Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis.
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 allvery 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 werevery large; laminectomy effect sizes werevery large(1.07) for symptom severity andlargefor 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.
Spine Institute of Louisiana, Shreveport, LA 71101, USA.
Pierce D
PD
Nunley
Ronald Reagan UCLA Medical Center, Westwood, CA 90095, USA.
A Nick
AN
Shamie
Texas Back Institute, Plano, TX 75093, USA.
Scott L
SL
Blumenthal
Spine Colorado, Durango, CO 81301, USA.
Douglas
D
Orndorff
2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA.
Jon E
0000-0001-9954-8938
JE
Block
401 N. Wabash Avenue, Suite 62F, Chicago, IL 60611, USA.
Fred H
FH
Geisler
D001416:Back Pain / Q000601:surgery; D019299:Decompression, Surgical / Q000295:instrumentation* / Q000379:methods*; D018795:Device Approval; D006801:Humans; D007796:Laminectomy / Q000295:instrumentation* / Q000379:methods*; D008159:Lumbar Vertebrae / Q000601:surgery*; D016032:Randomized Controlled Trials as Topic; D013130:Spinal Stenosis / Q000601:surgery*; D013523:Surgical Equipment; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration