Trauma Plating Systems: Biomechanical, Material, Biological, and Clinical Aspects

implants.

Preface

Amirhossein Goharian

Trauma plating systems have been used for many years in the treatment of bone fractures. Over the years, these implants have developed significantly for better clinical outcomes. Yet, though manufactures and researchers have enhanced implantation and fixation features of trauma plating systems, these implants are still metallic based. On the other hand, demands for successful clinical outcomes are growing and patients expect good functionality of the fractured bones and affected joints that might not be fully achieved by metallic plating systems. It is, therefore, necessary that new concepts in view of biomechanical, material, biological, and clinical aspects be developed to enhance the effectiveness of plating fixation in treatment of bone fractures. Plenty of biomechanical and clinical published resources have been compared various plating fixation methods in treatment of bone fractures. However, the inception of new ideals for further development of plating systems have been less published; therefore, impressive breakthroughs and achievements have not been scientifically reported in recent decades. Likewise, reference books on the topic of plating system have not been published to review, discuss, and challenge the current development concepts of trauma plating systems.

These considerations all led and motivated the author to develop this book as an effective and constructive reference to explore, review, discuss, and challenge the development concepts of plating systems. This book covers general concepts in Section I that would be helpful for a better understanding of biomechanical, material, biological, and clinical aspects of trauma plating fixation. An introduction to trauma plating systems is provided in Section II to explore the fundamentals of trauma plating systems, principles of biomechanical evaluation methods, and biomechanics of plating fixation. In Section III, current metallic materials that are used to produce plating systems are reviewed and their advantages and disadvantages for use in plating fixation of bone fractures are discussed. Likewise, new promising biomaterials for use in plating systems are reviewed and their potential benefits to enhance the effectiveness of plating fixation are discussed. Section IV presents biomechanical-clinical aspects and challenges of plating fixation for various bone fractures. In fact, in this section, plating fixation of each bone fracture is evaluated individually based on the published biomechanical and clinical resources. The purpose was to point out those biomechanical and clinical challenges that are currently of concern among the orthopedic surgeons, biomechanical researchers, manufacturers, and institutes. Therefore, the expressed topics in each chapter of this section is different, which makes each chapter individually interesting for its associated audience. In the last section of book (Section V), the current development concepts are reviewed and then a novel development concept is comprehensively presented. According to this novel concept, a conceptual trauma plating system (advance healing fixation system (AHealFS)) is proposed to bring a science breakthrough in future development of these implants.

This book is strongly recommended to orthopedic surgeons who wish to enhance their biomechanical and material knowledge of plating fixation in treatment of bone fractures. Various clinical challenges of plating fixation have been biomechanically expressed and discussed to be useful for this audience. For product development researchers and engineers, consideration of all biomechanical, material, biological, and clinical aspects during development stage would be beneficial to promote the clinical benefits of trauma plating systems. This book will discuss these concepts in relationship to design features and benefits of plating systems. In fact, the engineering and scientific views of this audience to create design conceptions are effectively improved. In order to evaluate biomechanical strength of trauma plating systems, biomechanical researchers organize experimental tests and carry out finite element analysis. In this book, biomechanical evaluation methods are reviewed in depth and in general concepts, and furthermore, the effectiveness of utilized methods for various plating fixation of bone fractures are discussed individually. In this respect, the effective loading and boundary conditions are reviewed, discussed, or even proposed. In addition to evaluation methods, specific biomechanical concepts of plating fixation (e.g., plate and screw configuration) are outlined for this audience to be used in the arrangement of their testing and analysis setups. Other than specialist and experts, this book is a comprehensive resource for students in the disciplines of medicine, biomechanics, and biomaterials at various levels of education. In order to enhance the effectiveness of the book for this audience, contents were effectively expressed with supportive explanation of fundamental principles. Questions provided at the end of chapters, detailed tables of contents at the beginning of chapters, illustrations of main concepts as figures, summarizing of fundamental concept as tables, and expression of main phrases as a glossary at the end of the book enhance the effectiveness of reading and increase the accessibility of the content for effective, easy, and fast usage.

The author cordially welcomes readers from various disciplines to contribute their ideas, suggestions, and comments about the book contents for further improvement in future editions and to maintain the book as an effective reference book in terms of trauma plating systems considering biomechanical, material, biological, and clinical aspects.

