Fracture-fixation by bone-plate is intended to provide immobilization at the fracture site and reduce the fracture gap, thus allowing primary bone-healing or healing by endosteal callus formation (for micro-movement in order of 500 microns). The role of bone-plate and screws is to hold the fractured bone segments in position, without allowing tensile stresses at the fractured interface but rather have some critical compressive stress induced in it so as to accelerate healing. The complications associated with plate fixation are loosening of screws under loading, local effects on vascularity of the cortex beneath the plate (blocking normal blood flow), and (from a biomechanics viewpoint) excessive shielding of stresses from the bone [1–3].
The biomechanics factors, governing the healing efficiency in fractured bone treated by plate and screws, are: (1) the degree of bone contact developed at the fracture interface, (2) stability provided to the fractured bone in terms of reduced movement at the fracture interface, and (3) necessary and sufficient stress-shielding of the bone at fracture interface as well as away from it. Hitherto, conventional high-stiffness stainless-steel (SS) have been employed for long-bone fracture-fixation. However, the big difference in modulus between the plate and bone as well as the compressive stresses occurring between the plate and the bone (due to over-tightening of screws) disturb the vascularity of the bone underneath the plate, causes bone resorbtion underneath the plate and reduction in its strength as a long term effect.
In recent years, there has been considerable awareness and discussion on the need for using less-stiff plates to improve fracture healing and prevent bone weakening due to stress-shielding [2–10]. It is not entirely correct to say that bone-plates with high stiffness (or Young's modulus 'E') cause excessive stress-shielding, because stiffness is characterized by the product E and moment of inertia of the plate cross-section; hence the plate geometry also has a bearing on the stiffness as thereby on the stress-shielding of the bone. However, for a uniform plate geometry, plates with a lower E will offer less stress shielding than the plates with higher Young's modulus .
Materials involved in bone-plate design
The biocompatible materials used for bone plates are: stainless steel (SS), cobalt base alloys, bioceramics, titanium alloys, pure titanium, composite materials, and polymers (non-resorbable and bioresorbable). Each of the above materials can broadly be categorized as (i) bioinert (ii) porous, (iii) bioactive, and (iv) bioresorbale . In general, bioinert material is selected for bone-plates because bioactive material gets bonded with the bone (along with the soft tissues) and causes problems if plate removal or corrective surgery is required.
The bioceramic materials which are bioinert (like Al2O3, ZrO2), possess Young's modulus (E) in the range of 400 ± 20 GPa, in contrast to that of hydroxyapatite. While the properties of ceramics (such as high hardness, chemical inertness, oxidation resistance, high strength, high melting points and low fracture toughness) are suited to the requirement for the bone-plate, its brittleness and high 'E' result in stress-shielding of the bone, thus limiting its use for bone-plates .
Metallic alloys like Cobalt-base alloys (e.g CoCrW, CoCrMo) have 'E' of about 250 ± 10 GPa along with wear, corrosion and heat resistances. However, they are not suitable for usage, owing to their poor fabricability and high cost . Stainless steel (e.g 316L) is one of the most preferred biomaterials for bone-plates, because of its mechanical properties ('E = 200 ± 20 GPa', ductility etc), corrosion resistance, bioinert and cost-effectiveness in comparison with other biocompatible metals . Titanium alloys (e.g Ti-6Al-7Nb, Ti-6Al-4V), with E of 110 ± 10 GPa, are especially preferred for bone screws, because of their increased corrosion resistance and improved ductility. However, although titanium alloys offer improved strength (with less ductility) compared to pure titanium, they are not preferred for plate implants because of difficulty in their contouring (as required for pelvic and mandibular plates). Titanium alloys are however preferred for intramedullary rods, spinal clamps, self-drilling bone screws and other implants, because of their high strength and low 'E' .
Pure Titanium metal is also one of the most widely chosen materials for the bone-plates, because of its excellent biocompatibility and corrosion resistance. The ductility of titanium is less compared to SS, because of its hexagonal crystal structure. This makes contouring of titanium plates difficult, compared to stainless steel plates. Titanium plates also offer less stress-shielding to bone (for the same geometries) after healing, because its 'E' is 68 GPa compared to 200 GPa of SS . However, they are not as amenable to contouring as SS plates.
Composite materials (e.g. Carbon Fiber Reinforced Polymers, CFRP) which consist of a polymer matrix and fibre, which are combined to achieve the requisite high strength and adequate 'E' value. The polymer matrix materials can be broadly classified as resorbable (e.g. polysorb, biosyn) and nonresorbable (such as PEEK, ultrahigh molecular weight polyethylene or UHMWPE). Polymers per se do not have the strength and stiffness required for bone-plates; hence polymers reinforced by fibers are employed for the bone-plate application or used as scaffolds in the preparation of bone grafts . Composite materials used for bone-plates mainly consist of a thermoplastic polymer matrix (such as polyetheretherketone or PEEK, polymethylmethacrytale or PMMA etc.) and fibres such as glass or carbon. The disadvantage of using composite material arises is that in case of implant failure, when revision surgery is warranted. This is because of the risk of fibre breakage and subsequent penetration of small fibre particles into the bone tissue, causing irritation and inflammation .
The increased use of bioresorbable polymers (i.e. polymers which degrade in-vivo to non-harmful by-products) in the recent year's poses the problem of their strength loss while bone-healing is in progress . It is to be noted that bone-plate fracture-fixation should sustain loads for 1.5 to 2 years , which is yet to be achieved with resorbable materials. Hence, a new class of resorbable materials needs to be developed, having adequate mechanical properties and resorbtion time increased by 1 to 2 years.
In view of the above discussion, polymers and calcium phosphates are osteoinductive and resorbable; they cannot behave as load-sharing members and fail in in-vivo loading conditions . For a reinforced fractured bone, it is important to initially have a plate with sufficient stiffness so as to prevent tensile stresses at the fracture interface, while allowing the bone away from the fracture site to be stressed under loading conditions (so as to prevent loss of bone strength). An optimal plate needs to be designed such that it caters to the above mentioned objectives.
Based on these considerations, we recommend the use of stiffness-graded materials (SGMs) for bone-plates. SGMs are characterized by a smooth and continuous change of the mechanical properties from one characteristic surface to the other. Stiffness-graded material is a relatively new concept in bone-plates in order to decrease stress shielding (this concept is well documented for dental implants) [23–26]. Controlled segregation, controlled blending, vapor deposition, plasma spraying, electrophoretic deposition, controlled powder mixing, slipcasting, sedimentation forming, centrifugal forming, laser cladding, metal infiltration, controlled volatilization, and self propagating high-temperature synthesis are few manufacturing techniques that are involved in fabrication of SGMs. Current production of SGMs is hampered by the current manufacturing process technology.
In this paper, a preliminary comparison of the stiffness graded plates with stainless steel plates is provided, with respect to bone healing stages and stress-shielding by means of finite element analysis. Herein, we have explored the viability of using stiffness-graded materials as bone-plates, in order to reduce the stress-shielding effect, by providing an inside view of the stresses in bone during various stages of healing.
Axial compressive load is more prominent in long bones . However, it does not endanger bone-healing by opening the fracture gap and it contributes to more interfragmentary compression at fracture interface. On the other hand, load eccentricity from the center of the bone-plate and the intrinsic curvature of long bones cause bending moments to be applied to the fracture fixed bone. Bending moment will induce both tension and compression stresses across the fracture interface, and open up the fracture, leading to the reduction in the stability of the fixation. Hence, bending loading is considered by us for finite element analysis of plate-reinforced bone.