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 Table of Contents  
REVIEW ARTICLE
Year : 2018  |  Volume : 3  |  Issue : 1  |  Page : 12-16

Medical applications of polyether ether ketone


1 Department of Mechanical Engineering and Aerospace, Polytechnic of Turin, Turin, Italy
2 School of Mechanical Engineering, Dongguan University of Technology, Dongguan, Guangdong, China
3 Collaborative Innovation Center of High-End Manufacturing Equipment, Xi'an Jiaotong University, Xi'an, Shaanxi; National Institute Corporation of Additive Manufacturing, Xi'an, School of Mechanical Engineering, Dongguan University of Technology, Dongguan, Guangdong, China

Date of Submission28-Feb-2018
Date of Acceptance12-Mar-2018
Date of Web Publication22-Mar-2018

Correspondence Address:
Bingheng Lu
Collaborative Innovation Center of High-End Manufacturing Equipment, Xi'an Jiaotong University, Xi'an 710049, Shaanxi; National Institute Corporation of Additive Manufacturing, Xi'an, School of Mechanical Engineering, Dongguan University of Technology, Dongguan 523808, Guangdong
China
Jing Wang
Collaborative Innovation Center of High-End Manufacturing Equipment, Xi'an Jiaotong University, Xi'an 710049, Shaanxi; National Institute Corporation of Additive Manufacturing, Xi'an, School of Mechanical Engineering, Dongguan University of Technology, Dongguan 523808, Guangdong
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ts.ts_3_18

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  Abstract 


Polyether ether ketone (PEEK) has been widely used during the past decades in the medical field. Its versatile nature makes PEEK very popular in a variety of medical devices. The purpose of this article is to summarize the medical applications of PEEK in following fields: cranioplasty, dental implants, interbody fusion, joint replacements, soft-tissue repairs, and cardiac surgery. PEEK, as a biocompatible polymer, has been used in fields related to tissue fixation and reconstruction. This is largely due to its superior mechanical characteristics and biocompatibility. The author believes that as collaboration between medical professionals and engineers becomes more standard, PEEK and its composites will become more available and versatile.

Keywords: Bone reconstruction, implant, polyether ether ketone, surgery, tissue repairs


How to cite this article:
Guo Y, Chen S, Wang J, Lu B. Medical applications of polyether ether ketone. Transl Surg 2018;3:12-6

How to cite this URL:
Guo Y, Chen S, Wang J, Lu B. Medical applications of polyether ether ketone. Transl Surg [serial online] 2018 [cited 2018 Jun 20];3:12-6. Available from: http://www.translsurg.com/text.asp?2018/3/1/12/228312




  Introduction Top


Polyether ether ketone (PEEK) was originally introduced by Victrex PLC, and Imperial Chemical Industries (ICI) put it into use in the early 1980s.[1] It is in the polyaryletherketone family and widely used in different engineering applications. PEEK has versatile mechanical and chemical properties that are retained at high temperature. Young's modulus is 3.6 GPa, and it has a tensile strength of 90-100 MPa.[2] PEEK has a glass transition temperature of around 143°C and melts around 343°C. Some grades have a useful operating temperature of up to 250°C. The thermal conductivity increases nearly linearly with temperature between room temperature and solidus temperature.[3] In addition, it has a high resistance to both thermal degradation and biodegradation.

From the biomedical perspective, PEEK has excellent cell biocompatibility, radiolucency, and mechanical properties similar to those of human cortical bones.[1],[2] Hence, in recent years, PEEK has been adopted in an increased number of medical fields, including cranioplasty, dental implants, interbody fusion, total joint arthroplasty (TJA), and applications to soft-tissue repair. In this review, representative studies (including retrospective reviews, experimental investigations, and finite element model analyses) and case reports are described to demonstrate the impact of PEEK in such medical fields.


