Biomechanical assessment of a PEEK rod system for semi-rigid fixation of lumbar fusion constructs

Journal of Biomechanical Engineering

Volumn 133, Issue 8, 2011, Pages

  Gornet, Matthew F ^a   Chan, Frank W ^b   Coleman, John C ^b   Murrell, Brian ^b   Nockels, Russ P ^c   Taylor, Brett A ^a   Lanman, Todd H ^d   Ochoa, Jorge A ^e  

^a Spine Research Center   (United States)

^b Medtronic Spinal Biologics   (United States)

^c LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

^d Exponent Inc ^*  (United States)

^e EXPONENT INC   (United States)

Author keywords

dynamic stabilization; fusion; lumbar; PEEK; polyetheretherketone; semi rigid

Indexed keywords

BENDING TESTS; BIOMECHANICS; BONE; FUSION REACTIONS; PHYSIOLOGY; POLYETHER ETHER KETONES; POLYMERIC IMPLANTS; SCREWS; STABILITY; TITANIUM;

BIOMECHANICAL ASSESSMENT; BIOMECHANICAL PROPERTIES; DYNAMIC STABILIZATION; LUMBAR; PHYSIOLOGICAL LOADINGS; SEMI-RIGID; STATIC AND DYNAMIC PERFORMANCE; STATISTICALLY SIGNIFICANT DIFFERENCE;

DURABILITY;

POLYETHERETHERKETONE; TITANIUM; KETONE; MACROGOL DERIVATIVE;

ANTERIOR POSTERIOR AXIS; ARTHRODESIS; ARTICLE; BIOMECHANICS; CADAVER; CONTROLLED STUDY; EXPERIMENTAL TEST; HUMAN; IN VIVO STUDY; JOINT STABILITY; KINEMATICS; LOAD CARRYING CAPACITY; LUMBAR VERTEBRA; PEDICLE SCREW; PERFORMANCE; RANGE OF MOTION; SEMI RIGID FIXATION; SPINE FUSION; SPINE MOBILITY; SPINE STABILIZATION; BONE SCREW; FINITE ELEMENT ANALYSIS; INSTRUMENTATION; MATERIALS TESTING; MECHANICAL STRESS; METHODOLOGY; REPRODUCIBILITY; SHEAR STRENGTH;

BIOMECHANICS; BONE SCREWS; FINITE ELEMENT ANALYSIS; HUMANS; KETONES; LUMBAR VERTEBRAE; MATERIALS TESTING; POLYETHYLENE GLYCOLS; REPRODUCIBILITY OF RESULTS; SHEAR STRENGTH; SPINAL FUSION; STRESS, MECHANICAL;

EID: 80053221203     PISSN: 01480731     EISSN: 15288951     Source Type: Journal    
DOI: 10.1115/1.4004862     Document Type: Article

References (68)

