural or synthetic materials that treat, augment, or replace tissues and organs. Biomaterials are utilized to fulfill or support the task of living tissue in the human body which continuously or periodically comes into contact with body fluids. Biomaterials are different from other materials in the sense that they must have the ability to remain in contact with tissues from the human body without creating too much adverse or a hostile response. If a material is used in a human body, it has to be able to resist mechanical forces and chemical effects. Also this material is expected to exhibit osseointegration properties [14].

Men have used various materials to replace organs or parts of organs since the beginning of history. Glass for eyes, wood for teeth, gold in dentistry, and linen, horsehair, and cotton for suture were some examples of the uses of materials for various replacements. These materials were those used in everyday life. The evidence of their use as implants or prostheses were mainly discovered on human skeletons during the excavations of sites from different ancient civilizations: Egyptian, Roman, and Greek. Gold, as a metal, appears to be one of the earliest and main materials used by old civilizations, and, incredibly, it is still used today [5].

Musculoskeletal disorders are the principal cause of disability in all over the world and are responsible for chronic conditions. For a very long time, the use of materials mainly was more cosmetic than functional. Then surgeons and scientists were interested in the subject, and they developed functional materials for orthopedic and other surgeries. Because of their mechanical properties and resistance to corrosion, simple metals were chosen in the beginning, but incredible development of the plastics and ceramic sciences make possible the use of new materials, with diverse physicochemical and mechanical properties. The rate of orthopedic implant use is increasing, and this trend is expected to continue in the next decades due to aging population and improving medical care. Nowadays, the development of new biomaterials and their use in medicine has been an important domain. Despite major advances in orthopedic biomaterials and allergic and foreign body response, biomaterials-related complications such as implant loosening and infection are still restricting the use of biomaterials in daily practice [16].

The response of a material to deforming forces is characterized by its mechanical properties. Mechanical properties of biomaterials determine the deformation, failure behavior, and fracture of materials under the action of tensile, compressive, torsional, or combinations of these forces. As an example, mechanical properties would be very important for a joint replacement implant because it would be expected to withstand heavy loads generated during walking, and such loads can be very high. To determine the mechanical properties of a material, force versus deformation tests are conducted. In these tests, samples of a material are loaded at a constant rate, and both the deformation and the force required to cause that deformation are measured at various time points.

Biomaterials can be grouped under the four headings metallic, ceramic, polymeric, and composite materials. The biomaterials most commonly used in orthopedic surgery are metallic implants such as steel, cobalt-chrome, or titanium alloys, as they provide satisfactory mechanical performance. Screws, plates, and nails used for the treatment of fractures, hip and knee prostheses used in joint diseases, and spine implants are typical examples of metallic biomaterials used in orthopedic surgery. Most commonly used implantation devices in orthopedic surgery are made of metallic, ceramic, and polymeric biomaterials [14].


Metals


All materials are constituted of atoms that are bonded together by interactions. In metals, metallic atoms are closely packed in a crystal structure, and atoms are held together through a nondirectional strong metallic bond. Metals are group of materials with high corrosion resistance, biocompatibility, high wear resistance, and excellent mechanical properties such as good ductility and strength. Due to their crystal structure and strong metallic bonds with superior mechanical properties, they are used frequently as implant material. Metals have been preferred practically completely for load-bearing applications, such as joint arthroplasties and fracture fixation wires, pins, screws, and plates. Although pure metals can be used, metal alloys are preferable. Some characteristics, such as strength and corrosion resistance of metal implants, can be improved when used as a metal alloy by varying the composition or by using different manufacturing processes [7, 8].

Convenient mechanical properties, corrosion resistance, biocompatibility, and reasonable cost are the main considerations in preferring metal alloys for implant use. It is important to know the physical and chemical properties of the different metal alloys used in a surgery as well as their interaction with the host tissue of the human body, to be able to make knowledgeable decisions. Elastic modulus, yield stress, ultimate tensile stress, and fatigue stress are the most important characteristics of a metal implant defining its strength and stiffness. These properties of a metal can be seen from stress-strain curves. The strength characteristics of a metal can be influenced by the grain size, inclusion content, and surface porosity. A metal with a smaller grain size has a higher tensile and fatigue strength compared to the larger grain size. High surface porosity and too much inclusion content will weaken the metals [7, 8].

