Carbon fibre reinforced (CFR) polyetheretherketone (PEEK) is used in orthopedic implants that produces similar bone modulus that has the ability to withstand prolonged fatigue strain (Frank et al., 2014). During the year 1860, Joseph Swan was the first person to use carbon fibers in light bulbs. Then in 1879, Thomas Edison used bamboo silvers and baked cotton at high temperatures to a filament made of carbon-fiber that was used to heat bulbs by electricity. On the other hand, PEEK emerged as a composite material in 1977 developed by English Victrex and they became the sole manufacturer of the PEEK. Later, in collaboration with Indian Gharda, Victrex established the semi-industry of the devices made of PEEK in Bombay. In 1980, PEEK was developed by the company named Changchun Jida High Performance Materials Co., Ltd. And from there the commercial production of PEEK started in the early 1990s (De Volder et al., 2013).
Over the years, CFR PEEKs were being used and during the year 1960s, in Lancashire, United Kingdom, Sir John Charnley and his team at the Wrightington Hospital pioneered the development of hip implants that are of low-friction by using this composite material. However, the in vivo use of this material was still unpopular and was not successful. There were issues of sterility, toughness, durability and biocompatibility when used in vivo. Finally, in 1990, it was proposed that this composite material would be used as a material for base polymer (Said, 2014).
In the last 15 years, this composite material is being used in the medical industry for the manufacturing of human based implantable devices in vivo. Carbon fibers along with PEEK based on 30%-by-weight was evaluated and approved for medical applications especially in spinal implants. This composite material overcame the limitations of mechanical strength and this hybrid approach worked successfully when combined with a metallic component. The impregnated carbon-fiber PEEK based tape material developed in the recent years with a 62% by volume offering high mechanical performance to be used in orthopedic implants and helped in bridging the gap between metals and polymers (Sastri, 2013).
The composite structure is made of short carbon fibers that are dispersed within the PEEK-OPTIMA polymer matrix. This structure offers a enhanced physical and mechanical strength that is load bearing in the implants and applications that involves blood, tissue or one contact for more than thirty days. It is available in both unidirectional and multidirectional forms. In unidirectional, the carbon fibers are aligned along the principal stress direction or along one axis. In multidirectional, there is offset of subsequent layers in 45° or 90° to the reference axis which is advantageous in providing more-balanced properties as compared to in-plane in different directions (Ajami, Blunn & Coathup, 2016).
Crystallization-induced micro phase separation technique is preferably used to prepare the CFR PEEK composite material. Firstly, the crystalline polymer is dissolved in the melt of the crystalline in which a diluent and low-melting organic compound is used to form a one phase liquid system of the diluent and polymer. Secondly, there is quick quenching of the diluent and polymer by the sublimation below the melting temperature of the polymer and the extraction of diluent with a solvent that does not dissolve in the polymer phase. This application is highly used in the preparation of the CFR PEEK implants (Panayotov et al., 2016).
For example, in the surgical implantation of the right hind limb, a pilot hole is opened using a hand drill. Then, it is reamed distally into the femoral canal at an interval of 0.5 mm until the reaming has machined the endosteal walls proximal diaphysis. Broaching was done by preparing a 0.25 mm canal that is undersized for the press-fit. Further, the CFR PEEK was implanted by the gentle tapping in cement less procedure. For the cemented implantation, a single broach of 0.5 mm of oversized canal was used and then was lavaged and dried. CFR PEEK mounted with PMMA bone cement was inserted and pressure was applied until the cement is cured (Najeeb et al., 2015).
CFR PEEKs are used in medical applications because of its stiffness, tensile strength and fatigue behavior. The stiffness and strength were tailored to be used as a metal replacement in orthopedic or structural implants. It has an excellent bone-like modulus and wear performance for the orthopedic implant use. It offers the excellent retention and highest chemical resistance up to 300°C or 570°F. It is a true structural polymer in the articulation of joints against counter faces. The stiffness and structure of cortical bone is ~15-2 GPs and the multidirectional CFR-PEEK offers the same stiffness as the bone as compared to titanium alloys. Apart from stiffness, CFR PEEK also provides immense strength as compared to metallic materials. The tensile strength is also excellent as an excess of 900 MPs in the multidirectional CFR PEEK can provide more strength than titanium alloys of 6AI-4V, 316 stainless steel and cobalt chrome alloys prepared using a variety of methods (Li et al., 2015).
This composite material also provides exceptional strength in fiber-matrix interfacial bond as the interfacial strength between the PEEK and carbon fibers have high magnitude as compared to other materials like Ultra High Molecular Weight Polyethylene (UHMWPE). It also offers a superior creep performance as compared to UHMWPE. It has durability and stability with excellent biocompatibility and anti-ageing material. It demonstrated good wear performance in total hip joint replacement and has the potential to reduce the thickness of the inserted tibia and helps in the preservation of the bone in the total hip joint replacement surgery (Brockett et al., 2017).
The previous implants of polyethylene have high contact stress, inadequate mechanical properties and poor oxidative stability that led to the failure resulting in material delamination and fatigue failure. CFR PEEK has tailored mechanical attributes over other UHMWPE because it has short carbon fibres that significantly increase the strength of unfilled natural polymer that addresses the needs of stress tolerance at a high level. In orthopaedic applications, CFR-PEEK has flexural stiffness and bone resorption that is similar to the cortical bone that helps to reduce the complications that are associated with the stress shielding (Stratton-Powell et al., 2016).