1. Bono, C. M. and Lee, C. K., 2004, "Critical Analysis of Trends in Fusion for Degenerative Disc Disease Over the Past 20 Years: Influence of Technique on Fusion Rate and Clinical Outcome," Spine, 29(4), pp. 455-463; discussion Z455. (Pubitemid 38209722)
2. Burkus, J. K., Gornet, M. F., Dickman, C. A., and Zdeblick, T. A., 2002, "Anterior Lumbar Interbody Fusion Using Rhbmp-2 With Tapered Interbody Cages," J. Spinal Disord. Tech, 15(5), pp. 337-349.
3. Fritzell, P., Hägg, O., Wessberg, P., and Swedish Lumbar Spine Study Group, 2001, "2001 Volvo Award Winner in Clinical Studies: Lumbar Fusion Versus Nonsurgical Treatment for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial From the Swedish Lumbar Spine Study Group," Spine, 26(23), pp. 2521-2532; discussion 2532-2534.
4. Polly, D. W., Jr., Santos, E. R., and Mehbod, A. A., 2005, "Surgical Treatment for the Painful Motion Segment: Matching Technology With the Indications: Posterior Lumbar Fusion," Spine, 30(16 Suppl), pp. S44-51. (Pubitemid 41208817)
5. Slosar, P. J., 2002, "Indications and Outcomes of Reconstructive Surgery in Chronic Pain of Spinal Origin," Spine, 27(22), pp. 2555-2562; discussion 2563.
6. Zdeblick, T. A., 1995, "The Treatment of Degenerative Lumbar Disorders. A Critical Review of the Literature," Spine, 20(24 Suppl), pp. 126S-137S. (Pubitemid 26011060)
7. Farey, I. D., McAfee, P. C., Gurr, K. R., and Randolph, M. A., 1989, "Quantitative Histologic Study of the Influence of Spinal Instrumentation on Lumbar Fusions: A Canine Model," J. Orthop. Res., 7(5), pp. 709-722. (Pubitemid 19208097)
8. Kanayama, M., Cunningham, B. W., Sefter, J. C., Goldstein, J. A., Stewart, G., Kaneda, K., and McAfee, P. C., 1999, "Does Spinal Instrumentation Influence the Healing Process of Posterolateral Spinal Fusion? An In Vivo Animal Model," Spine, 24(11), pp. 1058-1065. (Pubitemid 29255038)
9. Kotani, Y., Cunningham, B. W., Cappuccino, A., Kaneda, K., and McAfee, P. C., 1996, "The Role of Spinal Instrumentation in Augmenting Lumbar Posterolateral Fusion," Spine, 21(3), pp. 278-287. (Pubitemid 26055967)
10. Lorenz, M., Zindrick, M., Schwaegler, P., Vrbos, L., Collatz, M. A., Behal, R., and Cram, R., 1991, "A Comparison of Single-Level Fusions With and Without Hardware," Spine, 16(8 Suppl), pp. S455-458.
11. Schwab, F. J., Nazarian, D. G., Mahmud, F., and Michelsen, C. B., 1995, "Effects of Spinal Instrumentation on Fusion of the Lumbosacral Spine," Spine, 20(18), pp. 2023-2028.
12. Zdeblick, T. A., 1993, "A Prospective, Randomized Study of Lumbar Fusion. Preliminary Results," Spine, 18(8), pp. 983-991. (Pubitemid 23201484)
13. Martin, B. I., Mirza, S. K., Comstock, B. A., Gray, D. T., Kreuter, W., and Deyo, R. A., 2007, "Are Lumbar Spine Reoperation Rates Falling With Greater Use of Fusion Surgery and New Surgical Technology?," Spine, 32(19), pp. 2119-2126. (Pubitemid 47359619)
14. Bridwell, K. H., Sedgewick, T. A., O'Brien, M. F., Lenke, L. G., and Baldus, C., 1993, "The Role of Fusion and Instrumentation in the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis," J. Spinal Disord., 6(6), pp. 461-472. (Pubitemid 23360532)
15. Mardjetko, S. M., Connolly, P. J., and Shott, S., 1994, "Degenerative Lumbar Spondylolisthesis. A Meta-Analysis of Literature 1970-1993," Spine, 19(20 Suppl), pp. 2256S-2265S. (Pubitemid 24326560)
16. Christensen, F. B., 2004, "Lumbar Spinal Fusion. Outcome in Relation to Surgical Methods, Choice of Implant and Postoperative Rehabilitation," Acta Orthop. Scand. Suppl., 75(313), pp. 2-43.
17. Ebraheim, N. A., Rupp, R. E., Savolaine, E. R., and Reinke, D., 1994, "Use of Titanium Implants in Pedicular Screw Fixation," J. Spinal Disord., 7(6), pp. 478-486. (Pubitemid 24371340)
