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Pain Research and Treatment
Volume 2012 (2012), Article ID 823509, 10 pages
http://dx.doi.org/10.1155/2012/823509
Clinical Study

Interspinous Spacer Implant in Patients with Lumbar Spinal Stenosis: Preliminary Results of a Multicenter, Randomized, Controlled Trial

1Miller Scientific Consulting, Inc., 26 Portobello Road, Arden, NC 28704, USA
2The Jon Block Group, 2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA

Received 24 June 2011; Revised 26 September 2011; Accepted 24 October 2011

Academic Editor: Howard S. Smith

Copyright © 2012 Larry E. Miller and Jon E. Block. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. H. Çavuşoǧlu, R. A. Kaya, O. N. Türkmenoglu, C. Tuncer, I. Çolak, and Y. AydIn, “Midterm outcome after unilateral approach for bilateral decompression of lumbar spinal stenosis: 5-year prospective study,” European Spine Journal, vol. 16, no. 12, pp. 2133–2142, 2007. View at Publisher · View at Google Scholar
  2. S. S. Chung, C. S. Lee, S. H. Kim, M. W. Chung, and J. M. Ahn, “Effect of low back posture on the morphology of the spinal canal,” Skeletal Radiology, vol. 29, no. 4, pp. 217–223, 2000. View at Publisher · View at Google Scholar · View at Scopus
  3. K. E. Johnsson, I. Rosen, and A. Uden, “The natural course of lumbar spinal stenosis,” Clinical Orthopaedics and Related Research, no. 279, pp. 82–86, 1992. View at Google Scholar · View at Scopus
  4. D. A. Chad, “Lumbar spinal stenosis,” Neurologic Clinics, vol. 25, no. 2, pp. 407–418, 2007. View at Publisher · View at Google Scholar · View at Scopus
  5. K. E. Johnsson, “Lumbar spinal stenosis: a retrospective study of 163 cases in southern Sweden,” Acta Orthopaedica Scandinavica, vol. 66, no. 5, pp. 403–405, 1995. View at Google Scholar · View at Scopus
  6. R. A. Deyo, S. K. Mirza, B. I. Martin, W. Kreuter, D. C. Goodman, and J. G. Jarvik, “Trends, major nedical complications, and charges associated with surgery for lumbar spinal stenosis in older adults,” Journal of the American Medical Association, vol. 303, no. 13, pp. 1259–1265, 2010. View at Publisher · View at Google Scholar · View at Scopus
  7. J. D. Markman and K. G. Gaud, “Lumbar spinal stenosis in older adults: current understanding and future directions,” Clinics in Geriatric Medicine, vol. 24, no. 2, pp. 369–388, 2008. View at Publisher · View at Google Scholar · View at Scopus
  8. R. A. Deyo, “Drug therapy for back pain: which drugs help which patients?” Spine, vol. 21, no. 24, pp. 2840–2849, 1996. View at Publisher · View at Google Scholar
  9. J. M. Cuckler, P. A. Bernini, S. W. Wiesel, R. E. Booth Jr., R. H. Rothman, and G. T. Pickens, “The use of epidural steroids in the treatment of lumbar radicular pain,” Journal of Bone and Joint Surgery—Series A, vol. 67, no. 1, pp. 63–66, 1985. View at Google Scholar
  10. S. J. Atlas, R. B. Keller, Y. A. Wu, R. A. Deyo, and D. E. Singer, “Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the Maine lumbar spine study,” Spine, vol. 30, no. 8, pp. 927–935, 2005. View at Publisher · View at Google Scholar · View at Scopus
  11. E. Chen, K. B. Tong, and M. Laouri, “Surgical treatment patterns among medicare beneficiaries newly diagnosed with lumbar spinal stenosis,” Spine Journal, vol. 10, no. 7, pp. 588–594, 2010. View at Publisher · View at Google Scholar · View at Scopus
  12. J. N. Katz, S. J. Lipson, R. A. Lew et al., “Lumbar laminectomy alone or with instrumented or noninstrumented arthrodesis in degenerative lumbar spinal stenosis: patient selection, costs, and surgical outcomes,” Spine, vol. 22, no. 10, pp. 1123–1131, 1997. View at Publisher · View at Google Scholar · View at Scopus
  13. J. N. Weinstein, J. D. Lurie, T. D. Tosteson et al., “Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis,” The New England Journal of Medicine, vol. 356, no. 22, pp. 2257–2270, 2007. View at Publisher · View at Google Scholar · View at Scopus
