Additive manufactured polyether-ether-ketone implants for orthopaedic applications: a narrative review

doi:10.12336/biomatertransl.2022.02.001

Biomaterials Translational ›› 2022, Vol. 3 ›› Issue (2): 116-133.doi: 10.12336/biomatertransl.2022.02.001

• REVIEW • Previous Articles Next Articles

Additive manufactured polyether-ether-ketone implants for orthopaedic applications: a narrative review

Changning Sun¹^,², Jianfeng Kang³, Chuncheng Yang¹, Jibao Zheng¹^,², Yanwen Su¹^,², Enchun Dong¹^,², Yingjie Liu¹^,², Siqi Yao¹^,², Changquan Shi¹, Huanhao Pang¹^,², Jiankang He¹^,², Ling Wang¹^,²^,^*(), Chaozong Liu⁴, Jianhua Peng⁵, Liang Liu⁵, Yong Jiang⁵, Dichen Li¹^,²^,^*()

1 State Key Laboratory for Manufacturing System Engineering, School of Mechanical Engineering, Xi’an Jiaotong University, Xi’an, Shaanxi Province, China
2 National Medical Products Administration (NMPA) Key Laboratory for Research and Evaluation of Additive Manufacturing Medical Devices, Xi’an Jiaotong University, Xi’an, Shaanxi Province, China
3 Jihua Laboratory, Foshan, Guangdong Province, China
4 Institute of Orthopaedic & Musculoskeletal Science, University College London, Royal National Orthopaedic Hospital, Stanmore, UK
5 Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan Province, China

Received:2022-01-26 Revised:2022-03-09 Accepted:2022-06-08 Online:2022-06-28 Published:2022-06-28
Contact: Ling Wang,Dichen Li E-mail:menlwang@mail.xjtu.edu.cn;dcli@mail.xjtu.edu.cn
About author:Dichen Li, dcli@mail.xjtu.edu.cn.
Ling Wang, menlwang@mail.xjtu.edu.cn;

Abstract

Abstract:

Polyether-ether-ketone (PEEK) is believed to be the next-generation biomedical material for orthopaedic implants that may replace metal materials because of its good biocompatibility, appropriate mechanical properties and radiolucency. Currently, some PEEK implants have been used successfully for many years. However, there is no customised PEEK orthopaedic implant made by additive manufacturing licensed for the market, although clinical trials have been increasingly reported. In this review article, design criteria, including geometric matching, functional restoration, strength safety, early fixation, long-term stability and manufacturing capability, are summarised, focusing on the clinical requirements. An integrated framework of design and manufacturing processes to create customised PEEK implants is presented, and several typical clinical applications such as cranioplasty patches, rib prostheses, mandibular prostheses, scapula prostheses and femoral prostheses are described. The main technical challenge faced by PEEK orthopaedic implants lies in the poor bonding with bone and soft tissue due to its biological inertness, which may be solved by adding bioactive fillers and manufacturing porous architecture. The lack of technical standards is also one of the major factors preventing additive-manufactured customised PEEK orthopaedic implants from clinical translation, and it is good to see that the abundance of standards in the field of additive-manufactured medical devices is helping them enter the clinical market.

Key words: 3D printing, additive manufacturing, customised implant, polyether-ether-ketone

Cite this article

Figures/Tables 12

Figure 1. Design criteria for three-dimensional printed customised implant.

Figure 2. Flowchart of the design process. 3D: three-dimensional; CT: computed tomography; FEA: finite element analysis; N: no; Y: yes.

Figure 3. The manufacturing process of a PEEK implant. 3D: three-dimensional; PEEK: polyether-ether-ketone.

Figure 4. 3D-printed PEEK cranioplasty patch. (A) CT image. (B) 3D model of the defected skull. (C) 3D model of cranioplasty patch (yellow). (D) Cranioplasty patch (red) within CT image. (E) 3D-printed PEEK cranioplasty patch. (F) Intraoperative photograph. 3D: three-dimensional; CT: computed tomography; PEEK: polyether-ether-ketone.

Figure 5. Design and application of an implant for paranasal augmentation. (A) Pre-operative design of the implant. (B) A 3D-printed porous PEEK/BaSiO4 implant. (C) Intraoperative view of a paranasal implant fixed with screws. (D, E) Pre-operative (D) and 3-month post-operative (E) comparison through CT models. 3D: three-dimensional; CT: computed tomography; PEEK: polyether-ether-ketone.

Figure 6. 3D-printed PEEK implant for mandibular defect repair. (A) CT image. (B) 3D model with tumour (blue). (C) 3D model of the mandible. Dotted outline indicates the location of the tumour. (D) Pre-operative planning for fibula graft and (E) implantation. (F) FEA results of PEEK implant and Ti plate. (G) 3D printed PEEK mandibular prosthesis. (H) Intraoperative photograph. 3D: three-dimensional; CT: computed tomography; FEA: finite element analysis; PEEK: polyether-ether-ketone; Ti: titanium.

Figure 7. 3D-printed PEEK implant for chest wall reconstruction. (A) CT image. (B) 3D model with tumour (blue). (C) 3D model of the thoracic cavity and rib prosthesis (yellow). (D) 3D printed rib prosthesis. (E) FEA results. (F) Results of mechanical testing. (G) Intraoperative photograph. (H, I) Design (H) and implantation (I) of the costal arch prosthesis. (J, K) Design (J) and implantation (K) of the sternum prosthesis. The yellow indicates the implant, and the blue indicates the tumour. 3D: three-dimensional; CT: computed tomography; FEA: finite element analysis; PEEK: polyether-ether-ketone.

Figure 8. 3D-printed PEEK scapula prosthesis. (A) Design. (B) Strength evaluation. (C) Photograph of scapula prosthesis. (D) Intraoperative photograph. 3D: three-dimensional; PEEK: polyether-ether-ketone.

Figure 9. Clinical application of a 3D-printed PEEK radial prosthesis. (A) CT image. (B) Surgical plan of radial reconstruction. (C) Design of the radial prosthesis. (D) Photograph of the 3D-printed PEEK radial prosthesis. (E) Photographs of the prosthesis, tumour and medical model. (F) Intraoperative photograph. 3D: three-dimensional; CT: computed tomography; PEEK: polyether-ether-ketone.

Figure 10. 3D-printed PEEK femoral segmental prosthesis. (A) 3D model of the femur with tumour. (B) Femur of healthy side. (C) FEA results of the PEEK femoral prosthesis. (D) Force-displacement curve of the 3D-printed PEEK femoral prosthesis. (E) Intraoperative photograph. 3D: three-dimensional; FEA: finite element analysis; PEEK: polyether-ether-ketone.

Figure 11. Biological evaluation of HA/PEEK composites. (A) In vitro cell experiment. (B) Bone-ingrowth in scaffolds of PEEK and 40 wt% HA/PEEK. The red circle indicates the outline of PEEK and HA/PEEK scaffolds in CT images. HA: hydroxyapatite; PEEK: polyether-ether-ketone.

Figure 12. (A) Schematic diagram of screw extrusion printing equipment and (B) heterogeneous specimen. CF: carbon fibre; HA: hydroxyapatite; PEEK: polyether-ether-ketone.

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Additive manufactured polyether-ether-ketone implants for orthopaedic applications: a narrative review

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