Development of a Novel Hybrid Suture Anchor for Osteoporosis by Integrating Titanium 3D Printing and Traditional Machining

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.
1. Chaudhry S, Dehne K, Hussain F, 2019, A Review of Suture Anchors. Orthop Trauma, 33:263–70. http://doi.org/10.1016/j.mporth.2016.12.001
2. Ma R, Chow R, Choi L, et al., 2011, Arthroscopic Rotator Cuff Repair: Suture Anchor Properties, Modes of Failure and Technical Considerations. Expert Rev Med Devices, 8:377–87. http://doi.org/10.1586/erd.11.4
3. Braunstein V, Ockert B, Windolf M, et al., 2015, Increasing Pullout Strength of Suture Anchors in Osteoporotic Bone using Augmentation--a Cadaver Study. Clin Biomech, 30:243–7. http://doi.org/10.1016/j.clinbiomech.2015.02.002
4. Horoz L, Hapa O, Barber FA, et al., 2017, Suture Anchor Fixation in Osteoporotic Bone: A Biomechanical Study in an Ovine Model. Arthroscopy, 33:68–74. http://doi.org/10.1016/j.arthro.2016.05.040
5. Rosso C, Weber T, Dietschy A, et al., 2020, Three Anchor Concepts for Rotator Cuff Repair in Standardized Physiological and Osteoporotic Bone: A Biomechanical Study. J Shoulder Elbow Surg, 29:e52–9. http://doi.org/10.1016/j.jse.2019.07.032
6. Chae SW, Kang JY, Lee J, et al., 2018, Effect of Structural Design on the Pullout Strength of Suture Anchors for Rotator Cuff Repair. J Orthop Res, 36:3318–27. http://doi.org/10.1002/jor.24135
7. Barber FA, Herbert MA, Hapa O, et al., 2011, Biomechanical Analysis of Pullout Strengths of Rotator Cuff and Glenoid Anchors: 2011 Update. Arthroscopy, 27:895–905. http://doi.org/10.1016/j.arthro.2011.02.016
8. Tingart MJ, Apreleva M, Lehtinen J, et al., 2004, Anchor Design and Bone Mineral Density Affect the Pull-out Strength of Suture Anchors in Rotator Cuff Repair: Which Anchors are Best to Use in Patients with Low Bone Quality? Am. J. Sports Med, 32:1466–73. http://doi.org/10.1177/0363546503262644
9. Trindade R, Albrektsson T, Galli S, et al., 2018, Bone Immune Response to Materials, Part I: Titanium, PEEK and Copper in Comparison to Sham at 10 Days in Rabbit Tibia. J Clin Med, 7:526. http://doi.org/10.3390/jcm7120526
10. Alan Barber F, Boothby MH, Richards DP, 2006, New Sutures and Suture Anchors in Sports Medicine. Sports Med. Arthrosc, 14:177–84. http://doi.org/10.1097/00132585-200609000-00010
11. McFarland EG, Park HB, Keyurapan E, et al., 2005, Suture Anchors and Tacks for Shoulder Surgery, Part 1: Biology and Biomechanics. Am J Sports Med, 33:1918–23. http://doi.org/10.1177/0363546505282621
12. Guyer RD, Abitbol JJ, Ohnmeiss DD, et al., 2016, Evaluating Osseointegration into a Deeply Porous Titanium Scaffold: A Biomechanical Comparison with PEEK and Allograft. Spine, 41:E1146–50. http://doi.org/10.1097/brs.0000000000001672
13. Huang S, Narayan RL, Tan JH, et al., 2021, Resolving the Porosity-unmelted Inclusion Dilemma during in-situ Alloying of Ti34Nb Via Laser Powder Bed Fusion. Acta Mater, 204:116522. http://doi.org/10.1016/j.actamat.2020.116522
14. Wang D, Liu L, Deng G, et al., 2022, Recent Progress on Additive Manufacturing of Multi-material Structures with Laser Powder Bed Fusion. Virtual Phys Prototyp, 17:329–65. http://doi.org/10.1080/17452759.2022.2028343
15. Yu W, Xiao Z, Zhang X, et al., 2022, Processing and Characterization of Crack-free 7075 Aluminum Alloys with Elemental Zr Modification by Laser Powder Bed Fusion. Mater. Sci Addit Manuf, 1:4. http://doi.org/10.18063/msam.v1i1.4
16. Li CH, Wu CH, Lin CL, 2020, Design of a Patient-specific Mandible Reconstruction Implant with Dental Prosthesis for Metal 3D Printing using Integrated Weighted Topology Optimization and Finite Element Analysis. J Mech Behav Biomed Mater, 105:103700. http://doi.org/10.1016/j.jmbbm.2020.103700
17. Arslan AK, Demir T, Ormeci MF, et al., 2013, Postfusion Pullout Strength Comparison of a Novel Pedicle Screw with Classical Pedicle Screws on Synthetic Foams. Proc Inst Mech Eng H, 227:114–9. http://doi.org/10.1177/0954411912463323
18. Hsu JT, Huang HL, Chang CH, et al., 2013, Relationship of Three-dimensional Bone-to-implant Contact to Primary Implant Stability and Peri-implant Bone Strain in Immediate Loading: Microcomputed Tomographic and in vitro Analyses. Int J Oral Maxillofac Implants, 28:367–74. http://doi.org/10.11607/jomi.2407
19. Nagaraja S, Palepu V, 2016, Comparisons of Anterior Plate Screw Pullout Strength between Polyurethane Foams and Thoracolumbar Cadaveric Vertebrae. J Biomech Eng, 1:138. http://doi.org/10.1115/1.4034427
20. Bateman AH, Balkovec C, Akens MK, et al., 2016, Closure of the Annulus Fibrosus of the Intervertebral Disc using a Novel Suture Application Device-in vivo Porcine and ex vivo Biomechanical Evaluation. Spine J, 16:889–95. http://doi.org/10.1016/j.spinee.2016.03.005
21. Burkhart SS, Diaz Pagàn JL, Wirth MA, et al., 1997, Cyclic Loading of Anchor-based Rotator Cuff Repairs: Confirmation of the Tension Overload Phenomenon and Comparison of Suture Anchor Fixation with Transosseous Fixation. Arthroscopy, 13:720–4. http://doi.org/10.1016/s0749-8063(97)90006-2
22. Ikai M, Fukunaga T, 1968, Calculation of Muscle Strength Per Unit Cross-sectional Area of Human Muscle by Means of Ultrasonic Measurement. Int Z Angew Physiol, 26:26–32. http://doi.org/10.1007/bf00696087