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Journal of Orthopaedics and Traumatology

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Open Access 01-12-2023 | Silicone | Original article

Bionate^® nucleus disc replacement: bench testing comparing two different designs

Authors: Amparo Vanaclocha, Vicente Vanaclocha, Carlos M. Atienza, Pablo Clavel, Pablo Jordá-Gómez, Carlos Barrios, Leyre Vanaclocha

Published in: Journal of Orthopaedics and Traumatology | Issue 1/2023

Abstract

Background

Intervertebral disc nucleus degeneration initiates a degenerative cascade and can induce chronic low back pain. Nucleus replacement aims to replace the nucleus while the annulus is still intact. Over time, several designs have been introduced, but the definitive solution continues to be elusive. Therefore, we aimed to create a new nucleus replacement that replicates intact intervertebral disc biomechanics, and thus has the potential for clinical applications.

Materials and methods

Two implants with an outer ring and one (D2) with an additional midline strut were compared. Static and fatigue tests were performed with an INSTRON 8874 following the American Society for Testing and Materials F2267-04, F2346-05, 2077-03, D2990-01, and WK4863. Implant stiffness was analyzed at 0–300 N, 500–2000 N, and 2000–6000 N and implant compression at 300 N, 1000 N, 2000 N, and 6000 N. Wear tests were performed following ISO 18192-1:2008 and 18192-2:2010. GNU Octave software was used to calculate movement angles and parameters. The statistical analysis package R was used with the Deducer user interface. Statistically significant differences between the two designs were analyzed with ANOVA, followed by a post hoc analysis.

Results

D1 had better behavior in unconfined compression tests, while D2 showed a “jump.” D2 deformed 1 mm more than D1. Sterilized implants were more rigid and deformed less. Both designs showed similar behavior under confined compression and when adding shear. A silicone annulus minimized differences between the designs. Wear under compression fatigue was negligible for D1 but permanent for D2. D1 suffered permanent height deformation but kept its width. D2 suffered less height loss than D1 but underwent a permanent width deformation. Both designs showed excellent responses to compression fatigue with no breaks, cracks, or delamination. At 10 million cycles, D2 showed 3-times higher wear than D1. D1 had better and more homogeneous behavior, and its wear was relatively low. It showed good mechanical endurance under dynamic loading conditions, with excellent response to axial compression fatigue loading without functional failure after long-term testing.

Conclusion

D1 performed better than D2. Further studies in cadaveric specimens, and eventually in a clinical setting, are recommended.

Level of evidence 2c.

Available only for authorised users

Meucci RD, Fassa AG, Faria NMX (2015) Prevalence of chronic low back pain: systematic review. Rev Saude Publica. https://doi.org/10.1590/S0034-8910.2015049005874CrossRefPubMedPubMedCentral

DePalma MJ, Ketchum JM, Saullo TR, Laplante BL (2012) Is the history of a surgical discectomy related to the source of chronic low back pain? Pain Physician 15:E53-58CrossRefPubMed

Hashimoto K, Aizawa T, Kanno H, Itoi E (2019) Adjacent segment degeneration after fusion spinal surgery—a systematic review. Int Orthop 43:987–993. https://doi.org/10.1007/s00264-018-4241-zCrossRefPubMed

Bateman DK, Millhouse PW, Shahi N et al (2015) Anterior lumbar spine surgery: a systematic review and meta-analysis of associated complications. Spine J Off J North Am Spine Soc 15:1118–1132. https://doi.org/10.1016/j.spinee.2015.02.040CrossRef

Rundell SA, Guerin HL, Auerbach JD, Kurtz SM (2009) Effect of nucleus replacement device properties on lumbar spine mechanics. Spine 34:2022–2032. https://doi.org/10.1097/BRS.0b013e3181af1d5aCrossRefPubMed

Tendulkar G, Chen T, Ehnert S et al (2019) Intervertebral disc nucleus repair: hype or hope? Int J Mol Sci. https://doi.org/10.3390/ijms20153622CrossRefPubMedPubMedCentral

Nic An Ghaill N, Little EG (2008) Determination of the mechanical properties of Bionate 80A and Bionate 75D for the stress analysis of cushion form bearings. Proc Inst Mech Eng 222:683–694. https://doi.org/10.1243/09544119JEIM372CrossRef

White AA, Panjabi MM (1990) Clinical biomechanics of the spine, 2nd edn. Lippincott, Philadelphia

Coogan JS, Francis WL, Eliason TD et al (2016) Finite element study of a lumbar intervertebral disc nucleus replacement device. Front Bioeng Biotechnol 4:93. https://doi.org/10.3389/fbioe.2016.00093CrossRefPubMedPubMedCentral

10.

