Pedicle-Lengthening Osteotomy for the Treatment of Lumbar Spinal Stenosis: Pre-Clinical Study of Novel Orthopedic Devices

The growing number of surgical interventions in patients with spinal degenerative diseases and spinal cord injuries necessitate the development and implementation of innovative technologies for spinal surgery. Successful pre-clinical tests assessing the safety and reliability of the proposed devices are a major step towards further routine use of the novel technologies.

In this report, we describe preclinical studies on screw implants designed to length vertebral pedicles in the lumbar spine and provide indirect decompression of the nerve structures by increasing the transverse size of the spinal canal and intervertebral foramen. The results demonstrated high reliability of the developed device, its potential effectiveness in eliminating lumbar spinal stenosis, and only minor negative effects on the lumbar spine function. Altogether, our study made it possible to start a pilot clinical project on using this technology in patients with symptomatic lumbar spinal stenosis.

1. Global Burden of Disease Study 2013 Collaborators; Vos T., Barber R.M., Bell B., Bertozzi-Villa A., Biryukov S., Bolliger I., Charlson F., Davis A., Degenhardt L., Dicker D., Duan L., Erskine H., Feigin V.L., Ferrari A.J., Fitzmaurice C., Fleming T., Graetz N., Guinovart C., Haagsma J., Hansen G.M., Hanson S.W., Heuton K.R., Higashi H., Kassebaum N., Kyu H., Laurie E., Liang X., Lofgren K., Lozano R., MacIntyre M.F., Moradi-Lakeh M., Naghavi M., Nguyen G., Odell S., Ortblad K., Roberts D.A., Roth G.A., Sandar L., Serina P.T., Stanaway J.D., Steiner C., Thomas B., Vollset S.E., Whiteford H., Wolock T.M., Ye P., Zhou M., Ãvila M.A., Aasvang G.M., Abbafati C., Abbasoglu Ozgoren A., Abd-Allah F., Abdel Aziz M.I., Abera S.F., Aboyans V., Abraham J.P., Abraham B., Abubakar I., Abu-Raddad L.J., Abu-Rmeileh N.M., Aburto T.C., Achoki T., Ackerman I.N., Adelekan A., Ademi Z., Adou A.K., Adsuar J.C., Arnlov J., Agardh E.E., Al Khabouri M.J., Alam S.S., Alasfoor D., Albittar M.I., Alegretti M.A., Aleman A.V., Alemu Z.A., Alfonso-Cristancho R., Alhabib S., Ali R., Alla F., Allebeck P., Allen P.J., AlMazroa M.A., Alsharif U., Alvarez E., Alvis-Guzman N., Ameli O., Amini H., Ammar W., Anderson B.O., Anderson H.R., Antonio C.A., Anwari P., Apfel H., Arsenijevic V.S., Artaman A., Asghar R.J., Assadi R., Atkins L.S., Atkinson C., Badawi A., Bahit M.C., Bakfalouni T., Balakrishnan K., Balalla S., Banerjee A., Barker-Collo S.L., Barquera S., Barregard L., Barrero L.H., Basu S., Basu A., Baxter A., Beardsley J., Bedi N., Beghi E., Bekele T., Bell M.L., Benjet C., Bennett D.A., et al. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 2015; 386(9995): 743–800, https://doi.org/10.1016/s0140-6736(15)60692-4.
2. Deyo R.A., Mirza S.K. Trends and variations in the use of spine surgery. Clin Orthop Relat Res 2006; 443: 139–146.
3. Rajaee S.S., Bae H.W., Kanim L.E., Delamarter R.B. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine 2012; 37(1): 67–76, https://doi.org/10.1097/brs.0b013e31820cccfb.
4. Smith Z.A., Fessler R.G. Paradigm changes in spine surgery — evolution of minimally invasive techniques. Nat Rev Neurol 2012; 8(8): 443–450, https://doi.org/10.1038/nrneurol.2012.110.
5. Spetzger U., Schilling A.V., Winkler G., Wahrburg J., König A. The past, present and future of minimally invasive spine surgery: a review and speculative outlook. Minim Invasive Ther Allied Technol 2013; 22(4): 227–241, https://doi.org/10.3109/13645706.2013.821414.
6. Babu M.A., Heary R.F., Nahed B.V. Device innovation in neurosurgery. Neurosurgery 2012; 70(4):789–795, https://doi.org/10.1227/neu.0b013e318237a68b.
7. Amstutz H.C. Innovations in design and technology. The story of hip arthroplasty. Clin Orthop Relat Res 2000; 378: 23–30.
8. Mlyavykh S., Ludwig S.C., Mobasser J.-P., Kepler C.K., Anderson D.G. Twelve-month results of a clinical pilot study utilizing pedicle-lengthening osteotomy for the treatment of lumbar spinal stenosis. J Neurosurg Spine 2013; 18(4): 347–355, https://doi.org/10.3171/2012.11.spine12402.
9. Kiapour A., Anderson D.G., Spenciner D.B., Ferrara L., Goel V.K. Kinematic effects of a pedicle-lengthening osteotomy for the treatment of lumbar spinal stenosis. J Neurosurg Spine 2012; 17(4): 314–320, https://doi.org/10.3171/2012.6.spine11518.
10. Maisel W.H. Medical device regulation: an introduction for the practicing physician. Ann Intern Med 2004; 140(4): 296, https://doi.org/10.7326/0003-4819-140-4-200402170-00012.
11. Goel V.K., Ferrara L. Basic Science Symposium III: Animal Models for Orthopaedic Implant Evaluation. SAS J 2008; 2(4): 195–200, https://doi.org/10.1016/s1935-9810(08)70039-2.
12. Demir T., Özkaya M. Mechanical testing standards of orthopedic implants. In: Korkusuz F. (editors). Musculoskeletal research and basic science. Springer; 2016; p. 61–91, https://doi.org/10.1007/978-3-319-20777-3_5.
