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

ABSTRACT:

Background

Interspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis (LSS) unresponsive to conservative care. The purpose of this prospective, multicenter, randomized, controlled trial was to compare 2-year clinical outcomes in patients with moderate LSS treated with the Superion(®) (Experimental) or the X-Stop(®), a FDA-approved interspinous spacer (Control).

Methods

A total of 250 patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental (n = 123) or Control (n = 127) interspinous spacer and followed through 2 years post-treatment. Complication data were available for all patients and patient-reported outcomes were available for 192 patients (101 Experimental, 91

SUBMITTER: Patel VV 

PROVIDER: S-EPMC4109165 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature