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     RESEARCH ARTICLE
           Development of a Novel Hybrid Suture Anchor for
           Osteoporosis by Integrating Titanium 3D Printing and
           Traditional Machining
           Chih-Hwa Chen   1,2,3 , Wen-Jen Chang , Yu-San Chen , Kuan Hao Chen , Shao-Fu Huang ,
                                                                                2,7
                                                                                                   6,8
                                               4,5
                                                              6
           Hsin-Ru Hsueh , Cun-Bin Li , Chun-Li Lin *
                                                     6 ,8
                                       6
                          6
           1 School of Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan
           2 Department of Orthopedics, Taipei Medical University - Shuang Ho Hospital, New Taipei City, Taiwan
           3 School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
           4 Department of Information Management, Chang Gung University, Tao-Yuan, Taiwan
           5 Department of Dentistry, Chang Gung Memorial Hospital, Taoyuan, Taiwan
           6 Department of Biomedical Engineering, National Yang Ming Chiao Tung University, Taipei, Taiwan
           7 Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medial
           University, Taipei, Taiwan
           8 Innovation and Translation Center of Medical Device, National Yang Ming Chiao Tung University, Taipei, Taiwan
           Abstract: The aim of this study is to develop a titanium three-dimensional (3D) printing novel hybrid suture anchor (HSA) with wing
           structure mechanism which can be opened to provide better holding power for surrounding osteoporotic bone. A screw-type anchor
           (5.5-mm diameter and 16-mm length) was designed with wing mechanism as well as micro dual-thread in the outer cortex bone contact
           area and macro single-thread in the anchor body. Both side wings can be opened by an internal screw to provide better bone holding
           power. The suture anchor and internal screw were manufactured using Ti6Al4V 3D printing and traditional machining, respectively.
           Static pullout and after dynamic 300-cyclic load (150 N) pullout tests for HSA with or without the wing open and commercial solid
           anchor (CSA) were performed (n = 5) in severely osteoporotic bone and osteoporotic bone to evaluate failure strengths. Comparison
           of histomorphometrical evaluation was performed through in vivo pig implantation of HSAs with the wing open and CSAs. The
           failure strengths of HSA with or without the wing open were 2.50/1.95- and 2.46/2.17-fold higher than those of CSA for static and
           after dynamic load pullout tests in severely osteoporotic bone, respectively. Corresponding values for static and after dynamic load
           pullout tests were 1.81/1.54- and 1.77/1.62-fold in osteoporotic bone, respectively. Histomorphometrical evaluation revealed that the
           effects of new bone ingrowth along the anchor contour for CSA and HSA were both approximately 20% with no significant difference.
           A novel HSA with wing mechanism was developed using 3D printing and the opened wing mechanism can be used to increase bone
           holding power for osteoporosis when necessary. Better failure strength of HSA than CSA under static and after dynamic load pullout
           tests and equivalence of bone ingrowth along the anchor contours confirmed the feasibility of the novel HSA.
           Keywords: Suture anchor; Rotator cuff; 3D printing; Pullout; Failure strength
           *Correspondence to: Chun-Li Lin, Department of Biomedical Engineering, Innovation and Translation Center of Medical Device, National Yang
           Ming Chaio Tung University, Taipei, Taiwan; cllin2@nycu.edu.tw
           Received: May 3, 2022; Accepted: June 12, 2022; Published Online: August 26, 2022
           Citation: Chen CH, Chang WJ, Chen YS, et al., 2022. Development of a Novel Hybrid Suture Anchor for Osteoporosis by Integrating
           Titanium 3D Printing and Traditional Machining. Int J Bioprint, 8(4):608. http://doi.org/10.18063/ijb.v8i4.608
           1. Introduction                                     decreases while an anchor is inserted into osteoporotic
                                                               or osteopenic bone in the proximal  humerus, which
           Arthroscopic rotator cuff repair using suture anchors to   increases the failure rate of anchor treatment [3-5] . Several
           reattach torn rotator cuff tissue to the bone is an important   approaches, including buddy-system anchors, bone
           surgical treatment [1,2] . However, bone holding power   grafting,  cement  augmentation,  and changing  anchor
           © 2022 Author(s). This is an Open-Access article distributed under the terms of the Creative Commons Attribution License, permitting distribution and
           reproduction in any medium, provided the original work is properly cited.
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