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Biomed Res Int. 2016;2016:3267307. Epub 2016 Oct 13.

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis.

Author information

1
Spine Institute of Louisiana, Shreveport, LA 71101, USA.
2
Ronald Reagan UCLA Medical Center, Westwood, CA 90095, USA.
3
Texas Back Institute, Plano, TX 75093, USA.
4
Spine Colorado, Durango, CO 81301, USA.
5
2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA.
6
401 N. Wabash Avenue, Suite 62F, Chicago, IL 60611, USA.

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.

PMID:
27819001
PMCID:
PMC5081441
DOI:
10.1155/2016/3267307
[Indexed for MEDLINE]
Free PMC Article

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