Resultados funcionales y dolor en pacientes intervenidos con sistemas de estabilización dinámica interespinosa frente a artrodesis intervertebral

Resumo

Motivación de la tesis: Analizar si la adición de un espaciador interespinoso o la fusión intersomática ofrece ventajas en relación con la microdiscetomía aislada en el tratamiento de la hernia discal lumbar. Desarrollo teórico: Pacientes con hernia de disco lumbar que iban a someterse a cirugía fueron elegidos para participar. En este estudio de cohorte los pacientes se dividieron en 3 grupos; Microdiscectomía sola (MD), microdiscectomía más espaciador interespinoso (IS) y fusión intersomática lumbar posterior (PLIF). La medida de resultado primaria fue la eficacia clínica mediante el índice de discapacidad de Oswestry (ODI). También evaluamos varios otros parámetros de resultado, entre los que se incluyeron: escala analógica visual para el dolor (EVA) de espalda y piernas, duración de la estancia, coste desde el ingreso hasta el alta hospitalaria, tasa de complicaciones de 90 días y tasa de reoperación tras 1 año. Se incluyeron un total de 103 pacientes cuya edad media fue de 39,1 (± 8,5) años. En los 3 grupos se detectó una mejora significativa de la puntuación inicial del dolor de espalda y piernas con ODI y EVA. Las puntuaciones del ODI cambiaron de 62.66 a 13.77 en el grupo MD, 62.93 a 13.50 en el grupo IS, y 59.62 a 17.62 en el grupo PLIF (p <0.001). Después de 1 año, no se encontraron diferencias significativas en el ODI, ni en la EVA de espalda y piernas entre los 3 grupos. Hubo un aumento del 169% en el coste hospitalario en el grupo IS y del 287% en el grupo PLIF, en relación con la MD (p <0,001). La duración de la estancia fue un 86% mayor en el grupo IS y un 384% más en el grupo PLIF en comparación con MD (p <0,001). Las tasas de reoperación a 1 año fueron de 5,6%, 10% y 16,2% (p = 0,33) en los grupos MD, IS y PLIF respectivamente. Conclusión: La mejoría clínica parece deberse a la microdiscectomía, sin que el implante (interespinoso o fusión) agregue ningún beneficio. La adición de espaciador interespinoso o fusión no protegió contra la reoperación, y aumentó la duración de la estancia hospitalaria y los gastos quirúrgicos. Bibliografía consultada: 1. Raj PP. Intervertebral disc: anatomy-physiology-pathophysiology-treatment. Pain Pract. 2008 Jan-Feb;8(1):18-44. doi: 10.1111/j.1533-2500.2007.00171. 2. Roberts S, Menage J, Urban JP. Biochemical and structural properties of the cartilage end-plate and its relation to the intervertebral disc. Spine (Phila Pa 1976). 1989 Feb;14(2):166-74. 3. Roberts S, Evans H, Trivedi J, Menage J. Histology and pathology of the human intervertebral disc. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:10-4. 4. Inoue H. Three-dimensional architecture of lumbar intervertebral discs. Spine (Phila Pa 1976). 1981 Mar-Apr;6(2):139-46. 5. Marchand F, Ahmed AM. Investigation of the laminate structure of lumbar disc anulus fibrosus. Spine (Phila Pa 1976). 1990 May;15(5):402-10. 6. Eyre DR, Muir H. Types I and II collagens in intervertebral disc. Interchanging radial distributions in annulus fibrosus. Biochem J. 1976 Jul 1;157(1):267-70. 7. Yu J, Winlove PC, Roberts S, Urban JP. Elastic fibre organization in the intervertebral discs of the bovine tail. J Anat. 2002 Dec;201(6):465-75. 8. Eyre DR, Muir H. Quantitative analysis of types I and II collagens in the human intervertebral disc at various ages. Biochimica Biophysica Acta. 1977;492:29–42. 9. Urban JP, Maroudas A, Bayliss MT, Dillon J. Swelling pressures of proteoglycans at the concentrations found in cartilaginous tissues. Biorheology. 1979;16:447–464. 10. Buckwalter JA. Aging and degeneration of the human intervertebral disc. Spine. 1995;20:1307–1314. 11. Roberts S, Eisenstein SM, Menage J, Evans EH, Ashton IK. Mechanoreceptors in intervertebral discs. Morphology, distribution, and neuropeptides. Spine. 