Extracellular fluid of human body contains various ions such as dissolved oxygen, chloride, and hydroxide. Therefore, the human body with a different ion concentration and pH changes in fluids is a highly corrosive environment for metals when used as implants. Corrosion is degradation of materials’ properties due to interactions with their environments, and corrosion of most metals is inevitable. While primarily associated with metallic materials, all material types are susceptible to degradation. Corrosion weakens the material; also corrosion products that enter into tissues can cause damage to cells. Three types of corrosion are common in implant materials: fatigue, galvanic, and crevice corrosion. Fatigue is the weakening of a material caused by repeatedly applied loads. It is the progressive and localized structural damage that occurs when a material is subjected to cyclic loading. If the loads are above a certain threshold, microscopic cracks will begin to form at the stress concentrators such as the surface and grain interfaces. Eventually a crack will reach a critical size, and the structure will fracture. Galvanic corrosion occurs when two different metals have physical or electrical contact with each other. An electric current is established between two metals that cause degradation. To avoid tragic galvanic corrosion, stainless steels should never be used with cobalt or titanium alloys. Crevice corrosion is a localized form of corrosion occurring in confined spaces, to which the fluid in contact with a metal becomes stagnant, resulting in a local oxygen depletion and decrease in pH. Stainless steel corrodes more readily than other alloys. Approaches available for controlling corrosion include the application of protective coatings to metal surfaces to act as a barrier or alteration of an alloy chemistry to make it more resistant to corrosion and the treatment of the surface of a metal to increase its resistance to corrosion. The chromium and molybdenum content of alloys produces a corrosion-resistant surface layer. Titanium alloys have an oxide passive film layer that provides their corrosion resistance. Nitric acid, by forming an oxide surface layer, is used to make the surface of the implant passive to corrosion [14].

The mechanical properties of the metal are important and should satisfy the requirements of the specific application in the body. For instance, when a metal is used to augment a bone, the elastic modulus of the metal should be ideally equivalent to that of the bone. If the elastic modulus of the metal is greater than that of bone, then the load experienced by the bone is reduced due to a phenomenon known as stress shielding. This can cause the bone to remodel to adjust to the lower load and eventually result in the loss of bone quality. Metals are passed through a series of processes to provide materials desired properties such as harder, softer, or durable.

Three material groups dominate biomedical metal implants: stainless steel, cobalt-chromium alloy, and titanium alloys. Other metals used in the biomedical industry include nitinol, tantalum, and magnesium. Nitinol, a nickel-titanium alloy, belongs to the class of shape memory alloys. At low temperature, these alloys can be plastically deformed but return back to their original predeformed shape when exposed to a high temperature. Tantalum (Ta) has been used for making biomedical implants and devices, either in its commercially pure (99.9 %) state or as an alloying element in titanium alloys. Tantalum is well known for its excellent corrosion resistance and biocompatibility because of a stable surface oxide layer. It has also been used as coatings on other metallic devices, such as 316 L stainless steel, to improve the substrate’s corrosion resistance and to enhance biocompatibility. The use of magnesium (Mg) for orthopedic applications dates back nearly half a century. Mg is well known for its light weight and biodegradability. The density, elastic modulus, yield strength, and fracture toughness of Mg are close to that of bone [19].


Stainless Steel


Stainless steel was successfully used as the first material in surgery. Stainless steel is essentially iron and carbon alloy which contain at least 10, 5 % chromium. Molybdenum and a small amount of manganese and silicon are added. The corrosion resistance of stainless steel is due to the formation of chromium oxide (Cr2O3) on its surface. The corrosion-resistant properties of stainless steel can be further improved by increasing the chromium content. These properties and other physical and mechanical properties can also be improved by the addition of several other alloying elements. For instance, addition of molybdenum increases pitting corrosion resistance, while the addition of nitrogen increases mechanical strength and pitting corrosion resistance.

