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

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.

Interspinous Spacer Implant in Patients with Lumbar Spinal Stenosis: Preliminary Results of a Multicenter, Randomized, Controlled Trial

“…The clinical outcomes with the Superion device in this clinical trial are comparable to those reported in the study of Bini and colleagues who reported 1-year outcomes of 52 patients treated with the Superion device for moderate LSS [28]. In that study, axial pain severity improved from 6.9 ± 1.1 at pretreatment to 3.4 ± 1.5 at 1 year, which represented a 49% improvement ( P < 0.001).…”

Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis

“…Data from the current study as well as from previous studies suggest that mid-term treatment effectiveness with interspinous spacers is comparable to that of open decompression surgery for moderate LSS [ 16 - 18 ]. The primary advantage of interspinous spacers is the minimally invasive approach, which is in stark contrast to the extensive resection of muscle, ligament, and bone that is typically required for traditional open decompression surgery.…”

“…The mid-term effectiveness of the Experimental device is comparable to data reported in two previous studies. Bini and colleagues [ 15 ] reported 1-year outcomes of 52 patients treated with the Experimental device for moderate LSS. In that study, axial pain severity improved 49% (p < 0.001), extremity pain severity improved 53% (p < 0.001), and back function improved 64% (p < 0.001).…”

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

“…However, after the Vertiflex procedure, there were several patients with claudication who ended up undergoing decompressive laminectomy. In a study on Vertiflex, there were no postoperative wound infections or hematoma noted [ 2 ], although another study identified a case of infection that occurred in an out of procedure-related adverse event from the Vertiflex implant [ 13 ]. Reviewing a randomized controlled trial, the incidence of non-healed spinous process fracture was 11.1% with Vertiflex, while healed spinous process fracture incidence was 5.3% [ 14 ].…”