  Polyether Ether Ketone for Cranioplasty Top


Starting with the Incan and Egyptian's use of gourds and fine gold plates for reconstruction of skulls, cranioplasty has entered the modern era of three-dimensional (3D) modeling and now uses a variety of high-tech materials.[4],[5] As an advanced material for cranioplasty, PEEK (1) simulates bone in terms of strength (113 vs. 115 MPa) and elasticity (3.6–4.1 vs. 8–24 GPa), (2) can avoid stress shielding and thermal conduction better than metallic implants, (3) is easily modified in the operating room, (4) may be resterilized and reused after a quiescent period of time following failure from infection, and (5) is particularly durable.[6],[7],[8]

In 2007, Scolozzi et al.[9] used a PEEK implant for the first time. The patient underwent surgery to reconstruct a cranial bone defect caused by a previous surgical failure involving a titanium mesh with methylmetacrylate cement. According to the clinical report, the implant perfectly matched the dimensions of the residual bone defect, and a 1-year follow-up showed a stable cosmetic and dimensional reconstruction, no infection, and the persistence of a small left temporal depression related to an atrophied temporal muscle.[9]

Cranioplasty with PEEK was later compared to both cranioplasty with autologous and with titanium. In 2014, Gilardino et al.[10] found that both the operating time and the number of cases requiring Intensive Care Unit admission were lower in the custom computer-generated implants (CCGIs) group compared to the titanium group. Most of these were patient-specific implants using PEEK. Moreover, the length of hospital stay was shorter and the number of cases needing transfusion was fewer in the CCGI group. After a 1-year follow-up, it was found that there were no complications in the CCGI group; however, 47% of patients in the autologous cohort presented with complications.[10]

Similarly, in the same year, Thien et al.[11] studied retrospective records of patients who underwent PEEK and titanium cranioplasty to compare complication and failure rates between two types of implants. The results showed that the overall complication rates for PEEK and titanium cranioplasty were 25.0% and 27.8%, respectively. They found an increasing trend in exposed implant in titanium compared with PEEK cranioplasty, but this was not significant. Moreover, the failure rate of PEEK cranioplasty (12.5%) was lower than that of titanium (25%). However, the difference between the two groups was statistically insignificant. Following their study, the authors concluded that there were no statistically significant differences in complication rate between titanium and PEEK cranioplasty.[11]


  Polyether Ether Ketone for Dental Implants Top


PEEK has been shown to have a resistance to degradation in vivo and as of April 1998 has been offered commercially as a biomaterial for long-term implants.[12] Its subsequent use in dentistry has been substantial after its wide-scale acceptance in other medical fields. PEEK is a physiologically inert, water-insoluble, high-performance polymer. Although lacking long-term clinical trials, PEEK seems to be a suitable superstructure in dentistry based on its unique physical and biological properties, namely, for dental implants, abutments, implant-supported bars, clamps, and dental prosthesis.[13]

To better understand mechanical properties of PEEK, Schwitalla et al.[14] performed static pressure tests with 11 PEEK materials (including unfilled, filled, and reinforced grades). They tested and evaluated elastic modulus, elastic limit, and pressure strength. The elastic modulus for specimens reinforced with continuous carbon fibers was 40 times greater than that for specimens of a titanium-dioxide-filled grade. Further, the elastic limit for specimens reinforced with continuous carbon fibers was nearly 9 times greater than that of a barium-sulfate-filled grade. The specimens containing continuous carbon fibers demonstrated the highest pressure strength, while those of unfilled grade demonstrated the lowest. Based on these favorable results, the authors concluded that a convergence of the elastic modulus to the peri-implant bone modulus was feasible, therefore, guaranteeing an isoelastic transition.[14]

An experimental study in dogs was conducted by Rea et al.[15] to evaluate the potential of PEEK as healing abutment. Four different types of healing abutments were positioned on the top of each implant: (1) titanium; (2) PEEK material bonded to a base made of titanium; (3) pristine PEEK; and (4) roughened PEEK. The results of this experiment showed that a higher resorption of the buccal bone crest was found using PEEK bonded to titanium, compared to the titanium abutment sites. However, similar dimensions of the peri-implant mucosa, as well as similar locations of the soft tissues in relation to the implant shoulder, were observed. The difference in outcomes between pure and roughened PEEK was not shown to be statistically significant.[15]

