Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis

Biomed Res Int. 2016;2016:3267307. doi: 10.1155/2016/3267307. Epub 2016 Oct 13.

Abstract

Interspinous process decompression is a minimally invasive implantation procedure employing a stand-alone interspinous spacer that functions as an extension blocker to prevent compression of neural elements without direct surgical removal of tissue adjacent to the nerves. The Superion® spacer is the only FDA approved stand-alone device available in the US. It is also the only spacer approved by the CMS to be implanted in an ambulatory surgery center. We computed the within-group effect sizes from the Superion IDE trial and compared them to results extrapolated from two randomized trials of decompressive laminectomy. For the ODI, effect sizes were all very large (>1.0) for Superion and laminectomy at 2, 3, and 4 years. For ZCQ, the 2-year Superion symptom severity (1.26) and physical function (1.29) domains were very large; laminectomy effect sizes were very large (1.07) for symptom severity and large for physical function (0.80). Current projections indicate a marked increase in the number of patients with spinal stenosis. Consequently, there remains a keen interest in minimally invasive treatment options that delay or obviate the need for invasive surgical procedures, such as decompressive laminectomy or fusion. Stand-alone interspinous spacers may fill a currently unmet treatment gap in the continuum of care and help to reduce the burden of this chronic degenerative condition on the health care system.

MeSH terms

  • Back Pain / surgery
  • Decompression, Surgical / instrumentation*
  • Decompression, Surgical / methods*
  • Device Approval
  • Humans
  • Laminectomy / instrumentation*
  • Laminectomy / methods*
  • Lumbar Vertebrae / surgery*
  • Randomized Controlled Trials as Topic
  • Spinal Stenosis / surgery*
  • Surgical Equipment
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration