The X-Stop® Spacer for the symptons of lumbar spninal stenosis
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Clinical references

  1. Amundsen T, Weber H, Nordal HJ, Magnaes B, Abdelnoor M, Lilleâs F. Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study. Spine. 2000;25:1424-1435.

  2. Ciol MA, Deyo RA, Howell E, Kreif S. An assessment of surgery for spinal stenosis: time trends, geographic variations, complications, and reoperations. J Am Geriatr Soc. 1996;44:285-290.

  3. Currie SR, Wang JL. Chronic back pain and major depression in the general Canadian population. Pain. 2004;107:54-60.

  4. Data on file. Medtronic, Inc., 2008.

  5. Food and Drug Administration. New device approval: X STOP interspinous process decompression system (P040001). November 21, 2005. Available at: http://www.fda.gov/cdrh/mda/docs/p040001.html. Accessed July 20, 2008.

  6. Herkowitz HN, El-Kommos H. Spinal stenosis: clinical evaluation and differential diagnosis. In: Rothman RH, Simeone FA, eds. The Spine. Philadelphia, Pa: WB Saunders; 1993:827-830.

  7. Hsu KY, Zucherman JF, Hartjen CA, et al. Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006;5:500-507.

  8. Johnsson K-E, Rosén I, Udén A. The natural course of lumbar spinal stenosis. Clin Orthop Relat Res. 1992;279:82-86.

  9. Katz JN, Lipson SJ, Larson MG, McInnes JM, Fossel AH, Liang MH. The outcome of decompressive laminectomy for degenerative lumbar stenosis. J Bone Joint Surg Am. 1991;73:809-816.

  10. Kondrashov DG, Hannibal M, Hsu KY, Zucherman JF. Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study. J Spinal Disord Tech. 2006;19:323-327.

  11. Silvers HR, Lewis PJ, Asch HL. Decompressive lumbar laminectomy for spinal stenosis. J Neurosurg. 1993;78:695-701.

  12. Swezey RL. Outcomes for lumbar stenosis: a 5-year follow-up study. J Clin Rheumatol. 1996;2:129-133.

  13. Treatment of Degenerative Lumbar Spinal Stenosis. Volume 1: Evidence Report. Rockville, Md: Agency for Healthcare Research and Quality, US Dept. of Health and Human Services; 2001. AHRQ Publication No. 01-E048.

  14. Weinstein JN, Tosteson TD, Lurie JD, et al, for the SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. NEJM. 2008;358:794-810.

  15. X STOP® IPD® System Summary of Safety and Effectiveness, 2005.

  16. Zucherman JF, Hsu KY, Hartjen CA, 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. 2005;30:1351-1358.

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This treatment is prescribed by your doctor. It is not for everyone. Please talk with your doctor and see if it is right for you. Your doctor should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, approximately half of the patients who received the X-STOP device in the 2-year study experienced a degree of pain relief and ability to increase their activity levels that was sufficient to be considered a successful outcome at 2 years after surgery. This compares with the control group treated with non-surgical care that had a 6% successful outcome treatment success rate.15