13. Graham J., Estes B.T. What standards can (and can’t) tell us about a spinal device. SAS J 2009; 3(4): 178–183, https://doi.org/10.1016/j.esas.2009.11.001.
14. ASTM F1717-15. Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. ASTM International, West Conshohocken, PA; 2015, https://doi.org/10.1520/f1717-15.
15. ISO 12189:2008. Implants for surgery — Mechanical testing of implantable spinal devices — Fatigue test method for spinal implant assemblies using an anterior support. URL: https://www.iso.org/standard/39288.html.
16. La Barbera L., Galbusera F., Villa T., Costa F., Wilke H.-J. ASTM F1717 standard for the preclinical evaluation of posterior spinal fixators: can we improve it? Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2014; 228(10): 1014–1026, https://doi.org/10.1177/0954411914554244.
17. La Barbera L., Villa T. ISO 12189 standard for the preclinical evaluation of posterior spinal stabilization devices — I: assembly procedure and validation. Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2016; 230(2): 122–133, https://doi.org/10.1177/0954411915621587.
18. Wilke H., Neef P., Caimi M., Hoogland T., Claes L.E. New in vivo measurements of pressures in the intervertebral disc in daily life. Spine 1999; 24(8): 755–762, https://doi.org/10.1097/00007632-199904150-00005.
19. Gonzalez-Blohm S.A., Doulgeris J.J., Lee W.E., Shea T.M., Aghayev K., Vrionis F.D. The current testing protocols for biomechanical evaluation of lumbar spinal implants in laboratory setting: a review of the literature. Biomed Res Int 2015; 2015: 1–15, https://doi.org/10.1155/2015/506181.
20. Panjabi M.M., Brand R.A., White A.A. Three-dimensional flexibility and stiffness properties of the human thoracic spine. J Biomech 1976; 9(4): 185–192, https://doi.org/10.1016/0021-9290(76)90003-8.
21. Panjabi M.M., Kato Y., Hoffman H., Cholewicki J., Krag M. A study of stiffness protocol as exemplified by testing of a burst fracture model in sagittal plane. Spine 2000; 25(21): 2748–2754, https://doi.org/10.1097/00007632-200011010-00006.
22. Panjabi M.M. Hybrid multidirectional test method to evaluate spinal adjacent-level effects. Clin Biomech 2007; 22(3): 257–265, https://doi.org/10.1016/j.clinbiomech.2006.08.006.
23. Goel V.K., Grauer J.N., Patel T.Ch., Biyani A., Sairyo K., Vishnubhotla S., Matyas A., Cowgill I., Shaw M., Long R., Dick D., Panjabi M.M., Serhan H. Effects of Charité artificial disc on the implanted and adjacent spinal segments mechanics using a hybrid testing protocol. Spine 2005; 30(24): 2755–2764, https://doi.org/10.1097/01.brs.0000195897.17277.67.
24. Goel V.K., Winterbottom J.M. Experimental investigation of three-dimensional spine kinetics. Spine 1991; 16(8): 1000–1001, https://doi.org/10.1097/00007632-199108000-00029.
25. Dreischarf M., Shirazi-Adl A., Arjmand N., Rohlmann A., Schmidt H. Estimation of loads on human lumbar spine: a review of in vivo and computational model studies. J Biomech 2016; 49(6): 833–45, https://doi.org/10.1016/j.jbiomech.2015.12.038.
26. Fagan M.J., Julian S., Mohsen A.M. Finite element analysis in spine research. Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2002; 216(5): 281–298, https://doi.org/10.1243/09544110260216568.
27. Jones A.C., Wilcox R.K. Finite element analysis of the spine: towards a framework of verification, validation and sensitivity analysis. Med Eng Phys 2008; 30(10): 1287–1304, https://doi.org/10.1016/j.medengphy.2008.09.006.
28. Dol’ E.S., Ivanov D.V. Modelirovanie poyasnichnogo otdela pozvonochnika metodom konechnykh elementov. V kn.: Prakticheskaya biomekhanika [Modeling of the lumbar spine by the finite element method. In: Practical biomechanics]. Saratov; 2015; p. 11–15.
29. Grauer J.N., Biyani A., Faizan A., Kiapour A., Sairyo K., Ivanov A., Ebraheim N.A., Patel T.Ch., Goel V.K. Biomechanics of two-level Charité artificial disc placement in comparison to fusion plus single-level disc placement combination. Spine J 2006; 6(6): 659–666, https://doi.org/10.1016/j.spinee.2006.03.011.
30. Ivanov A., Kiapour A., Ebraheim N., Goel V.K. Simulation of the transverse fractures of the sacrum using a finite element model of lumbar spine-pelvis segment. ASME 2008 Summer Bioengineering Conference, Parts A and B 2008, https://doi.org/10.1115/sbc2008-193290.
31. Parapalli B. The effects on motion and intra discal pressure after adding a dynamic stabilization device to an injured spine: a finite element based study. In: SAS8, Global Symposium on Motion Preservation Technology. Miami Beach, Florida; 2008; p. 394.
32. Kiapour A., Goel V.K. Biomechanics of a novel lumbar total motion segment preservation system: a computational and in vitro study. Orthoworld 2009; fall 2009: 86–90.

Mlyavykh S.G., Bokov A.E., Yashin K.S., Karyakin N.N., Anderson D.G. Pedicle-Lengthening Osteotomy for the Treatment of Lumbar Spinal Stenosis: Pre-Clinical Study of Novel Orthopedic Devices. Sovremennye tehnologii v medicine 2018; 10(2): 37, https://doi.org/10.17691/stm2018.10.2.04