A case report was documented by Sinha et al.,[16] where unfilled PEEK Optima (Invibio) was adopted as a framework for fixed partial dentures (FPD). According to their follow-up records, there was very little plaque accumulation, but healthy gingival around the teeth, indicating a biocompatibility of PEEK. Moreover, the lightweight nature of PEEK promoted higher patient comfort levels. Given these satisfactory results, researchers considered that PEEK would play a more important role in the future of FPD frameworks.[16]


  Polyether Ether Ketone for Interbody Fusion Top


Cage technology for spinal fusion was first proposed by Bagby in 1988.[17] Multiple cage materials have been considered, however, limitations have been identified for each candidate material. In particular, the most commonly used materials for interbody cages are titanium and PEEK. Both of these materials have demonstrated satisfactory biocompatibility.[18]

Seaman et al.[19] conducted a systematic review and meta-analysis of all available literature focusing on the role of titanium and PEEK cages in the spinal surgery. They also looked at associated surgical and radiographic outcomes, including cage subsidence, fusion rates, and patient-reported outcomes.[19] According to their results, surgical success (defined as excellent vs. good clinical outcome based on persistence of symptoms) ranged from 55% to 75% for Ti group and from 64.3% and 80% for the PEEK group. Further, fusion rates ranged from 46.51% to 100% for the Ti group and from 76% to 100% for the PEEK group. In addition, subsidence rates ranged from 16% to 35% for the Ti group and from 0% to 28% for PEEK group. Finally, the authors suggested that titanium and PEEK cages were associated with comparable fusion rates, but titanium cages were associated with an increased risk of subsidence.[19]

Although PEEK is biocompatible and radiolucent, it is hydrophobic, which can limit bony ingrowth. Therefore, McGilvray et al.[20] proposed a PEEK titanium composite (PTC) cage for use in lumbar fusion, and examined the interbody fusion features of such a cage. In their study, PEEK was compared with PTC by applying two different kinds of cages on 34 mature female sheep, which underwent two-level interbody fusions. They found that compared with the standard PEEK cages, the PTC constructs showed an increase in stiffness, but a reduction in range of motion. The authors concluded that PTC cages could potentially lead to a stronger intervertebral fusion, compared to standard PEEK devices.[20]

Structural allograft is also a commonly used interbody fusion device. Regarding anterior cervical discectomy and fusion (ACDF), allografts and PEEK make up 92% of interbody spacers use.[21] Yson et al.[22] retrospectively reviewed ACDF cases from November 2005 to September 2012 at one institution, and compared the subsidence rate of allograft cages and PEEK cages in ACDF. Following their study, the authors found that the subsidence rate did not appear to be affected by the use of either PEEK or allograft as spacers in ACDF.[22]


  Polyether Ether Ketone for Total Joint Arthroplasty Top


Failures of TJA can be characterized into five aspects: (1) aseptic loosening, (2) infections, (3) polyethylene wear/osteolysis, (4) instability, and (5) periprosthetic bone fractures.[23],[24],[25] At least three of these failure types can be induced by stress shielding. A possible solution is the use of more compliant materials, thereby allowing loads to be distributed more physiologically over the periprosthetic bone. Therefore, over the last few years, efforts have been made to study the potential of an all-polymer total joint replacement.[26],[27],[28],[29],[30],[31],[32] As such, PEEK and its carbon fiber composites were introduced as bearing materials for TJA in the 1990s.[33]

de Ruiter et al.[34] studied the mechanical response of a PEEK-on-polyethylene total knee replacement device during a deep squat. The researchers compared several mechanical parameters between PEEK and cobalt-chromium, using a finite element model of a TKA subjected to a deep squat loading condition. They found that stress shielding was reduced to a median of 1% for the PEEK implant versus 56% for the cobalt–chromium implant. Hence, they concluded that compared to the cobalt–chromium component, stress shielding of the periprosthetic femur was less with a PEEK femoral component.[34]

