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Minimum 2-Year Follow-Up Result of Degenerative Spinal Stenosis Treated with Interspinous U ($Coflex^{TM}$)

  • Park, Seong-Cheol (Department of Neurosurgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine) ;
  • Yoon, Sang-Hoon (Department of Neurosurgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine) ;
  • Hong, Yong-Pyo (Department of Neurosurgery, Seoul Chuk Spine Hospital) ;
  • Kim, Ki-Jeong (Department of Neurosurgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine) ;
  • Chung, Sang-Ki (Department of Neurosurgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine) ;
  • Kim, Hyun-Jib (Department of Neurosurgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine)
  • Published : 2009.10.28

Abstract

Objective : Clinical and radiological results of posterior dynamic stabilization using interspinous U (ISU, $Coflex^{TM}$, Paradigm Spine $Inc.^{(R)}$, NY, USA) were analyzed in comparison with posterior lumbar interbody fusion (PLIF) in degenerative lumbar spinal stenosis (LSS). Methods : A retrospective study was conducted for a consecutive series of 61 patients with degenerative LSS between May 2003 and December 2005. We included only the patients completed minimum 24 months follow up evaluation. Among them, 30 patients were treated with implantation of ISU after decompressive laminectomy (Group ISU) and 31 patients were treated with wide decompressive laminectomy and posterior lumbar interbody fusion (PLIF; Group PLIF). We evaluated visual analogue scale (VAS) and Oswestry Disability Index (ODI) for clinical outcomes (VAS, ODI), disc height ratio disc height (DH), disc height/vertebral body length ${\times}100$), static vertebral slip (VS) and depth of maximal radiolucent gap between ISU and spinous process) in preoperative, immediate postoperative and last follow up. Results : The mean age of group ISU ($66.2{\pm}6.7$ years) was 6.2 years older than the mean age of group PLIF ($60.4{\pm}8.1$ years; p=0.003). In both groups, clinical measures improved significantly than preoperative values (p<0.001). Operation time and blood loss was significantly shorter and lower in group ISU than group PLIF (p<0.001). In group ISU, the DH increased transiently in immediate postoperative period ($15.7{\pm}4.5%{\rightarrow}18.6{\pm}5.9%$), however decreased significantly in last follow up ($13.8{\pm}6.6%$, p=0.027). Vertebral slip (VS) of spondylolisthesis in group ISU increased during postoperative follow-up ($2.3{\pm}3.3{\rightarrow}8.7{\pm}6.2$, p=0.040). Meanwhile, the postoperatively improved DH and VS was maintained in group PLIF in last follow up. Conclusion : According to our result, implantation of ISU after decompressive laminectomy in degenerative LSS is less invasive and provides similar clinical outcome in comparison with the instrumented fusion. However, the device has only transient effect on the postoperative restoration of disc height and reduction of slip in spondylolisthesis. Therefore, in the biomechanical standpoint, it is hard to expect that use of Interspinous U in decompressive laminectomy for degenerative LSS had long term beneficial effect.