18. Sagomonyants, K. B., Jarman-Smith, M. L., Devine, J. N., Aronow, M. S., and Gronowicz, G. A., 2008, "The In Vitro Response of Human Osteoblasts to Polyetheretherketone (PEEK) Substrates Compared to Commercially Pure Titanium," Biomaterials, 29(11), pp. 1563-1572.
19. Kurtz, S. M. and Devine, J. N., 2007, "PEEK Biomaterials in Trauma, Orthopedic, and Spinal Implants," Biomaterials, 28(32), pp. 4845-4869. (Pubitemid 47285335)
20. Rho, J. Y., Ashman, R. B., and Turner, C. H., 1993, "Young's Modulus of Trabecular and Cortical Bone Material: Ultrasonic and Microtensile Measurements," J. Biomech., 26(2), pp. 111-119. (Pubitemid 23067441)
21. ASTM International, 2004, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," Subcommittee F04.25 on Spinal Devices, pp. 1-18.
22. Villarraga, M. L., Cripton, P. A., Teti, S. D., Steffey, D. L., Krisnamuthy, S., Albert, T., Hilibrand, A., and Vaccaro, A., 2006, "Wear and Corrosion in Retrieved Thoracolumbar Posterior Internal Fixation," Spine, 31(21), pp. 2454-2462. (Pubitemid 44527028)
23. Bastian, L., Lange, U., Knop, C., Tusch, G., and Blauth, M., 2001, "Evaluation of the Mobility of Adjacent Segments After Posterior Thoracolumbar Fixation: A Biomechanical Study," Eur. Spine J., 10(4), pp. 295-300. (Pubitemid 32762773)
24. Chou, W. Y., Hsu, C. J., Chang, W. N., and Wong, C. Y., 2002, "Adjacent Segment Degeneration After Lumbar Spinal Posterolateral Fusion With Instrumentation in Elderly Patients," Arch. Orthop. Trauma Surg., 122(1), pp. 39-43.
25. Eck, J. C., Humphreys, S. C., and Hodges, S. D., 1999, "Adjacent-Segment Degeneration After Lumbar Fusion: A Review of Clinical, Biomechanical, and Radiologic Studies," Am. J. Orthop., 28(6), pp. 336-340.
26. Lee, C. K., 1988, "Accelerated Degeneration of the Segment Adjacent to a Lumbar Fusion," Spine, 13(3), pp. 375-377.
27. Lehmann, T. R., Spratt, K. F., Tozzi, J. E., Weinstein, J. N., Reinarz, S. J., el- Khoury, G. Y., and Colby, H., 1987, "Long-Term Follow-up of Lower Lumbar Fusion Patients," Spine, 12(2), pp. 97-104. (Pubitemid 17064555)
28. Rahm, M. D. and Hall, B. B., 1996, "Adjacent-Segment Degeneration After Lumbar Fusion With Instrumentation: A Retrospective Study," J. Spinal Disord., 9(5), pp. 392-400. (Pubitemid 26423733)
29. Ahn, Y. H., Chen, W. M., Lee, K. Y., Park, K. W., and Lee, S. J., 2008, "Comparison of the Load-Sharing Characteristics Between Pedicle-Based Dynamic and Rigid Rod Devices," Biomed. Mater., 3(4), p. 44101.
30. Cavagna, R., Tournier, C., Aunoble, S., Bouler, J. M., Antonietti, P., Ronai, M., and Le Huec, J. C., 2008, "Lumbar Decompression and Fusion in Elderly Osteoporotic Patients: A Prospective Study Using Less Rigid Titanium Rod Fixation," J. Spinal Disord. Tech., 21(2), pp. 86-91. (Pubitemid 351507595)
31. Burval, D. J., McLain, R. F., Milks, R., and Inceoglu, S., 2007, "Primary Pedicle Screw Augmentation in Osteoporotic Lumbar Vertebrae: Biomechanical Analysis of Pedicle Fixation Strength," Spine, 32(10), pp. 1077-1083. (Pubitemid 46685984)
32. Xu, H. Z., Wang, X. Y., Chi, Y. L., Zhu, Q. A., Lin, Y., Huang, Q. S., and Dai, L. Y., 2006, "Biomechanical Evaluation of a Dynamic Pedicle Screw Fixation Device," Clin. Biomech. (Bristol, Avon), 21(4), pp. 330-336. (Pubitemid 43276385)
33. Chen, P. Q., Lin, S. J., Wu, S. S., and So, H., 2003, "Mechanical Performance of the New Posterior Spinal Implant: Effect of Materials, Connecting Plate, and Pedicle Screw Design," Spine, 28(9), pp. 881-886; discussion 887. (Pubitemid 36542754)
34. Craven, T. G., Carson, W. L., Asher, M. A., and Robinson, R. G., 1994, "The Effects of Implant Stiffness on the Bypassed Bone Mineral Density and Facet Fusion Stiffness of the Canine Spine," Spine, 19(15), pp. 1664-1673. (Pubitemid 24314172)
