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Erschienen in: European Spine Journal 1/2017

16.09.2016 | Original Article

Preclinical evaluation of posterior spine stabilization devices: can we compare in vitro and in vivo loads on the instrumentation?

verfasst von: Luigi La Barbera, Fabio Galbusera, Hans-Joachim Wilke, Tomaso Villa

Erschienen in: European Spine Journal | Ausgabe 1/2017

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Abstract

Purpose

To discuss whether the standard test method for preclinical evaluation of posterior spine stabilization devices with an anterior support correctly describes the effect of two short-segment posterior stabilization techniques frequently used in clinical practice for the treatment of traumatic, degenerative and iatrogenic instabilities.

Methods

A finite element study compared a validated instrumented L2–L4 segment undergoing standing, upper body flexion and extension to ISO 12189 standards model under a compressive load. A bridge instrumentation, with screws only at cranial and caudal levels, and a full stabilization, using screws at every level, are considered for both conditions. The internal loads on the spinal rod and the stress values on the implant are analysed in detail.

Results

Using ISO model and a bridge stabilization construct allow to overstress the pedicle screw more than a full stabilization with respect to the corresponding L2–L4 segment undergoing upper body flexion, while the stress on the spinal rod is comparable. Choosing softer/stiffer springs would involve higher/lower loads on every component.