Kulak RF, Belytschko TB, Schultz AB (1976) Nonlinear behavior of the human intervertebral disc under axial load. J Biomech 9:377–386. https://doi.org/10.1016/0021-9290(76)90115-9CrossRefPubMed

11.

Wilke HJ, Neef P, Caimi M et al (1999) New in vivo measurements of pressures in the intervertebral disc in daily life. Spine 24:755–762. https://doi.org/10.1097/00007632-199904150-00005CrossRefPubMed

12.

Sato K, Kikuchi S, Yonezawa T (1999) In vivo intradiscal pressure measurement in healthy individuals and patients with ongoing back problems. Spine 24:2468–2474. https://doi.org/10.1097/00007632-199912010-00008CrossRefPubMed

13.

Bazrgari B, Shirazi-Adl A, Arjmand N (2007) Analysis of squat and stoop dynamic liftings: muscle forces and internal spinal loads. Eur Spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc 16:687–699. https://doi.org/10.1007/s00586-006-0240-7CrossRef

14.

Khoo BC, Goh JC, Bose K (1995) A biomechanical model to determine lumbosacral loads during single stance phase in normal gait. Med Eng Phys 17:27–35. https://doi.org/10.1016/1350-4533(95)90374-kCrossRefPubMed

15.

Scholes SC, Joyce TJ (2013) In vitro tests of substitute lubricants for wear testing orthopaedic biomaterials. Proc Inst Mech Eng H 227:693–703. https://doi.org/10.1177/0954411913481549CrossRefPubMed

16.

Kirby KN, Gerlanc D (2013) BootES: an R package for bootstrap confidence intervals on effect sizes. Behav Res Methods 45:905–927. https://doi.org/10.3758/s13428-013-0330-5CrossRefPubMed

17.

R: The R project for statistical computing. https://www.r-project.org/. Accessed 1 Apr 2016

18.

Markolf KL, Morris JM (1974) The structural components of the intervertebral disc. A study of their contributions to the ability of the disc to withstand compressive forces. J Bone Joint Surg Am 56:675–687CrossRefPubMed

19.

Grupp TM, Yue JJ, Garcia R et al (2009) Biotribological evaluation of artificial disc arthroplasty devices: influence of loading and kinematic patterns during in vitro wear simulation. Eur Spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc 18:98–108. https://doi.org/10.1007/s00586-008-0840-5CrossRef

20.

Lee JL, Billi F, Sangiorgio SN et al (2008) Wear of an experimental metal-on-metal artificial disc for the lumbar spine. Spine 33:597–606. https://doi.org/10.1097/BRS.0b013e318166aaa4CrossRefPubMed

21.

Hellier WG, Hedman TP, Kostuik JP (1992) Wear studies for development of an intervertebral disc prosthesis. Spine 17:S86-96. https://doi.org/10.1097/00007632-199206001-00005CrossRefPubMed

22.

Zengerle L, Köhler A, Debout E et al (2020) Nucleus replacement could get a new chance with annulus closure. Eur Spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc 29:1733–1741. https://doi.org/10.1007/s00586-020-06419-2CrossRef

23.

Berlemann U, Schwarzenbach O (2009) An injectable nucleus replacement as an adjunct to microdiscectomy: 2-year follow-up in a pilot clinical study. Eur Spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc 18:1706–1712. https://doi.org/10.1007/s00586-009-1136-0CrossRef

24.

Selviaridis P, Foroglou N, Tsitlakidis A et al (2010) Long-term outcome after implantation of prosthetic disc nucleus device (PDN) in lumbar disc disease. Hippokratia 14:176–184PubMedPubMedCentral

25.

Dahl MC, Ahrens M, Sherman JE, Martz EO (2010) The restoration of lumbar intervertebral disc load distribution: a comparison of three nucleus replacement technologies. Spine 35:1445–1453. https://doi.org/10.1097/BRS.0b013e3181bef192CrossRefPubMed

26.

Joshi A, Mehta S, Vresilovic E et al (2005) Nucleus implant parameters significantly change the compressive stiffness of the human lumbar intervertebral disc. J Biomech Eng 127:536–540. https://doi.org/10.1115/1.1894369CrossRefPubMed

27.

Li Z, Lang G, Chen X et al (2016) Polyurethane scaffold with in situ swelling capacity for nucleus pulposus replacement. Biomaterials 84:196–209. https://doi.org/10.1016/j.biomaterials.2016.01.040CrossRefPubMed

28.