November 2016

Section I

General Biomechanical, Clinical, and Biological Concepts

Outline

1 General Concepts

2 Mechanical Behavior of Cortical Bone

3 Mechanical Behavior of Trabecular Bone

1

General Concepts

Amirhossein Goharian

Abstract

Various aspects of biological, biomechanical, material, and clinical challenges are examined in an investigation of bone fracture fixation. Indeed, these factors are integral to the effective treatment of the bone fractures. Biologically, bone fracture is healed in couple of weeks or months and bone healing is progresses in main stages including hematoma, absorption of defective bone cells, soft callus formation, hard callus formation, and lamellar bone formation. In each stage, fracture fixation is crucial to maintain stability, and biomechanical aspects of fracture fixation play important role in fracture nonunion or malunion. In view of material concerns, the good biocompatibility of the implant material is the first challenge. Inherent mechanical, physical, and chemical characteristics of the material affect the long-term usability of the implant during fracture healing. Bioinertness, biodegradability, and bioactivity of the material in body fluid and in contact with bone tissue are also studied in development of the fracture fixation implants. Successful fracture healing is when the bone fragments are united anatomically with no misalignment. This would necessitate careful consideration of clinical aspects of fracture fixation. Preoperative study of the fracture, intraoperative reduction of bone fragments, proper implant selection, soft tissue preservation and treatment, and post-operative treatment plan are some clinical considerations that would significantly affect the extent of pain and functionality at the fracture site during healing period and after union of the fracture. All these various aspects of the fracture fixation are affected by each other; therefore, many biomechanical and clinical investigations are carried out to evaluate and clarify the effect of these factors on the efficacy of the bone fracture fixation. In this chapter, some general biological, biomechanical, material, and clinical terms utilized in bone plating fixation are reviewed and further details are extensively presented and discussed in the next chapters.

Keywords

Bone fracture fixation; general biological aspects; general biomechanical aspects; general material aspects; general clinical aspects

Chapter Outline

1.1 Biological Concepts 3

1.1.1 Bone Structure 3

1.1.2 Bone Remodeling 5

1.1.3 Bone Fractures 5

1.1.4 Fracture Healing 6

1.1.5 Osteointegration 7

1.1.6 Cell Proliferation 8

1.2 Biomechanical Concepts 8

1.2.1 Wolff’s Law 8

1.2.2 Biomechanics of Bone and Attached Soft Tissues 9

1.3 Material Concepts 10

1.3.1 Bioinert, Biodegradable, and Bioactive Materials 10

1.4 Clinical Concepts 11

1.4.1 Osteopenia and Osteoporosis Bones 11

1.4.2 Soft and Hard Tissues 12

1.4.3 Postoperative Clinical and Functional Outcomes 12

1.5 Remind and Learn 15

1.6 Think and Challenge 17

References 18

1.1 Biological Concepts

1.1.1 Bone Structure

Bone is a compact porous structure. Based on the bone type, the porosity of the bone structure is varied. Bones exist in two types: cortical and cancellous (trabecular) bone. The porosity in cortical bone is lower than cancellous bone. The strength of cortical bone is much higher than cancellous bone; therefore, the cortical bone is the load bearing portion of the bone. The cortical bone thickness alters based on the location of the bone. Fig. 1.1 shows the arrangement of cortical and cancellous bone in a proximal femur bone. Human bones are classified as lower extremity, upper extremity, mandible, skull, spine, clavicle, pelvic, scapula, etc. Lower extremity bones are femur, tibia, fibula, and foot bones. Cortical bone thickness in lower extremity and pelvic bones is higher than other bones as these bones are body-weight load bearing. Cancellous bone is found at the two ends of the long bones near to the joints. In small bones, such as hand and foot bones and at low thickness portions of the bones (e.g. ilium portion of the pelvic bone), cancellous bone is not only near to the joints. These bones have a high porous structure to enhance the flexibility of the bones at the joint and to absorb the excessive load and promote smooth movement of the bones at the joint. This type of bone structure provides effective load transferring between the long bones as it is a multidirectional loading structure [1]. In other words, due to the high-porosity structure of the cancellous bone, the load in various directions can be transferred effectively. Furthermore, based on the Wolff’s law, the cancellous (trabecular) bone architecture is dynamically altered to enhance the cancellous bone strength in alignment with principle stress [2]. Upper extremity bones are radius, ulna, hand, carpal, and humerus which form hand, forearm, and arm skeletal. The various portions of the long bone are displayed in Fig. 1.2.

Figure 1.1 Arrangement of cortical and cancellous bones in proximal femur bone.

Figure 1.2 Various portions of the long bone.