Conclusions

ISO model predicts the effects of using both a full and a bridge posterior instrumentation. The study justifies the use of both conditions during in vitro reliability tests to achieve meaningful results easy to compare to clinically relevant loading modes and known in vivo failure modes.
Literatur
1.
2.
Zurück zum Zitat ISO Standard (2008) 12189: Implants for surgery—mechanical testing of implantable spinal devices—fatigue test method for spinal implant assemblies using an anterior support ISO Standard (2008) 12189: Implants for surgery—mechanical testing of implantable spinal devices—fatigue test method for spinal implant assemblies using an anterior support
3.
Zurück zum Zitat La Barbera L, Galbusera F, Wilke H-J, Villa T (2016) Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities? Eur Spine J. doi:10.1007/s00586-016-4622-1 La Barbera L, Galbusera F, Wilke H-J, Villa T (2016) Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities? Eur Spine J. doi:10.​1007/​s00586-016-4622-1
4.
Zurück zum Zitat Carson W, Asher M, Boachie-Adjei O, Akbarnia B, Dzioba R, Lebwohl N (2003) History of isola-vsp fatigue testing results with correlation to clinical implant failures. In: Melkerson M, Griffith S, Kirkpatrick J (eds) Spinal implants: are we evaluating them appropriately? STP 1431:3–16. ASTM International Carson W, Asher M, Boachie-Adjei O, Akbarnia B, Dzioba R, Lebwohl N (2003) History of isola-vsp fatigue testing results with correlation to clinical implant failures. In: Melkerson M, Griffith S, Kirkpatrick J (eds) Spinal implants: are we evaluating them appropriately? STP 1431:3–16. ASTM International
5.
Zurück zum Zitat Cunningham BW, Sefter JC, Shono Y, McAfee PC (1993) Static and cyclical biomechanical analysis of pedicle screw spinal constructs. Spine 18(12):1677–1688CrossRefPubMed Cunningham BW, Sefter JC, Shono Y, McAfee PC (1993) Static and cyclical biomechanical analysis of pedicle screw spinal constructs. Spine 18(12):1677–1688CrossRefPubMed
6.
Zurück zum Zitat La Barbera L, Costa F, Villa T (2016) ISO 12189 standard for the preclinical evaluation of posterior spinal stabilization devices—II: a parametric comparative study. Proc Inst Mech Eng H 230(2):134–144. doi:10.1177/0954411915621588 CrossRefPubMed La Barbera L, Costa F, Villa T (2016) ISO 12189 standard for the preclinical evaluation of posterior spinal stabilization devices—II: a parametric comparative study. Proc Inst Mech Eng H 230(2):134–144. doi:10.​1177/​0954411915621588​ CrossRefPubMed
7.
9.
11.
Zurück zum Zitat Chamoli U, Diwan AD (2014) Tsafnat N Pedicle screw-based posterior dynamic stabilizers for degenerative spine: in vitro biomechanical testing and clinical outcomes. J Biomed Mater Res A (US) 102(9):p3324–p3340CrossRef Chamoli U, Diwan AD (2014) Tsafnat N Pedicle screw-based posterior dynamic stabilizers for degenerative spine: in vitro biomechanical testing and clinical outcomes. J Biomed Mater Res A (US) 102(9):p3324–p3340CrossRef
12.
Zurück zum Zitat Smith JS, Shaffrey CI, Ames CP, Demakakos J, Fu KM, Keshavarzi S, Li CM, Deviren V, Schwab FJ, Lafage V, Bess S (2012) Assessment of symptomatic rod fracture after posterior instrumented fusion for adult spinal deformity. Neurosurgery 71(4):862–867CrossRefPubMed Smith JS, Shaffrey CI, Ames CP, Demakakos J, Fu KM, Keshavarzi S, Li CM, Deviren V, Schwab FJ, Lafage V, Bess S (2012) Assessment of symptomatic rod fracture after posterior instrumented fusion for adult spinal deformity. Neurosurgery 71(4):862–867CrossRefPubMed
14.
Zurück zum Zitat Sapkas G, Kateros K, Papadakis SA, Brilakis E, Macheras G, Katonis P (2010) Treatment of unstable thoracolumbar burst fractures by indirect reduction and posterior stabilization: short-segment versus long-segment stabilization. Open Orthop J 15(4):7–13. doi:10.2174/1874325001004010007 CrossRef Sapkas G, Kateros K, Papadakis SA, Brilakis E, Macheras G, Katonis P (2010) Treatment of unstable thoracolumbar burst fractures by indirect reduction and posterior stabilization: short-segment versus long-segment stabilization. Open Orthop J 15(4):7–13. doi:10.​2174/​1874325001004010​007 CrossRef
15.
Zurück zum Zitat Hwang JH, Modi HN, Yang JH, Kim SJ, Lee SH (2009) Short segment pedicle screw fixation for unstable T11-L2 fractures: with or without fusion? A three-year follow-up study. Acta Orthop Belg 75(6):822–827PubMed Hwang JH, Modi HN, Yang JH, Kim SJ, Lee SH (2009) Short segment pedicle screw fixation for unstable T11-L2 fractures: with or without fusion? A three-year follow-up study. Acta Orthop Belg 75(6):822–827PubMed
16.
Zurück zum Zitat Korovessis P, Papazisis Z, Koureas G, Lambiris E (2004) Rigid, semirigid versus dynamic instrumentation for degenerative lumbar spinal stenosis: a correlative radiological and clinical analysis of short-term results. Spine (Phila Pa 1976) 29(7):735–742CrossRef Korovessis P, Papazisis Z, Koureas G, Lambiris E (2004) Rigid, semirigid versus dynamic instrumentation for degenerative lumbar spinal stenosis: a correlative radiological and clinical analysis of short-term results. Spine (Phila Pa 1976) 29(7):735–742CrossRef
17.
Zurück zum Zitat Farrokhi MR, Razmkon A, Maghami Z, Nikoo Z (2010) Inclusion of the fracture level in short segment fixation of thoracolumbar fractures. Eur Spine J 2010(19):1651–1656CrossRef Farrokhi MR, Razmkon A, Maghami Z, Nikoo Z (2010) Inclusion of the fracture level in short segment fixation of thoracolumbar fractures. Eur Spine J 2010(19):1651–1656CrossRef
18.
Zurück zum Zitat Chen CS, Chen WJ, Cheng CK, Jao SH, Chueh SC, Wang CC (2005) Failure analysis of broken pedicle screws on spinal instrumentation. Med EngPhys 27(6):487–496CrossRef Chen CS, Chen WJ, Cheng CK, Jao SH, Chueh SC, Wang CC (2005) Failure analysis of broken pedicle screws on spinal instrumentation. Med EngPhys 27(6):487–496CrossRef