  14. G. Li, C. G. Patil, S. P. Lad, C. Ho, W. Tian, and M. Boakye, “Effects of age and comorbidities on complication rates and adverse outcomes after lumbar laminectomy in elderly patients,” Spine, vol. 33, no. 11, pp. 1250–1255, 2008. View at Publisher · View at Google Scholar · View at Scopus
  15. R. A. Hart and M. A. Prendergast, “Spine surgery for lumbar degenerative disease in elderly and osteoporotic patients,” Instructional Course Lectures, vol. 56, pp. 257–272, 2007. View at Google Scholar · View at Scopus
  16. H. Verbiest, “A radicular syndrome from developmental narrowing of the lumbar vertebral canal,” Journal of Bone and Joint Surgery, vol. 36-B, no. 2, pp. 230–237, 1954. View at Google Scholar
  17. J. Kuchta, R. Sobottke, P. Eysel, and P. Simons, “Two-year results of interspinous spacer (X-Stop) implantation in 175 patients with neurologic intermittent claudication due to lumbar spinal stenosis,” European Spine Journal, vol. 18, no. 6, pp. 823–829, 2009. View at Publisher · View at Google Scholar · View at Scopus
  18. R. Sobottke, K. Schlüter-Brust, T. Kaulhausen et al., “Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome?” European Spine Journal, vol. 18, no. 10, pp. 1494–1503, 2009. View at Publisher · View at Google Scholar · View at Scopus
  19. R. Chou, J. Baisden, E. J. Carragee, D. K. Resnick, W. O. Shaffer, and J. D. Loeser, “Surgery for low back pain: a review of the evidence for an American pain society clinical practice guideline,” Spine, vol. 34, no. 10, pp. 1094–1109, 2009. View at Publisher · View at Google Scholar · View at Scopus
  20. American Society for Testing and Materials, “ASTM F136-02a: standard specification for wrought titanium-6 aluminum-4 vanadium ELI (extra low interstitial) alloy for surgical implant applications (UNS R56401),” 2002. View at Google Scholar
  21. J. C. Chiu, “Interspinous process decompression (IPD) system (X-STOP) for the treatment of lumbar spinal stenosis,” Surgical Technology International, vol. 15, pp. 265–275, 2006. View at Google Scholar · View at Scopus
  22. M. Siddiqui, F. W. Smith, and D. Wardlaw, “One-year results of X STOP interspinous implant for the treatment of lumbar spinal stenosis,” Spine, vol. 32, no. 12, pp. 1345–1348, 2007. View at Publisher · View at Google Scholar · View at Scopus
  23. J. C. T. Fairbank and P. B. Pynsent, “The oswestry disability index,” Spine, vol. 25, no. 22, pp. 2940–2952, 2000. View at Publisher · View at Google Scholar
  24. J. N. S. Matthews, D. G. Altman, M. J. Campbell, and P. Royston, “Analysis of serial measurements in medical research,” British Medical Journal, vol. 300, no. 6719, pp. 230–235, 1990. View at Google Scholar · View at Scopus
  25. R. W. J. G. Ostelo, R. A. Deyo, P. Stratford et al., “Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change,” Spine, vol. 33, no. 1, pp. 90–94, 2008. View at Publisher · View at Google Scholar · View at Scopus
  26. O. Hägg, P. Fritzell, and A. Nordwall, “The clinical importance of changes in outcome scores after treatment for chronic low back pain,” European Spine Journal, vol. 12, no. 1, pp. 12–20, 2003. View at Google Scholar · View at Scopus
  27. J. Zigler, R. Delamarter, J. M. Spivak et al., “Results of the prospective, randomized, multicenter food and drug administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease,” Spine, vol. 32, no. 11, pp. 1155–1162, 2007. View at Publisher · View at Google Scholar
  28. W. Bini, L. E. Miller, and J. E. Block, “Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer: preliminary results,” Open Orthopaedics Journal, vol. 5, pp. 361–367, 2011. View at Google Scholar
  29. A. Goyal, V. K. Goel, A. Mehta, D. Dick, S. R. Chinthakunta, and L. Ferrara, “Cyclic loads do not compromise functionality of the interspinous spacer or cause damage to the spinal segment: an in vitro analysis,” Journal of Long-Term Effects of Medical Implants, vol. 18, no. 4, pp. 289–302, 2008. View at Google Scholar · View at Scopus