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. 2011:5:361-7.
doi: 10.2174/1874325001105010361. Epub 2011 Oct 14.

Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer

Walter Bini  1 , Larry E Miller, Jon E Block
Affiliations

Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer

Walter Bini et al. Open Orthop J. 2011.

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; Superion.; lumbar spinal stenosis; minimally invasive.

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Figures

Fig. (1)
Fig. (1)
Superion Interspinous Spacer in situ. (a) A/P view, (b) lateral view.
Fig. (2)
Fig. (2)
(a) A/P and (b) lateral radiographic image showing a properly placed Superion Interspinous Spacer.
Fig. (3)
Fig. (3)
Improvement in back function through 12 months posttreatment.
Fig. (4)
Fig. (4)
Back function clinical success rates through 12 months post-treatment.
Fig. (5)
Fig. (5)
Improvement in pain severity through 12 months posttreatment.
Fig. (6)
Fig. (6)
Pain severity clinical success rates through 12 months post-treatment.
Fig. (7)
Fig. (7)
SF-36 assessment of quality of life through 12 months post-treatment.
Fig. (8)
Fig. (8)
Physical Component Summary and Mental Component Summary score improvement through 12 months post-treatment.
Fig. (9)
Fig. (9)
Physical Component Summary and Mental Component Summary success rates through 12 months post-treatment.
Fig. (10)
Fig. (10)
A/P (a) and lateral (b) radiographs comparing the profile of the X-STOP versus the Superion interspinous spacers.
See this image and copyright information in PMC

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