Interspinous distractor devices for the management of lumbar spinal stenosis: a miracle cure for a common problem?

References

• 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;44:285–90.
   PubMed Web of Science ®Google Scholar
• Arnoldi CC, Brodsky AE, Cauchoix J, Crock HV, Dommisse GF, Edgar MA, . Lumbar spinal stenosis and nerve root entrapment syndromes. Definition and classification. Clin Orthop Relat Res 1976;115:4–5.
   PubMed Web of Science ®Google Scholar
• Kalichman L, Kim DH, Li L, Guermazi A, Berkin V, Hunter DJ. Spondylolysis and spondylolisthesis: prevalence and association with low back pain in the adult community-based population. Spine (Phila Pa 1976) 2009;34:199–205.
   PubMed Web of Science ®Google Scholar
• Benoist M. The natural history of lumbar degenerative spinal stenosis. Joint Bone Spine 2002;69:450–7.
   PubMed Web of Science ®Google Scholar
• Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8–10 years results from the maine lumbar spine study. Spine (Phila Pa 1976) 2005;30:936–43.
   PubMed Web of Science ®Google Scholar
• Weinstein JN, Tosteson TD, Lurie JD, Tosteson A, Blood E, Herkowitz H, . Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial. Spine (Phila Pa 1976) 2010;35: 1329–38.
   PubMed Web of Science ®Google Scholar
• Weinstein JN, Lurie JD, Tosteson TD, Tosteson AN, Blood EA, Abdu WA, . Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976) 2008; 33:2789–800.
   PubMed Web of Science ®Google Scholar
• Katz JN, Lipson SJ, Chang LC, Levine SA, Fossel AH, Liang MH. Seven- to 10-year outcome of decompressive surgery for degenerative lumbar spinal stenosis. Spine (Phila Pa 1976) 1996;21:92–8.
   PubMed Web of Science ®Google Scholar
• Zucherman JF, Hsu KY, Hartjen CA. A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J 2004;13:22–31.
   PubMed Web of Science ®Google Scholar
• Wiseman CM, Lindsey DP, Fredrick AD, Yerby SA. The effect of an interspinous process implant on facet loading during extension. Spine (Phila Pa 1976) 2005;30:903–7.
   PubMed Web of Science ®Google Scholar
• Wilke HJ, Drumm J, Haussler K, Mack C, Steudel WI, Kettler A. Biomechanical effect of different lumbar interspinous implants on flexibility and intradiscal pressure. Eur Spine J 2008;17:1049–56.
   PubMed Web of Science ®Google Scholar
• Kettler A, Drumm J, Heuer F, Haeussler K, Mack C, Claes L, . Can a modified interspinous spacer prevent instability in axial rotation and lateral bending? A biomechanical in vitro study resulting in a new idea. Clin Biomech (Bristol, Avon) 2008;23:242–7.
   PubMed Web of Science ®Google Scholar
• 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) 2003;28:2192–7.
   PubMed Web of Science ®Google Scholar
• 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) 2005;30:744–9.
   PubMed Web of Science ®Google Scholar
• Swanson KE, Lindsey DP, Hsu KY, Zucherman JF, Yerby SA. The effects of an interspinous implant on intervertebral disc pressures. Spine (Phila Pa 1976) 2003;28:26–32.
   PubMed Web of Science ®Google Scholar
• Schulte LM, O’Brien JR, Matteini LE, Yu WD. Change in sagittal balance with placement of an interspinous spacer. Spine (Phila Pa 1976) 2011;36:E1302–5.
   PubMed Web of Science ®Google Scholar
• Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, . A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J 2004; 13:22–31.
   PubMed Web of Science ®Google Scholar
• 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) 2005;30: 1351–8.
   PubMed Web of Science ®Google Scholar
• 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; 19:323–7.
   PubMedGoogle Scholar
• Food and Drug Administration. Clinical summary P040001. Food and Drug Administration PMA review memorandum. 7-13-2004. Available from: www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4064b1_02_clinical%20memo.htm
   Google Scholar
• 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;73:809–16.
   PubMedGoogle Scholar
• Anderson PA, Tribus CB, Kitchel SH. Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis. J Neurosurg Spine 2006;4:463–71.
   PubMed Web of Science ®Google Scholar
• Tuschel A, Chavanne A, Eder C, Meissl M, Becker P, Ogon M. Implant survival analysis and failure modes of the X STOP interspinous distraction device. Spine (Phila Pa 1976) Epub ahead of print 2011 Feb 9.
   Web of Science ®Google Scholar
• 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 2008;17:188–92.
   PubMed Web of Science ®Google Scholar
• Brussee P, Hauth J, Donk RD, Verbeek AL, Bartels RH. Self-rated evaluation of outcome of the implantation of interspinous process distraction (X-Stop) for neurogenic claudication. Eur Spine J 2008;17:200–3.
   PubMed Web of Science ®Google Scholar
• 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) 2007;32:1345–8.
   PubMed Web of Science ®Google Scholar
• Bellini CM, Galbusera F, Raimondi MT, Mineo GV, Brayda-Bruno M. Biomechanics of the lumbar spine after dynamic stabilization. J Spinal Disord Tech 2007;20:423–9.
   PubMedGoogle Scholar
• Kim KA, McDonald M, Pik JH, Khoueir P, Wang MY. Dynamic intraspinous spacer technology for posterior stabilization: case-control study on the safety, sagittal angulation, and pain outcome at 1-year follow-up evaluation. Neurosurg Focus 2007;22:E7.
   PubMedGoogle Scholar
• Tamburrelli FC, Proietti L, Logroscino CA. Critical analysis of lumbar interspinous devices failures: a retrospective study. Eur Spine J 2011;20(Suppl 1):S27–S35.
   PubMedGoogle Scholar
• Barbagallo GM, Olindo G, Corbino L, Albanese V. Analysis of complications in patients treated with the X-Stop Interspinous Process Decompression System: proposal for a novel anatomic scoring system for patient selection and review of the literature. Neurosurgery 2009;65:111–9.
   PubMed Web of Science ®Google Scholar
• NICE Interventional Procedure Guidance. Interventional procedure overview of interspinous distraction procedures for lumbar spinal stenosis causing neurogenic claudication. IP 191/2 . 2009. Available from: www.nice.org.uk/ip
   Google Scholar