35. Cunningham, B. W., Sefter, J. C., Shono, Y., and McAfee, P. C., 1993, "Static and Cyclical Biomechanical Analysis of Pedicle Screw Spinal Constructs," Spine, 18(12), pp. 1677-1688. (Pubitemid 23280317)
36. Johnston, C. E., II, Ashman, R. B., Sherman, M. C., Eberle, C. F., Herndon, W. A., Sullivan, J. A., King, A. G., and Burke, S. W., 1987, "Mechanical Consequences of Rod Contouring and Residual Scoliosis in Sublaminar Segmental Instrumentation," J. Orthop. Res., 5(2), pp. 206-216. (Pubitemid 17088148)
37. Johnston, C. E., II, Welch, R. D., Baker, K. J., and Ashman, R. B., 1995, "Effect of Spinal Construct Stiffness on Short Segment Fusion Mass Incorporation," Spine, 20(22), pp. 2400-2407.
38. Lindsey, C., Deviren, V., Xu, Z., Yeh, R. F., and Puttlitz, C. M., 2006, "The Effects of rod Contouring on Spinal Construct Fatigue Strength," Spine, 31(15), pp. 1680-1687. (Pubitemid 43999965)
39. McAfee, P. C., Farey, I. D., Sutterlin, C. E., Gurr, K. R., Warden, K. E., and Cunningham, B. W., 1991, "The Effect of Spinal Implant Rigidity on Vertebral Bone Density. A Canine Model," Spine, 16(6 Suppl), pp. S190-197.
40. Pienkowski, D., Stephens, G. C., Doers, T. M., and Hamilton, D. M., 1998, "Multicycle Mechanical Performance of Titanium and Stainless Steel Transpedicular Spine Implants," Spine, 23(7), pp. 782-788. (Pubitemid 28169203)
41. Wedemeyer, M., Parent, S., Mahar, A., Odell, T., Swimmer, T., and Newton, P., 2007, "Titanium Versus Stainless Steel for Anterior Spinal Fusions: An Analysis Of Rod Stress as a Predictor of Rod Breakage During Physiologic Loading in a Bovine Model," Spine, 32(1), pp. 42-48. (Pubitemid 46058583)
42. Williams, D., "Polyetheretherketone for Long-Term Implantable Devices," Med. Device Technol., 19(1), pp. 8, 10-11 (2008).
43. Williams, D. F., McNamara, A., and Turner, R. M., 1987, "Potential of Polyetheretherketone (PEEK) and Carbon-Fibre-Reinforced PEEK in Medical Applications," J. Mat. Sci. Lett., 6, pp. 188-190. (Pubitemid 17571474)
44. Ferguson, S. J., Visser, J. M., and Polikeit, A., 2006, "The Long-Term Mechanical Integrity of Non-Reinforced PEEK-OPTIMA Polymer for Demanding Spinal Applications: Experimental and Finite-Element Analysis," Eur. Spine J., 15(2), pp. 149-156.
45. Ponnappan, R. K., Serhan, H., Zarda, B., Patel, R., Albert, T., and Vaccaro, A. R., 2009, "Biomechanical Evaluation and Comparison of Polyetheretherketone Rod System to Traditional Titanium Rod Fixation," Spine J., 9(3), pp. 263-267.
46. Moon, S. M., Ingalhalikar, A., Highsmith, J. M., and Vaccaro, A. R., 2009, "Biomechanical Rigidity of an All-Polyetheretherketone Anterior Thoracolumbar Spinal Reconstruction Construct: An In Vitro Corpectomy Model," Spine J., 9(4), pp. 330-335.
47. ASTM International, 2003, "ASTM F1798-97: Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants."
48. ASTM International, 2004, "ASTM F1717-04: "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
49. Patwardhan, A. G., Havey, R. M., Meade, K. P., Lee, B., and Dunlap, B., 1999, "A Follower Load Increases the Load-Carrying Capacity of the Lumbar Spine in Compression," Spine, 24(10), pp. 1003-1009. (Pubitemid 29222622)
50. Chazal, J., Tanguy, A., Bourges, M., Gaurel, G., Escande, G., Guillot, M., and Vanneuville, G., 1985, "Biomechanical Properties of Spinal Ligaments and a Histological Study of the Supraspinal Ligament in Traction," J. Biomech., 18(3), pp. 167-176. (Pubitemid 15112333)
51. Kumaresan, S., Yoganandan, N., Pintar, F. A., and Maiman, D. J., 1999, "Finite Element Modeling of the Cervical Spine: Role of Intervertebral Disc Under Axial and Eccentric Loads," Med. Eng. Phys., 21(10), pp. 689-700. (Pubitemid 30136350)