Stainless steel is the common name for a number of different steels. Stainless steels with a smaller percentage of carbon, which are labeled 316 L, are used for orthopedic implants. The letter “L” represents low carbon content (<0.030 %). The low carbon content is highly preferred for excellent corrosion resistance. 316 L stainless steel consists of primarily iron (60–65 %), chromium (17–20 %), nickel (12–14 %), and smaller amounts of molybdenum, manganese, copper, carbon, nitrogen, phosphorous, silicon, and sulfur.

Stainless steel has been used for wide range of application due to easy availability, lower cost, excellent fabrication properties, accepted biocompatibility, and great strength. Despite composition modification, stainless steels are susceptible to corrosion; therefore, they are most appropriate for temporary implants such as plates, screws, hip nails, and intramedullary nails. The most common reason for corrosion of stainless steels is incorrect metal composition, which increases the chance that galvanic corrosion will occur. Molybdenum that is added in 316 L stainless steels hardens the passive layer and increases corrosion resistance. Another reason for corrosion is mismatch of implant components, especially when plates and screws are used. It is important to use implants manufactured by the same company with similar lots to avoid compositional differences of implant components [18].


Cobalt-Chrome Alloys


The cobalt-based alloys are characterized by high fatigue and wear resistance and high tensile strength levels. These properties make them desirable for load-bearing and articulating surface applications, appropriate for applications requiring long time use and ability to resist fracture. Cobalt-chromium alloys can be separated into two types: first one which has been used for making artificial joints consists of Cr (27–30 %), Mo (5–7 %), and Ni (2.5 %) and the second one which has been used for making the stems of prostheses contains Cr (19–21 %), Ni (33–37 %), and Mo (9–11 %). Cobalt-based alloys are highly resistant to corrosion due to spontaneous formation of passive oxide layer within the human body. Molybdenum is added to produce finer grains which result in higher strength. Elastic modulus of the alloy containing cobalt is greater than that of stainless steel. The corrosion products of Co-Cr-Mo are more toxic than those of stainless steel [14].


Titanium Alloys


Titanium alloys due to its outstanding characteristics such as lightweight, high strength, good resistance to corrosion, improved biocompatibility, and better elastic modulus are a suitable choice of metal for implantation. Although it is a lightweight material, titanium provides excellent mechanical and chemical properties comparable to stainless steel and cobalt-chromium alloy. Long-term use of titanium alloys has raised some concerns because of releasing aluminum and vanadium ions which might be related to Alzheimer disease and neuropathy.

The mechanical properties of materials are very important when using load-bearing orthopedic implants. Some mechanical properties of metallic biomaterials are listed in Table 1.1. The mechanical properties of an implant depend not only on the type of metal used but also on the processes used to manufacture the material and implant. The elastic moduli of the most metals listed in Table 1.2 are many times greater than that of natural bone. Titanium alloys have a surface passive oxide layer which is mainly responsible for its extremely good corrosion resistance and biocompatibility. Titanium alloy plates are gaining popularity because of these material characteristics [15].


Table 1.1
Mechanical properties of tissues [4]







































 
Modulus (GPa)

Tensile strength (MPa)

Cortical bone (longitudinal direction)

17.7

133

Cortical bone (transverse direction)

12.8

52

Cancellous bone

0.4

7.4

Articular cartilage

0.010

27.5

Fibrocartilage

0.159

10.4

Ligament

0.303

29.5

Tendon

0.401

46.5



Table 1.2
Mechanical properties of metallic biomaterials [4]











Material
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Jul 3, 2016 | Posted by in MUSCULOSKELETAL MEDICINE | Comments Off on Biological Response to Orthopedic Implants and Biomaterials

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