Keywords

References

  1. Adelt D, Samani J, Kim W, Eif M, Lowery GL, Chomiak RJ : Coflex interspinous stabilization : Clinical and Radiographic results from an international multicenter retrospective study. Paradigm Spine Journal 1 : 1-4, 2007
  2. Bae YS, Ha Y, Ahn PG, Lee DY, Yi S, Kim KN, et al. : Interspinous implantation for degnerative lumbar spine : clinical and radiologic outcome at 3-yr follow up. Korean J Spine 5 : 130-135, 2008
  3. Bono CM, Vaccaro AR : Interspinous process devices in the lumbar spine. J Spinal Disord Tech 20 : 255-261, 2007 https://doi.org/10.1097/BSD.0b013e3180331352
  4. Christie SD, Song JK, Fessler RG : Dynamic interspinous process technology. Spine (Phila Pa 1976) 30 : S73-S78, 2005
  5. Deyo RA, Cherkin DC, Loeser JD, Bigos SJ, Ciol MA : Morbidity and mortality in association with operations on the lumbar spine. The influence of age, diagnosis, and procedure. J Bone Joint Surg Am 74 : 536-543, 1992
  6. Friberg O : Functional radiography of the lumbar spine. Ann Med 21 : 341-346, 1989 https://doi.org/10.3109/07853898909149218
  7. Hur JW, Kim SH, Lee JW, Lee HK : Clinical analysis of postoperative outcome in elderly patients with lumbar spinal stenosis. J Korean Neurosurg Soc 41 : 157-160, 2007 https://doi.org/10.3340/jkns.2007.41.3.157
  8. Kaech DL : The interspinous-U : A new restabilization device for the lumbar spine. Spinal Restabilization Procedures. Amsterdam : Elsvier, 2002, pp355-362
  9. Kong DS, Kim ES, Eoh W : One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J Korean Med Sci 22 : 330-335, 2007 https://doi.org/10.3346/jkms.2007.22.2.330
  10. Lim HJ, Roh SW, Jeon SR, Rhim SC : Early experience with interspinous U in the management of the degenerative lumbar disease. Korean J Spine 1 : 456-462, 2004
  11. Lindsey DP, Swanson KE, Fuchs P, Hsu KY, Zucherman JF, Yerby SA : The effects of an interspinous implant on the kinematics of the instrumented and adjacent levels in the lumbar spine. Spine (Phila Pa 1976) 28 : 2192-2197, 2003 https://doi.org/10.1097/01.BRS.0000084877.88192.8E
  12. Park CK, Kim DH, Kim MK, Ryu KS : Effects of 'Interspinous-U' on posterior stabilization of the lumbar spine following decompressive surgery in lumbar spinal stenosis : Minimum 27-month follow-up. World Spine IV. Istanbul : World Spine Society, 2007
  13. Park P, Garton HJ, Gala VC, Hoff JT, McGillicuddy JE : Adjacent segment disease after lumbar or lumbosacral fusion : review of the literature. Spine 29 : 1938-1944, 2004 https://doi.org/10.1097/01.brs.0000137069.88904.03
  14. Park YS, Kim YB, Lee DG, Kim KT, Nam TK : Dynamic stabilization with an interspinous process device (the Wallis system) for degenerative disc disease and lumbar spinal stenosis. Korean J Spine 5 : 258-263, 2008
  15. Prolo DJ, Oklund SA, Butcher M : Toward uniformity in evaluating results of lumbar spine operations. A paradigm applied to posterior lumbar interbody fusions. Spine (Phila Pa 1976) 11 : 601-606, 1986 https://doi.org/10.1097/00007632-198607000-00012
  16. Richards JC, Majumdar S, Lindsey DP, Beaupre GS, Yerby SA : The treatment mechanism of an interspinous process implant for lumbar neurogenic intermittent claudication. Spine (Phila Pa 1976) 30 : 744-749, 2005 https://doi.org/10.1097/01.brs.0000157483.28505.e3
  17. Schnake KJ, Schaeren S, Jeanneret B : Dynamic stabilization in addition to decompression for lumbar spinal stenosis with degenerative spondylolisthesis. Spine (Phila Pa 1976) 31 : 442-449, 2006 https://doi.org/10.1097/01.brs.0000200092.49001.6e
  18. Siddiqui M, Smith FW, Wardlaw D : One-year results of X Stop interspinous implant for the treatment of lumbar spinal stenosis. Spine (Phila Pa 1976) 32 : 1345-1348, 2007 https://doi.org/10.1097/BRS.0b013e31805b7694
  19. Simmons ED Jr, Simmons EH : Spinal stenosis with scoliosis. Spine (Phila Pa 1976) 17 : S117-120, 1992 https://doi.org/10.1097/00007632-199206001-00009
  20. Stoll TM, Dubois G, Schwarzenbach O : The dynamic neutralization system for the spine : a multi-center study of a novel nonfusion system. Eur Spine J 11 Suppl 2 : S170-178, 2002
  21. Taylor J, Pupin P, Delajoux S, Palmer S : Device for intervertebral assisted motion : technique and initial results. Neurosurg Focus 22 : E6, 2007
  22. Verhoof OJ, Bron JL, Wapstra FH, van Royen BJ : High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis. Eur Spine J 17 : 188-192, 2008 https://doi.org/10.1007/s00586-007-0492-x
  23. 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 17 : 1049-1056, 2008 https://doi.org/10.1007/s00586-008-0657-2
  24. Wiseman CM, Lindsey DP, Fredrick AD, Yerby SA : The effect of an interspinous process implant on facet loading during extension. Spine (Phila Pa 1976) 30 : 903-907, 2005 https://doi.org/10.1097/01.brs.0000158876.51771.f8
  25. Yoon SM, Lee SG, Park CW, Yoo CJ, Kim DY, Kim WK : Late complications of the single level ‘interspinous U’ in lumbar spinal stenosis with mild segmental instability. Korean J Spine 5 : 89-94, 2008
  26. Yoon SM, Lee SG, Kim EY, Kim WK : Follow-up comparison study of single-level posterior dynamic stabilization in lumbar degenerative disease 'Interspinous U' vs. 'DIAM'. Korean J Spine 5 : 136-141, 2008
  27. Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, et al. : A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication : two-year follow-up results. Spine (Phila Pa 1976) 30 : 1351-1358, 2005 https://doi.org/10.1097/01.brs.0000166618.42749.d1

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