52. Little, J. S. and Khalsa, P. S., 2005, "Material Properties of the Human Lumbar Facet Joint Capsule," J. Biomech. Eng., 127(1), pp. 15-24. (Pubitemid 40463477)
53. Morgan, E. F., Bayraktar, H. H., and Keaveny, T. M., 2003, "Trabecular Bone Modulus-Density Relationships Depend on Anatomic Site," J. Biomech., 36(7), pp. 897-904. (Pubitemid 36566627)
54. Polikeit, A., Nolte, L. P., and Ferguson, S. J., 2003, "The Effect of Cement Augmentation on the Load Transfer in an Osteoporotic Functional Spinal Unit: Finite-Element Analysis," Spine, 28(10), pp. 991-996. (Pubitemid 36583327)
55. Silva, M. J., Keaveny, T. M., and Hayes, W. C., 1997, "Load Sharing Between the Shell and Centrum in the Lumbar Vertebral Body," Spine, 22(2), pp. 140-150. (Pubitemid 27081629)
56. Turner, J. L., Paller, D. J., and Murrell, C. B., 2010, "The Mechanical Effect of Commercially Pure Titanium and Polyetheretherketone Rods on Spinal Implants at the Operative and Adjacent Levels," Spine (Phila Pa 1976), 35(21), pp. E1076-1082.
57. Cho, D. Y., Liau, W. R., Lee, W. Y., Liu, J. T., Chiu, C. L., and Sheu, P. C., 2002, "Preliminary Experience Using a Polyetheretherketone (PEEK) Cage in the Treatment of Cervical Disc Disease," Neurosurgery, 51(6), pp. 1343-1349; discussion 1349-1350.
58. Cutler, A. R., Siddiqui, S., Mohan, A. L., Hillard, V. H., Cerabona, F., and Das, K., 2006, "Comparison of Polyetheretherketone Cages With Femoral Cortical Bone Allograft as a single-Piece Interbody Spacer in Transforaminal Lumbar Interbody Fusion," J. Neurosurg. Spine, 5(6), pp. 534-539. (Pubitemid 47325339)
59. Desogus, N., Ennas, F., Leuze, R., and Maleci, A., 2005, "Posterior Lumbar Interbody Fusion With Peek Cages: Personal Experience With 20 Patients," J. Neurosurg. Sci., 49(4), pp. 137-141; discussion 141. (Pubitemid 43139588)
60. Kulkarni, A. G., Hee, H. T., and Wong, H. K., 2007, "Solis Cage (PEEK) for Anterior Cervical Fusion: Preliminary Radiological Results With Emphasis on Fusion and Subsidence," Spine J., 7(2), pp. 205-209.
61. Liao, J. C., Niu, C. C., Chen, W. J., and Chen, L. H., 2008, "Polyetheretherketone (PEEK) Cage Filled With Cancellous Allograft in Anterior Cervical Discectomy and Fusion," Int. Orthop., 32(5), pp. 643-648.
62. Spruit, M., Falk, R. G., Beckmann, L., Steffen, T., and Castelein, R. M., 2005, "The In Vitro Stabilising Effect of Polyetheretherketone Cages Versus a Titanium Cage of Similar Design for Anterior Lumbar Interbody Fusion," Eur. Spine J., 14(8), pp. 752-758. (Pubitemid 41437271)
63. Toth, J. M., Wang, M., Estes, B. T., Scifert, J. L., Seim, H. B., III, and Turner, A. S., 2006, "Polyetheretherketone as a Biomaterial for Spinal Applications," Biomaterials, 27(3), pp. 324-334. (Pubitemid 41457235)
64. Vadapalli, S., Sairyo, K., Goel, V. K., Robon, M., Biyani, A., Khandha, A., and Ebraheim, N. A., 2006, "Biomechanical Rationale for Using Polyetheretherketone (PEEK) Spacers for Lumbar Interbody Fusion-A Finite Element Study," Spine, 31(26), pp. E992-998. (Pubitemid 46005883)
65. Highsmith, J. M., Tumialan, L. M., and Rodts, G. E., Jr., 2007, "Flexible Rods and the Case for Dynamic Stabilization," Neurosurg. Focus, 22(1), p. E11.
66. Bamber, N. I., Zavala I. I. G., and Nockels, R. P., 2008, "Early Single Center Experience Utilizing PEEK Rods for Lumbar Instrumented Fusion," AANS Annual Meeting Chicago, IL., p. Article ID: 49431.
67. Zavala, I. I. G., Bamber, N. I., and Nockels, R. P., 2008, "Clinical Experience with Circumferential PEEK Instrumentation (Interbody and Pedicle Based Rods) in Lumbar Fusion," AANS Annual Meeting Chicago, IL., p. Article ID: 49440.
68. Goel, V. K., Nishiyama, K., Weinstein, J., and Liu Y. K., 1986, "Mechanical Properties of Lumbar Spinal Motion Segments as Affected by Partial Disc Removal," Spine 11, pp. 1008-1012. (Pubitemid 17049556)