Besides mechanical properties, it is imperative to identify whether or not the wear debris produced by PEEK devices is either cytotoxic or immunologically reactive, since many total joint arthroplasties fail as a result of biologic responses to particles.[35],[36] Stratton-Powell et al.[37] ran a systemic review to find out that whether the PEEK wear particles cause an adverse biologic response when compared with ultrahigh-molecular-weight polyethylene or a similar negative control biomaterial. From their published results, they concluded that wear particles produced by PEEK-based bearing in TJA wear simulators were, in almost all cases, in the phagocytable size range (0.1–10 μm). Further, the biological response to PEEK-based particles has thus far been generally found not to cause cytotoxic effects. They have, however, been shown to be variable when considering inflammatory cytokine release.[37]


  Polyether Ether Ketone for Soft-Tissue Repair Top


Applications of PEEK to the field of soft-tissue repairs were also reviewed in this paper. Li et al.[38] developed and tested a silk-based anterior cruciate ligament (ACL) graft, combined with a tricalcium phosphate (TCP)/PEEK anchor. PEEK was used as the material for the anchor due to its suitable biocompatibility and biomechanical behavior, as well as, its mechanical fixation and initial stability. They tested both the safety and efficacy of this idea in a porcine model. Following this study, the authors concluded that both initial stability and robust long-term biological attachment were consistently achieved using the tested construct. These results support the use of silk-TCP combinations in the repair of a torn ACL.[38]

Another study regarding PEEK in soft-tissue repair was conducted by Christensen et al.[39] The aim of their study was to define the pullout strength and failure mode for the PEEK bullet-in-sheath tenodesis device. Although other materials were used for screws, such as titanium and bioabsorbable polymers, there were problems (e.g., laceration of soft tissues) resulting in graft failure at the screw-graft interface and side effects (such as foreign body effects) caused by degradation products.[40],[41],[42] Therefore, the authors adopted a PEEK approach in an effort to diminish or eliminate such adverse reactions. Finally, the authors concluded that PEEK sheath-based interference devices may be a viable option regarding foot and ankle soft-tissue repairs.[39]

PEEK has also been successfully applied to urological surgery at Tangdu Hospital of Fourth Military Medical University. Zhang Bo, the deputy director of the Department of Urology, and his team developed a patient-specific extravascular stent made of PEEK, which became an effective treatment for nutcracker syndrome (NCS). Although the application of 3D printing PEEK material for soft-tissue treatment is a small step forward, it has a far-reaching influence on the application of PEEK material in the medical field.


  Polyether Ether Ketone for Cardiac Surgery Top


PEEK has been applied in cardiac surgeries in recent years. In 1994, Leat and Fisher [43] studied a new geometry for the design of polyurethane leaflet heart valves. In this design, the frame of the valve was made of PEEK, which was then coated with a thin layer of leaflet polymer.[43] Another example of PEEK application in the cardiac field is the construction of a microaxial pump rotor.[44] The pump is for intracardiac left and right ventricular assistance, and it is made out of Victrex PEEK™ polymer (Impella AG, FRG). The device may be able to replace the heart–lung machine and is generally less invasive than other technologies.[44]


  Conclusion Top


The application of PEEK to medicine has been investigated for a relatively wide range of use. Due to its high strength and modulus that approximates human bone, PEEK has been comprehensively used in many procedures, including implants, bone reconstruction, and tissue repair. The unique combination of biocompatibility and chemical resistance makes PEEK an interesting alternative compared to titanium or other biomaterials. This is particularly true for surfaces and parts that directly contact bio fluids, whether during chemical analysis or a surgical procedure. Moreover, the characteristic of radiolucency is also valuable, as it allows implants to remain undetectable to standard-of-care medical imaging, including computed tomography, magnetic resonance imaging, and X-ray modalities. This review briefly summarized different PEEK applications. The authors believe that as collaboration between medical professionals and engineers becomes more standard, PEEK and its composites will become more available and versatile.

Financial support and sponsorship

This study was financially supported by Donguan University of Technology High-level Talents (Innovation Team) Research Project (KCYCXPT 2016003) and Shaanxi Provincial Science and Technology Planning Project (2017KTZD6-01).

Conflicts of interest

There are no conflicts of interest.



 
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