1.1.2 Bone Remodeling

Bone is one of the body tissues that is under constant reconstruction or regeneration. Three bone cells are involved in this process: osteocyte, osteoblast, and osteoclast. The osteoclasts are generated from the same precursors that produce white blood cells. Therefore, osteoclasts are inherently macrophage cells. They exist in the body fluid and where a defective bone is detected, they latch to the bone, and by secretion of some enzymes, absorb the injured bone areas, and provide the conditions for formation of new bone cell to replace with the reabsorbed defective bone. The osteoblast cells are available at the surface of bones as the lining cells. These lining osteoblast cells start to produce collagen fibers around themselves and then deposit mineral substance to be formed as osteocyte cells. The osteocyte cells are trapped in the bone matrix to be formed as lamellar bone. Generally, the osteoblast cell has some thin extensions that are sensitive to signals generated due to changes in mechanical, chemical, and electrical conditions surrounding the cell [3–5]. The stages of bone remodeling are summarized in Table 1.1.

Table 1.1

Bone Remodeling Stages

1.1.3 Bone Fractures

Bone is fractured due to the severe trauma injuries. When the bone is fractured, the fragments need to be anatomically repositioned for healing of the fracture gaps. The bone fracture is classified based on the location and severity of the fracture. The arbeitsgemeinschaft für osteosynthesefragen (AO) has classified the bone fractures in long bones according to two factors. First is the location of the fracture in the bone as distal, proximal, or shaft portion and second is based on the articular involvement in the fracture pattern which could be intraarticular (articular involvement), extraarticular (without articular involvement), or in combination. Trauma plating systems are one of the methods that are utilized to treat these trauma fractures. Based on the various types of fractures, the implants are designed and produced to fix the bone fractures in anatomical position.

1.1.4 Fracture Healing

In trauma injuries, the bone fracture needs to be healed or reunited. The biological process that results in the healing of the fracture is called fracture healing. For the successful and effective fracture healing, the bone fragments need to be anatomically repositioned to facilitate the formation of the new bone cells at the fracture site. For the fracture healing, blood supply is crucial. The healing of metaphysis bone is faster than diaphysis bone due to the higher blood supply at the metaphyseal bone. The bone healing is completed in five stages. First stage is hematoma, which is the formation of a mass of clotted blood at the fracture site. In this stage, the inflammation occurs and the defective bone cells are absorbed by osteoclast cells in the blood. In the next stage, the osteoblast cells start to make collagen fibers at the fracture site which is called soft callus. Then the collagen fibers are mineralized by calcium phosphate, bicarbonates, and other mineral constituents to make the callus harder which is called woven bone or hard callus. The woven bone is harder than the surrounding bone due to the high mineralization at the fracture site. The woven bone is gradually softened or restructured to be formed as lamellar bone. For further details Refs. [6–11] are recommended. The summary of fracture healing stages is given in Table 1.2.

Table 1.2

Fracture Healing Stages

1.1.5 Osteointegration

The integration of implant to the bone is known as the osteointegration ability of the implant. This term is used to explain to what extent the implant could be attached to the bone. The osteointegration is generally established when the implant material contains the similar bone mineral materials (e.g. calcium phosphate compositions). In trauma-plating systems, the osteointegration concept is discussed for the integration of the plate and screws to the bone. The plate is placed on the bone by purchasing the screws inside the bone (the application, functionality, and characteristics of trauma-plating systems are reviewed in Chapter 4: Trauma Plating Fixation). Therefore, the plate and screws are in contact with the bone and could integrate with the bone. Because the trauma-plating systems are considered as temporary implants and will be removed after fracture healing, the osteointegration of plate and screws would not be desired. However, the osteointegration of the screws to the bone immediate after fracture fixation is desired to enhance the stability of the bone-implant construct under physiological loading conditions. Osteointegration is an inherent characteristic of the materials that will be discussed in Section III for the alternative biomaterials for use in trauma-plating systems.

1.1.6 Cell Proliferation

Rapid multiplication of cells is called cell proliferation. This term is used to characterize the bioactivity of the implant in in-vitro tests. For instance, the osteoblast cells are subjected to the surface of the implant and then the proliferation of the cells is measured over the time to examine the bioactivity of the implant.