CFR PEEK has many advantages over other composite materials that are used in medical applications. It has excellent wear performance in the articulation of joints that is advantageous over the UHMWPE material for bearing surfaces and joint prostheses. It demonstrates superior wear performance against metal, ceramic and polymeric counter faces. It has excellent life spans when used in implants and the metallic wear debris can also be avoided. It is greatly beneficial over UHMWPE as it demonstrates mechanical properties like lower weight in prostheses, thinner parts and greater flexibility in designing. The hip stimulator showed less wear performance in CFR PEEK as compared to ceramic counter faces and UHMWPE. It has high proven biocompatibility as it does not show evidence for irritation, systemic toxicity, macroscopic reactions or cytotoxicity (Tarallo et al., 2016).
CFR PEEK has great advantage over flexibility in design and processing. This composite material is also available in granular form for extrusion or injection moulding. It has exceptional interfacial bond strength in fibre-to-matrix that enhances the durability and strength of the composite material. It also reduces the stress shielding due to the bone-like stiffness and great biocompatibility that ensures long term and safe implantation. It is highly X-rays, MRI and CT scan compatible as it is radiolucent in nature. It is Food and Drug Administration (FDA) approved and high successful in long term orthopaedic implants. The impregnated tape made of CFR PEEK has significant imaging compatibility. It enables artifact-free postoperative imaging and has the ability to view bone and tissue growth and repair through X-ray and CT techniques (Schliemann et al., 2015). As the material is non-metallic, it is MRI compatible and gives a clear image for clinical investigation. It is biocompatible with the sterilization methods. CFR PEEK is resilient to sterilization with no changes in mechanical properties. It is non-toxic as it does not release any material in cytotoxic concentrations. It closely matches the module of natural bone with high strength, biocompatibility and good fatigue resistance.
Apart from advantages, there are few disadvantages of using this composite material. The material cannot be contoured so it has limited uses in fracture fixation like straight diaphyseal fractures and requires a locking screw technique in an automatically designed plate. The enhanced flexibility is also disadvantageous as it might lead to pseudarthrosis. The increased fatigue strength of the composite material decreases the risk for fatigue failure. It is highly expensive and the material once broken or cracked down requires removal and replacement. Moreover, the recycling of the carbon fibre reinforced PEEK is also a matter of great concern (Hak et al., 2014).
CFR PEEK is widely used in orthopedic implants like spinal cages, high tibial osteotomy, musculoskeletal oncology, translaminar facet screws, intervertebral spacers and cervical plates in traumatology and orthopedics. As it does not readily break down and is readily accepted by the body, it is used in knee replacement surgeries. It acts as a biomaterial in spinal fusion and lumbar inter-body fusion cages. It has applications in cervical spine surgery as a carbon-fiber composite material in anterior cervical plating system introduced first in Europe. CFR PEEK plates are used for fracture fixation and high tibial osteotomy plates are in use for fracture treatment. However, these CFR composite plates cannot be bent or contoured. It is also used in joint arthroplasty in the low-friction hip implants and acts as a metal replacement in orthopedic surgeries. It is used in the improvement of prosthetics for the replacement or repairing of the bones and has immense uses in orthopedic surgeries. It is also used in proximal humerus locking plates with greater screw fixation and an excellent option for the replacement of metallic plates. It is also used in making of intermedullary nails, translaminar fixation pins and screws (Katthagen et al., 2016).
CFR PEEK is also used neurological and cardiac leads in orthopedic implants for the knee replacement products in knee joints have less wear than UHMWPE. The cement less and cemented CFR PEEK is used in unilateral hip joint replacement and in fracture fixation like tibial nail, distal radius volar plates and dynamic compression plates. They are better alternatives than titanium alloys available in commercially available nails and screws. CFR PEEKs are also widely used in fracture fixation plate in orthopaedics and in preparation of medical devices. CFR PEEK composite materials are also effectively used in the hip resurfacing in which it is used with the Mitch PCR acetabular component showing good results (Nakahara et al., 2014).
The carbon fibers containing composite materials have adverse effects on the environment. The carbon fiber dusts have potential toxicity on the environment and humans. Carbon fiber based impregnated PEEK cannot be reused or melted like steel and when it is recycled, it loses its strength to a considerable amount. It is fairly a new process of recycling of carbon fiber composites and until now, there is no process for the recycling of carbon fiber based composite materials (da Costa et al., 2016). This depicts that it pose an environmental threat as it cannot be recycled and is dumped into the waste stream that ends up in scrap. The recycling process is very expensive and the cost is equivalent to manufacturing of new CRF PEEKs. The carbon fibers do not degrade, corrode, rust or undergo fatigue, so it has a longer lifecycle than steel that requires continuous replacement. However, steel can be recycled innumerable times, but, carbon fiber based composites require pose a threat to the environment as it cannot be recycled. The dust of the carbon fibers affects the cells of the lungs and requires occupational exposure limits for the composite material. The manufacturing of carbon fiber composite materials require high amount of heat with extensive exhaust of fumes, so it is manufactured under strict vigilance of environmental community to reduce the energy demands involved in the process (Hammouche et al., 2016).
The pollutants are extremely dangerous for the humans, even in low quantities. So, Anguil Environmental Systems in United States have developed a multi-staged Direct Fired Thermal Oxidizer (DFTO) to destroy the harmful nitrogenous compounds and thereby, reduces the environmental impact.
In humans, CFR PEEK showed elevated cytokine expression in a study conducted by Lorber et al., (2014) where there is enhanced cytokine production (IL-1β, TNF-α, IL-6) acting as a negative predictor in knee arthroplasty as compared to UHMWPE used as a bearing material. Another study conducted by Suska et al., (2014) showed that CFR-PEEK displayed inferior biocompatibility as compared to titanium alloy for in vivo implantation. Titanium alloy was a preferable control as compared to CFR PEEK as it has a lesser bone response until coated with hydroxyapatite (Brockett et al., 2016). This shows that although, the composite material has many advantages, there are minimal adverse effects in vivo implantation.
References
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