1995;20: 2645–2651. 12. Lyons G, Eisenstein SM, Sweet MB. Biochemical changes in intervertebral disc degeneration. Biochim Biophys Acta. 1981;673:443–453. 13. Frobin W, Brinckmann P, Kramer M, Hartwig E. Height of lumbar discs measured from radiographs compared with degeneration and height classified from MR images. Eur Radiol. 2001;11:263–269. 14. Mysliwiec LW, Cholewicki J, Winkelpleck MD, Eis GP. MSU classification for herniated lumbar discs on MRI: toward developing objective criteria for surgical selection. Eur Spine J. 2010;19(7):1087-93. 15. Jordan J, Konstantinou K, O'Dowd J. Herniated lumbar disc. BMJ Clin Evid. 2009 Mar 26;2009. 16. Heliövaara M, Knekt P, Aromaa A.Incidence and risk factors of herniated lumbar intervertebral disc or sciatica leading to hospitalization. J Chronic Dis 1987; 40:251-8. 17. Tullberg T, Isacson J, Weidenhielm L. Does microscopic removal of lumbar disc herniation lead to better results than the standard procedure? Results of a one-year randomized study. Spine (Phila Pa 1976). 1993 Jan;18(1):24-7. 18. McGirt MJ, Ambrossi GL, Datoo G, Sciubba DM, Witham TF, Wolinsky JP, Gokaslan ZL, Bydon A. Recurrent disc herniation and long-term back pain after primary lumbar discectomy: review of outcomes reported for limited versus aggressive disc removal. Neurosurgery. 2009 Feb;64(2):338-44; discussion 344-5. doi:10.1227/01.NEU.0000337574.58662.E2. 19. Galarza M, Gazzeri R, De la Rosa P, Martínez-Lage JF. Microdiscectomy with and without insertion of interspinous device for herniated disc at the L5-S1 level. J Clin Neurosci 2014;21(11):1934-9. 20. Arrotegui I. Coflex interspinous spacer. Use in degenerative lumbar disc herniation. Acta Ortop Mex. 2010 May-Jun;24(3):187-90. 21. Wilke HJ, Drumm J, Häussler K, Mack C, Steudel WI, Kettler A. Biomechanical effect of different lumbar interspinous implants on flexibility and intradiscal pressure. Eur Spine J. 2008 Aug;17(8):1049-56. doi: 10.1007/s00586-008-0657-2. Epub 2008 Jun 27. 22. Satoh I, Yonenobu K, Hosono N, Ohwada T, Fuji T, Yoshikawa H. Indication of posterior lumbar interbody fusion for lumbar disc herniation. J Spinal Disord Tech. 2006 Apr;19(2):104-8. 23. Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50 24. Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States' trends and regional variations in lumbar spine surgery: 1992-2003. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2707-14. 25. Aizawa T, Kokubun S, Ozawa H, Kusakabe T, Tanaka Y, Hoshikawa T, Hashimoto K, Kanno H, Morozumi N, Koizumi Y, Sato T, Hyodo H, Kasama F, Ogawa S, Murakami E,Kawahara C, Yahata J, Ishii Y, Itoi E. Increasing Incidence of Degenerative Spinal Diseases in Japan during 25 Years: The Registration System of Spinal Surgery in Tohoku University Spine Society. Tohoku J Exp Med. 2016 Feb;238(2):153-63. doi: 10.1620/tjem.238.153. 26. Rasouli MR, Rahimi-Movaghar V, Shokraneh F, Moradi-Lakeh M, Chou R. Minimally invasive discectomy versus microdiscectomy/open discectomy for symptomatic lumbar disc herniation. Cochrane Database Syst Rev. 2014 Sep 4;(9):CD010328. doi:10.1002/14651858.CD010328 27. Parker SL, Mendenhall SK, Godil SS, Sivasubramanian P, Cahill K, Ziewacz J,McGirt MJ. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015 Jun;473(6):1988-99. doi: 10.1007/s11999-015-4193-1. 28. Heindel P, Tuchman A, Hsieh PC, Pham MH, D'Oro A, Patel NN, Jakoi AM, Hah R,Liu JC, Buser Z, Wang JC. Reoperation Rates After Single-level Lumbar Discectomy.Spine (Phila Pa 1976). 2017 Apr 15;42(8):E496-E501. doi:10.1097/BRS.0000000000001855. 29. Osterman H, Sund R, Seitsalo S, Keskimäki I. Risk of multiple reoperations after lumbar discectomy: a population-based study. Spine (Phila Pa 1976). 2003 Mar 15;28(6):621-7. 