Malhotra NR, Han WM, Beckstein J et al (2012) An injectable nucleus pulposus implant restores compressive range of motion in the ovine disc. Spine 37:E1099-1105. https://doi.org/10.1097/BRS.0b013e31825cdfb7CrossRefPubMedPubMedCentral

29.

Gonzalez Alvarez A, Dearn KD, Shepherd DET (2019) Design and material evaluation for a novel lumbar disc replacement implanted via unilateral transforaminal approach. J Mech Behav Biomed Mater 91:383–390. https://doi.org/10.1016/j.jmbbm.2018.12.011CrossRefPubMed

30.

Szelest-Lewandowska A, Masiulanis B, Szymonowicz M et al (2007) Modified polycarbonate urethane: synthesis, properties and biological investigation in vitro. J Biomed Mater Res A 82:509–520. https://doi.org/10.1002/jbm.a.31357CrossRefPubMed

31.

Lin HA, Varma DM, Hom WW et al (2019) Injectable cellulose-based hydrogels as nucleus pulposus replacements: assessment of in vitro structural stability, ex vivo herniation risk, and in vivo biocompatibility. J Mech Behav Biomed Mater 96:204–213. https://doi.org/10.1016/j.jmbbm.2019.04.021CrossRefPubMedPubMedCentral

32.

Khandaker M, Riahanizad S (2017) Evaluation of electrospun nanofiber-anchored silicone for the degenerative intervertebral disc. J Healthc Eng 2017:5283846. https://doi.org/10.1155/2017/5283846CrossRefPubMedPubMedCentral

33.

Schmocker A, Khoushabi A, Frauchiger DA et al (2016) A photopolymerized composite hydrogel and surgical implanting tool for a nucleus pulposus replacement. Biomaterials 88:110–119. https://doi.org/10.1016/j.biomaterials.2016.02.015CrossRefPubMed

34.

Feng G, Zhang Z, Jin X et al (2012) Regenerating nucleus pulposus of the intervertebral disc using biodegradable nanofibrous polymer scaffolds. Tissue Eng Part A 18:2231–2238. https://doi.org/10.1089/ten.TEA.2011.0747CrossRefPubMedPubMedCentral

35.

Leone G, Torricelli P, Chiumiento A et al (2008) Amidic alginate hydrogel for nucleus pulposus replacement. J Biomed Mater Res A 84:391–401. https://doi.org/10.1002/jbm.a.31334CrossRefPubMed

36.

Di Martino A, Vaccaro AR, Lee JY et al (2005) Nucleus pulposus replacement: basic science and indications for clinical use. Spine 30:S16-22. https://doi.org/10.1097/01.brs.0000174530.88585.32CrossRefPubMed

37.

Briski DC, Goel VK, Waddell BS et al (2017) Does spanning a lateral lumbar interbody cage across the vertebral ring apophysis increase loads required for failure and mitigate endplate violation. Spine 42:E1158–E1164. https://doi.org/10.1097/BRS.0000000000002158CrossRefPubMed

38.

Simmons A, Hyvarinen J, Odell RA et al (2004) Long-term in vivo biostability of poly(dimethylsiloxane)/poly(hexamethylene oxide) mixed macrodiol-based polyurethane elastomers. Biomaterials 25:4887–4900. https://doi.org/10.1016/j.biomaterials.2004.01.004CrossRefPubMed

39.

Heuer F, Ulrich S, Claes L, Wilke H-J (2008) Biomechanical evaluation of conventional anulus fibrosus closure methods required for nucleus replacement. Lab Investig J Neurosurg Spine 9:307–313. https://doi.org/10.3171/SPI/2008/9/9/307CrossRef

Title: Bionate® nucleus disc replacement: bench testing comparing two different designs
Authors: Amparo Vanaclocha
Vicente Vanaclocha
Carlos M. Atienza
Pablo Clavel
Pablo Jordá-Gómez
Carlos Barrios
Leyre Vanaclocha
Publication date: 01-12-2023
Publisher: Springer International Publishing
Keywords: Silicone
Fatigue
Published in: Journal of Orthopaedics and Traumatology / Issue 1/2023
Print ISSN: 1590-9921
Electronic ISSN: 1590-9999
DOI: https://doi.org/10.1186/s10195-023-00692-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Bionate^® nucleus disc replacement: bench testing comparing two different designs

Abstract

Background

Materials and methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Materials and methods

Results

Conclusion

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