1.2 Biomechanical Concepts

1.2.1 Wolff’s Law

When the bone remodeling function is affected, the bone mineral density is altered. Basically, the bone mineral density is correlated with alteration of biomechanical stress transferred to the bone matrix. This mechanical-biological phenomenon was explored by Professor Wolff (1850–1914). He found the bone interacts itself according to the extent of transferred stress [12]. In fact, the bone becomes denser in high cyclic physiological loading conditions and less compact in low cyclic conditions. The interesting issue is that the bone mineral density is affected by cyclic or dynamic loading and not static loading. It means that the bone is adapted itself with transferred load in a gradual manner not with momentary or transient loading conditions. This is because the bone matrix tends to align with direction of the load and if the dynamic physiological loading condition is planned in constant regime, the bone could gradually strengthen itself effectively. This mechanical-biological effect would affect the cancellous or trabecular bone more than cortical bone. Due to higher porosity of the cancellous bone compared to cortical bone, the bone matrix would have higher chance to be realigned. Therefore regular exercise (as dynamic physiological loading conditions) could enhance the strength of the cancellous bone at two ends of the long bone and thus strengthen the joint (long bones are joined at their ends). Based on the correlation between the biological and mechanical factors in bone mineral density, the science of mechanobiology has become an interesting and effective research area in recent years for treatment of bone injures. Biological-mechanical interactions in bone tissue are briefly reviewed in Table 1.3.

Table 1.3

Biological-Mechanical Interactions in Bone Tissue

1.2.2 Biomechanics of Bone and Attached Soft Tissues

The biomechanics of the bone have been extensively investigated [13–18]. The researchers attempted to study the mechanical behavior and properties of the bone to find out the appropriate biomechanical treatment for bone injuries. Bone is a composite material with various mechanical properties along different axes. Bone is a viscoelastic material for which the elastic behavior is not linear. The tensile and compressive properties of the bone are different. Bone compressive strength is much higher than tensile strength. Mechanical behaviors of cortical and cancellous (trabecular) bones are reviewed in Chapter 2, Mechanical Behavior of Cortical Bone and Chapter 3, Mechanical Behavior of Trabecular Bone.

Generally, bones and attached soft tissues (tendons, muscles, and ligaments) bear the physiological loading conditions. Ligaments provide the tension bearing in joints to constrain the bones movement to a limited range of motion. Ligaments could be as the linkage between the bones like the interosseous membrane in the forearm that holds the radius and ulna bones together [19]. Soft tissues like tendons and ligaments are viscoelastic material with non-linear elasticity trend. Their behavior is like a tension element and is different with the spring mechanical pattern (the behavior of a compression-tension element, in finite element analysis software, is simulated by Ogden material type). The tension stress in tendons and ligaments creates bending moment to the bones during rotational motion at joints and this would significantly affect the stability of the bone fracture fixation.

1.2.2.1 Artificial Bone

Artificial bone (e.g. fourth generation composite bones (Sawbones)) have been developed for testing bone fracture fixation, with an attempt to keep the general mechanical properties of these bones as close to the human bone as possible. Gardner et al. [14] has investigated the compressive and bending strength of the fourth generation composite femur and tibia bones. They used linear quasistatic compressive loading. The strength of fourth generation composite bone is close to that of human bones. The artificial bone with similar mechanical properties with human bones could be used for biomechanical evaluation of bone fracture fixation. Such biomechanical studies will be reviewed and discussed in Section IV for each trauma plating system.

1.3 Material Concepts

1.3.1 Bioinert, Biodegradable, and Bioactive Materials

Currently developed metal implants for fixation of bone fractures are desired to be chemical resistant in ionized human body fluid. However, they might be affected by chemical, fretting, and galvanic corrosions. This would reduce the inertness of the implant. The extent of implant material inertness is shown its bioinert level in human body. Some materials are degraded in the human body environment. The degradation that is not harmful for the human body is known as biodegradation. The extent of this degradation specifies the degradation rate of the material or implant inside the body. Metals like iron and magnesium or ceramics like hydroxyapatite or bioglass are degraded in the human body with different rates. The biodegradation characteristic of the implant material is considered in development of the biodegradable implants. A material is bioactive when its composition is similar to bone minerals and could enhance the bone formation at the fracture site. Bone grafts are bioactive materials that can promote the fracture healing in osteoporosis bone or when the fracture gap is large. Bioactive material could enhance the osteoconductivity or osteoinductivity of the implants. Osteo-conductive implants absorb the bone cells at their surfaces and allow the osteoblast cells to be organized in a manner that can form as osteocyte cells and finally the formation of bone matrix around the osteoconductive material. Therefore, the osteoconductive materials are used for fabrication of porous-tissue engineered scaffolds when higher contact surface of the implant is desired which allows porous formation of bone tissue at the injured area. Osteoinductive implants induce the located osteoblast cells on the surface of the bone matrix to be active and generate collagen in their surroundings and then mineralize to osteocyte cells to strengthen the bone matrix. Table 1.4 shows the classification of the biomaterials within in vivo conditions.