30. Xu D, Xu HZ, Chen YH, Chi YL, Ni WF, Huang QS, Wang XY, Lin Y, Mao FM.Discectomy and discectomy plus Coflex fixation for lumbar disc herniation, a clinical comparison study. Zhonghua Wai Ke Za Zhi. 2013 Feb 1;51(2):147-51. 31. Arrotegui I. [Using a new implant: U-Force N6 to level L5 S1 to avoid lumbar instability after single discectomy]. Acta Ortop Mex. 2015 Nov-Dec;29(6):309-12. 32. Floman Y, Millgram MA, Smorgick Y, Rand N, Ashkenazi E. Failure of the Wallis interspinous implant to lower the incidence of recurrent lumbar disc herniations in patients undergoing primary disc excision. J Spinal Disord Tech. 2007 Jul;20(5):337-41. 33. Satoh I, Yonenobu K, Hosono N, Ohwada T, Fuji T, Yoshikawa H. Indication of posterior lumbar interbody fusion for lumbar disc herniation. J Spinal Disord Tech. 2006 Apr;19(2):104-8. 34. Vaughan PA, Malcolm BW, Maistrelli GL. Results of L4-L5 disc excision alone versus disc excision and fusion. Spine (Phila Pa 1976). 1988 Jun;13(6):690-5. 35. Cao P, Chen Z, Zheng Y, Wang Y, Jiang L, Yang Y, Zhuang C, Liang Y, Zheng T,Gong Y, Zhang X, Wu W, Qiu S. Comparison of simple discectomy and instrumented posterior lumbar interbody fusion for treatment of lumbar disc herniation combined with Modic endplate changes. Chin Med J (Engl). 2014;127(15):2789-94. 36. Floman Y, Millgram MA, Smorgick Y, Rand N, Ashkenazi E. Failure of the Wallis interspinous implant to lower the incidence of recurrent lumbar disc herniations in patients undergoing primary disc excision. J Spinal Disord Tech. 2007 Jul;20(5):337-41. 37. Takeshima T, Kambara K, Miyata S, Ueda Y, Tamai S. Clinical and radiographic evaluation of disc excision for lumbar disc herniation with and without posterolateral fusion. Spine (Phila Pa 1976). 2000 Feb 15;25(4):450-6. 38. Wang JC, Dailey AT, Mummaneni PV, Ghogawala Z, Resnick DK, Watters WC 3rd,Groff MW, Choudhri TF, Eck JC, Sharan A, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neurosurg Spine. 2014 Jul;21(1):48-53. doi: 10.3171/2014.4. 39. http://www.icd10data.com/ICD10CM/Codes/M00-M99/M50-M54/M51-/M51.06. Accessed december 6, 2018. 40. http://www.icd9data.com/2015/Volume3/76-84/81/default.htm#81.07. Accessed december 6, 2018. 41. Pfirrmann CW, Metzdorf A, Zanetti M, Hodler J, Boos N. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976).2001 Sep 1;26(17):1873-8. 42. Mirza SK, Deyo RA, Heagerty PJ, Turner JA, Lee LA, Goodkin R. Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation. BMC Musculoskelet Disord. 2006 Jun 20;7:53. 43. S Alcántara-Bumbiedro, MT Flórez-García, C Echávarri-pérez Y F García-Pérez. Escala de incapacidad por dolor lumbar de Oswestry. Rehabilitación (Madr).2006;40(3):150-8. 44. Phan K, Kim JS, Somani S, Di Capua J, Kim R, Shin J, Cho SK. Impact of Age on 30-day Complications After Adult Deformity Surgery. Spine (Phila Pa 1976). 2018 Jan 15;43(2):120-126. doi: 10.1097/BRS.0000000000001832. 45.Gelalis ID, Paschos NK, Pakos EE, Politis AN, Arnaoutoglou CM, Karageorgos AC,Ploumis A, Xenakis TA. Accuracy of pedicle screw placement: a systematic review of prospective in vivo studies comparing free hand, fluoroscopy guidance and navigation techniques. Eur Spine J. 2012 Feb;21(2):247-55. doi:10.1007/s00586-011-2011-3. 46. Dakhil-Jerew F, Jadeja H, Cohen A, Shepperd JA. Inter-observer reliability of detecting Dynesys pedicle screw using plain X-rays: a study on 50 post-operative patients. Eur Spine J. 2009 Oct;18(10):1486-93. doi: 10.1007/s00586-009-1071-0. 47. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10. 48. Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni P,Watters WC 3rd, Wang J, Walters BC, Hadley MN; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neurosurg Spine.2005 Jun;2(6):673-8. 49. Strömqvist BH, Berg S, Gerdhem P, Johnsson R, Möller A, Sahlstrand T, Soliman A, Tullberg T. X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine (Phila Pa 1976). 2013 Aug 1;38(17):1436-42. doi: 10.1097/BRS.0b013e31828ba413. 