RESEARCH ARTICLE


Minimally Invasive Treatment of Moderate Lumbar Spinal Stenosis with the Superion® Interspinous Spacer



Walter Bini1, Larry E Miller2, 3, Jon E Block*, 3
1 Neurosurgical Division, General Hospital Dubrovnik, Dubrovnik, Croatia
2 Miller Scientific Consulting, Inc., 422 Mountain Wasp Drive, Biltmore Lake, NC 28715, USA
3 Jon E. Block, Ph.D., Inc., 2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA


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Creative Commons License
© Bini et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at Jon E. Block, Ph.D., Inc., 2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA; Tel: (415) 775- 7947; Fax: (415) 928-0765; E-mail: jonblock@jonblockphd.com


Abstract

Purpose:

We evaluated the safety and effectiveness of the minimally invasive Superion® Interspinous Spacer (VertiFlex, Inc., San Clemente, CA) in patients with moderate LSS.

Methods:

This single-arm prospective study enrolled 121 patients with moderate LSS between February 2008 and August 2009 and were followed up at 1 (n=111), 3 (n=96), 6 (n=81), and 12 (n=52) months. All patients were treated with the Superion Interspinous Spacer. Main outcomes were back function with the Oswestry Disability Index (ODI), extremity and axial pain severity with an 11-point scale, health-related quality of life with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36, and adverse events through 12 months.

Results:

ODI improved 64% (p<0.001) through 12 months and clinical success was 92%. Extremity and axial pain improved 53% and 49% (both p<0.001), respectively, through 12 months with clinical success of 76% for axial pain and 86% for extremity pain. Health-related quality of life improved 41% for PCS and 22% for MCS (both p<0.001) through 12 months. PCS clinical success was 81% and MCS clinical success was 62% at 12 months. Four (5.9%) explants were performed although 3 were unrelated to the device. Eight procedure-related adverse events, observed in 6 (5.0%) patients, included superficial incision seroma (n=5), minor wound pain (n=2), and infection (n=1).

Conclusions:

Preliminary results with the Superion Interspinous Spacer suggest that it is an effective and safe treatment option for patients with moderate LSS who are unresponsive to conservative care.

Keywords: Interspinous spacer, lumbar spinal stenosis, minimally invasive, Superion.