19.
Zurück zum Zitat Jutte PC, Castelein RM (2002) Complications of pedicle screws in lumbar and lumbosacral fusions in 105 consecutive primary operations. Eur Spine J 2002(11):594–598CrossRef Jutte PC, Castelein RM (2002) Complications of pedicle screws in lumbar and lumbosacral fusions in 105 consecutive primary operations. Eur Spine J 2002(11):594–598CrossRef
20.
Zurück zum Zitat Pihlajämaki H, Myllynen P, Böstman O (1997) Complications of transpedicular lumbosacral fixation for non-traumatic disorders. J Bone Joint Surg Br 79(2):183–189CrossRefPubMed Pihlajämaki H, Myllynen P, Böstman O (1997) Complications of transpedicular lumbosacral fixation for non-traumatic disorders. J Bone Joint Surg Br 79(2):183–189CrossRefPubMed
21.
22.
Zurück zum Zitat McCormack T, Karaikovic E, Gaines RW (1994) The load sharing classification of spine fractures. Spine 19(15):1741–1744CrossRefPubMed McCormack T, Karaikovic E, Gaines RW (1994) The load sharing classification of spine fractures. Spine 19(15):1741–1744CrossRefPubMed
23.
Zurück zum Zitat Magerl F, Aebi M, Gertzbein SD, Harms J, Nazarian S (1994) A comprehensive classification of thoracic and lumbar injuries. Eur Spine J 3(4):184–201CrossRefPubMed Magerl F, Aebi M, Gertzbein SD, Harms J, Nazarian S (1994) A comprehensive classification of thoracic and lumbar injuries. Eur Spine J 3(4):184–201CrossRefPubMed
24.
Zurück zum Zitat Carl AL, Tromanhauser SG, Roger DJ (1992) Pedicle screw instrumentation for thoracolumbar burst fractures and fracture-dislocations. A calf spine model. Spine 17:317–324CrossRef Carl AL, Tromanhauser SG, Roger DJ (1992) Pedicle screw instrumentation for thoracolumbar burst fractures and fracture-dislocations. A calf spine model. Spine 17:317–324CrossRef
27.
Zurück zum Zitat Tian JW, Wang L, Xia T, Liu CY, Zhao QH, Dong SH (2011) Posterior short-segmental fixation combined with intermediate screws vs. conventional intersegmental fixation for monosegmental thoracolumbar fractures. Orthopedics 34(8):e389–e396. doi:10.3928/01477447-20110627-08 PubMed Tian JW, Wang L, Xia T, Liu CY, Zhao QH, Dong SH (2011) Posterior short-segmental fixation combined with intermediate screws vs. conventional intersegmental fixation for monosegmental thoracolumbar fractures. Orthopedics 34(8):e389–e396. doi:10.​3928/​01477447-20110627-08 PubMed
29.
Zurück zum Zitat Rohlmann A, Bergmann G, Graichen F, Weber U (1997) Comparison of loads on internal spinal fixation devices measured in vitro and in vivo. Med Eng Phys 19(6):539–546CrossRefPubMed Rohlmann A, Bergmann G, Graichen F, Weber U (1997) Comparison of loads on internal spinal fixation devices measured in vitro and in vivo. Med Eng Phys 19(6):539–546CrossRefPubMed
30.
Zurück zum Zitat Wilke HJ, Rohlmann A, Neller S, Schultheiss M, Bergmann G, Graichen F, Claes L (2001) Is it possible to simulate physiologic loading conditions by applying pure moments? a comparison of in vivo and in vitro load components in an internal fixator. Spine 26(6):636–642CrossRefPubMed Wilke HJ, Rohlmann A, Neller S, Schultheiss M, Bergmann G, Graichen F, Claes L (2001) Is it possible to simulate physiologic loading conditions by applying pure moments? a comparison of in vivo and in vitro load components in an internal fixator. Spine 26(6):636–642CrossRefPubMed
31.
34.
Zurück zum Zitat Rohlmann A, Bergmann G, Graichen F (1999) Loads on internal spinal fixators measured in different body positions. Europ Spine J 8(5):354–359CrossRef Rohlmann A, Bergmann G, Graichen F (1999) Loads on internal spinal fixators measured in different body positions. Europ Spine J 8(5):354–359CrossRef
35.
Zurück zum Zitat ISO Standard (2010) 10243: Tools for pressing—compression springs with rectangular section—housing dimensions and colour coding ISO Standard (2010) 10243: Tools for pressing—compression springs with rectangular section—housing dimensions and colour coding
36.
Zurück zum Zitat Wu ZX, Zhan C, Cui G, Liu D, Wan SY, Zhang Y, Zhao X, Lei W (2012) Stress distribution on the screws in posterior lumbar fusion of isthmic spondylolisthesis with 2- or 3-vertebra fixation techniques: a biomechanical cadaveric study. J Surg Res 176(1):95–101. doi:10.1016/j.jss.2011.05.004 CrossRefPubMed Wu ZX, Zhan C, Cui G, Liu D, Wan SY, Zhang Y, Zhao X, Lei W (2012) Stress distribution on the screws in posterior lumbar fusion of isthmic spondylolisthesis with 2- or 3-vertebra fixation techniques: a biomechanical cadaveric study. J Surg Res 176(1):95–101. doi:10.​1016/​j.​jss.​2011.​05.​004 CrossRefPubMed
37.
Zurück zum Zitat Rohlmann A, Consmuller T, Dreischarf M, Bashkuev M, Disch A, Pries E, Duda GN, Schmidt H (2014) Measurement of the number of lumbar spinal movements in the sagittal plane in a 24-h period. Eur Spine J (Germany) 23(11):2375–2384. doi:10.1007/s00586-014-3588-0 CrossRef Rohlmann A, Consmuller T, Dreischarf M, Bashkuev M, Disch A, Pries E, Duda GN, Schmidt H (2014) Measurement of the number of lumbar spinal movements in the sagittal plane in a 24-h period. Eur Spine J (Germany) 23(11):2375–2384. doi:10.​1007/​s00586-014-3588-0 CrossRef
Metadaten
Titel
Preclinical evaluation of posterior spine stabilization devices: can we compare in vitro and in vivo loads on the instrumentation?
verfasst von
Luigi La Barbera
Fabio Galbusera
Hans-Joachim Wilke
Tomaso Villa
Publikationsdatum
16.09.2016
Verlag
Springer Berlin Heidelberg
Erschienen in
European Spine Journal / Ausgabe 1/2017
Print ISSN: 0940-6719
Elektronische ISSN: 1432-0932
DOI
https://doi.org/10.1007/s00586-016-4766-z

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