50. Richter A, Halm HF, Hauck M, Quante M. Two-year follow-up after decompressive surgery with and without implantation of an interspinous device for lumbar spinal stenosis: a prospective controlled study. J Spinal Disord Tech. 2014 Aug;27(6):336-41. doi:10.1097/BSD.0b013e31825f7203. 51. Moojen WA, Arts MP, Jacobs WC, van Zwet EW, van den Akker-van Marle ME, Koes BW, Vleggeert-Lankamp CL, Peul WC; Leiden-The Hague Spine Intervention Prognostic Study Group. Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ. 2013 Nov 14;347:f6415. doi: 10.1136/bmj.f6415. 52. Wu AM, Zhou Y, Li QL, Wu XL, Jin YL, Luo P, Chi YL, Wang XY. Interspinous spacer versus traditional decompressive surgery for lumbar spinal stenosis: a systematic review and meta-analysis. PLoS One. 2014 May 8;9(5):e97142. doi:10.1371/journal.pone.0097142 53. Hallett A, Huntley JS, Gibson JN. Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion. Spine (Phila Pa 1976). 2007 Jun 1;32(13):1375-80. 54. Lee SH, Seol A, Cho TY, Kim SY, Kim DJ, Lim HM. A Systematic Review of Interspinous Dynamic Stabilization. Clin Orthop Surg. 2015 Sep;7(3):323-9. doi:10.4055/cios.2015.7.3.323. 55. Woo EJ, Ogilvie RA, Krueger VS, Lundin M, Williams DM. Iliac vein compression syndrome from anterior perforation of a pedicle screw. J Surg Case Rep. 2016 Feb 23;2016(2). doi:10.1093/jscr/rjw003. 56. Ergur I, Akcali O, Kiray A, Kosay C, Tayefi H. Neurovascular risks of sacral screws with bicortical purchase: an anatomical study. Eur Spine J. 2007 Sep;16(9):1519-23. 57. Foxx KC, Kwak RC, Latzman JM, Samadani U. A retrospective analysis of pedicle screws in contact with the great vessels. J Neurosurg Spine. 2010 Sep;13(3):403-6. doi: 10.3171/2010.3. 58. Puvanesarajah V, Werner BC, Cancienne JM, Jain A, Pehlivan H, Shimer AL,Singla A, Shen F, Hassanzadeh H. Morbid Obesity and Lumbar Fusion in Patients Older Than 65 Years: Complications, Readmissions, Costs, and Length of Stay.Spine (Phila Pa 1976). 2017 Jan 15;42(2):122-127. doi:10.1097/BRS.0000000000001692 59. Kalevski SK, Peev NA, Haritonov DG. Incidental Dural Tears in lumbar decompressive surgery: Incidence, causes, treatment, results. Asian J Neurosurg. 2010 Jan;5(1):54-9. 60. Gazzeri R, Galarza M, Neroni M, Fiore C, Faiola A, Puzzilli F, Callovini G,Alfieri A. Failure rates and complications of interspinous process decompression devices: a European multicenter study. Neurosurg Focus. 2015 Oct;39(4):E14. doi: 10.3171/2015.7.FOCUS15244. 61. Bernatz JT, Anderson PA. Thirty-day readmission rates in spine surgery: systematic review and meta-analysis. Neurosurg Focus. 2015 Oct;39(4):E7. doi: 10.3171/2015.7.FOCUS1534. 62. Jain N, Virk SS, Phillips FM, Yu E, Khan SN. A 90-day Bundled Payment for Primary Single-level Lumbar Discectomy/Decompression: What Does "Big Data" Say? Clin Spine Surg. 2018 Apr;31(3):120-126. doi: 10.1097/BSD.0000000000000550. 63. Zygourakis CC, Liu CY, Wakam G, Moriates C, Boscardin C, Ames CP, Mummaneni PV, Ratliff J, Dudley RA, Gonzales R. Geographic and Hospital Variation in Cost of Lumbar Laminectomy and Lumbar Fusion for Degenerative Conditions. Neurosurgery. 2017 Aug 1;81(2):331-340. doi: 10.1093/neuros/nyx047. 64. German JW, Adamo MA, Hoppenot RG, Blossom JH, Nagle HA. Perioperative results following lumbar discectomy: comparison of minimally invasive discectomy and standard microdiscectomy. Neurosurg Focus. 2008;25(2):E20. doi:10.3171/FOC/2008/25/8/E20. 65. Brewin CR, Bradley C. Patient preferences and randomised clinical trials. Brit Med J 1989;299:313-315. 66. Sedwick P. What is a patient preference trial? Brit Med J. 2013; 347. 67. McPherson K, Britton AR, Wennberg JE. Are randomised trials controlled? Patient preferences and unblind trials. J Roy Soc Med. 1997; 90: 652-656. 68. Millat B, Borie F, Fingerhut A. Patient’s preference and randomization: new paradigm of evidence- based clinical research. World J Surg. 2005; 29(5): 596-600.