Table 1.4

Classification of Implant Materials Based on Their Chemical Reaction in Human Body Fluid and in Contact With Bone Tissue

1.4 Clinical Concepts

1.4.1 Osteopenia and Osteoporosis Bones

Low mineral density of the bone, which is called osteopenia occurs when the function of bone cells mineralization is not appropriate. It might be due to the weak formation of collagen fibers which provide the essential fibrous scaffold for mineralization of the new bone cells. If the bone cells are not stimulated effectively by mechanical stress for a long time, low mineral density of the bone matrix could result and the performance of the osteoblast cells (as the bone formation cells) is reduced. This affects the process of bone remodeling at which the balance between application of the osteoclast cells to absorb the defective bone and osteoblast cells to generate new bone cells are affected. If this scenario is continued until the old age, the bone strength is significantly reduced which is called osteoporosis.

1.4.2 Soft and Hard Tissues

The body tissues which are studied in orthopedics are categorized based on their mechanical properties. Bone is considered as hard tissue which is mechanically stronger than soft tissues like muscles, tendons, and ligaments. The soft tissues have strength against tensile stress while the hard tissues bear all aspects of the mechanical stresses such as tensile, compressive, bending, torsion, and shear stress.

1.4.3 Postoperative Clinical and Functional Outcomes

The final goal of bone fracture fixation is to restore the natural function of the joints that have been affected by bone fractures (when the bone is fractured, function of the joints near to the fractured bone are affected). By fixation and treatment of the fracture site, full function of the affected joints is desired. The extent of joint function is studied and examined in clinical studies as the postoperative functional outcomes to evaluate the suitability of the surgery method, fixation method, and postoperative therapies in series of patients. In the plate-and-screw fixation method, restoring the bone fragments in anatomical position would make some minor and major irritation to the soft tissues. The plates are designed and manufactured to remove sharp edges and the surface is polished to minimize the risk of soft tissue irritation. However, the implant itself occupies space between the bones and soft tissues. Based on the patient’s bone size, the implant may interfere with soft tissue during the function or motion of the joint. In some rotational axes and angles, soft tissues might be irritated, which would cause patient discomfort and limitation of the joint function. In some cases the fixation stability might be lost and make irritation. This is the reason that clinical-biomechanical researchers routinely scrutinize or follow up the postoperative functional outcomes to study the clinical outcomes of various fracture fixation methods in different patients. The functional outcomes for various trauma plating systems are reviewed in Section IV for each system. Functional outcomes that are normally followed up in clinical studies are reviewed as follows and summarized in Table 1.5.

Table 1.5

Various Types of Clinical Outcomes

1.4.3.1 Range of Motion at Joint

The axes flexion-extension, internal external, pronation-supination, adduction-abduction are used to examine the extent of the joint movement in studies of postoperative functional outcomes. The ability of patient to move the intended joint is compared to the natural movement of the joint. During the fracture healing, if the joint movement is less than the full extent in natural condition, further treatments and exercises would be given to the patient to prevent the joint stiffness. After healing of the fracture, if the patient has difficulty to move the intended joint, the implant is normally removed. However, this issue is a very challenging matter that needs rigorous care from the surgeons to make an appropriate decision. In this regard, the patient’s body condition and bone mineral density should be considered during removing of the implant.

1.4.3.2 Daily, Work, and Special Activities

The joint function could be assessed in the activities that patient is doing daily, at work, or in other specific activities (e.g. play sport or musical instruments). Questionnaires are prepared to relate activities affecting the fracture site to quantify of comfort of the patient during performing daily or other specific activities.

1.4.3.3 Joint Strength

The joint strength is crucial to be scrutinized. Joint strength would actually relate to the healed bone strength which influences the ability of the patient to perform the activities with higher loading conditions. For instance, when the fracture has occurred in radius or ulna bones or even in carpal or hand bones, the grip strength of the hand is affected. To measure the hand strength, grip strength tester is used. The anatomical reduction of the bone fragment is crucial for effective performance of the muscle, tendons, and ligaments that are affected by bone fracture. Joint strengths test could examine the suitability of the soft tissue preservation during fixation and healing of the fracture.

1.4.3.4 Anatomical Positioning of the Bone Fragments

The anatomical position of the fracture fixation could be measured on radiographic, X-ray, or MRI scans. The bones are symmetrical over the sagittal plane (sagittal plane is a vertical plane that passes from anterior to posterior aspects of the body, dividing the body into right and left halves). If the injured bone is not in both sides, the fracture fixation measurements could be compared with the uninjured side. However, if both sides are injured, the measurement could be compared with the natural range in the patient’s similar population. The purpose of measuring fracture fixation anatomical positioning is to examine the fixation stability during the bone healing. The fracture fixation should be stable anatomically from operation to full fracture union for a good treatment of the bone