301 - One-year Postoperative Study Results of a Flexible Microblade Shaver S...

#301 One-year Postoperative Study Results of a Flexible Microblade Shaver System for Lumbar Decompression

MIS Techniques and Outcomes

Poster Presented by: L. Dickinson

Author(s):

L. Dickinson (1)
C. Summa (2)
R. Mimran (1)
C. Lauryssen (3)

(1) Pacific Brain & Spine Medical Group, Inc, Castro Valley, CA, United States
(2) Spine Clinic of Monterey Bay, Soquel, CA, United States
(3) Lauryssen Neurosurgical Spine Institute, Los Angeles, CA, United States

Abstract

Introduction: Degenerative lumbar spinal stenosis (LSS) is the most commonly diagnosed spinal disorder in the elderly population. Laminectomy or laminotomy with a partial resection of the posterior elements is the most common procedure for the surgical treatment of lumbar spinal stenosis. Although frequently effective for decompressing the central canal, this technique is generally less effective for decompression of the lateral recess and neural foramen. Partial or total facetectomy is required to decompress these areas, but poses the risk of immediate or delayed spinal instability. The study objective was to assess the safety and effectiveness of the iO-Flex® System in reducing pain and symptom severity in patients with one or two-level lumbar spinal stenosis.

Methods: The authors reviewed the clinical findings of the 45 patients with 12-month data from the current prospective, non-randomized, multi-center study who underwent Decompressive Lumbar Surgery using the iO-Flex® System at 1- or 2-levels from L2-S1. Peri-operative and out to 12-month complications were collected. Clinical outcome evaluations compared pre- and post-operative visual analog sale (VAS) back and leg pain, Oswestry Disability Index (ODI), and the Zurich Claudication Questionnaire (ZCQ).

Results: Clinical outcome evaluations demonstrated significant improvements at the 12-month post-operative visit compared to pre-operative scores. Mean VAS back pain decreased from 49.4± 32.6 pre-operatively to 16.1± 20.2 post-operatively; Mean VAS leg pain decreased from 66.7± 24.6 to 13.4± 21.1; and Mean ODI scores improved from 43.2± 16.5 to 18.2± 15.3. The ZCQ symptom severity score reduced from 3.2± 0.6 to 1.9± 0.7.

Device or surgery related adverse events on the 45 patients with 12-month postoperative data were collected. There were 3 perioperative complication reported, 1 patient had burning in feet with a UTI and another reported radicular leg pain. The predominant late complication reported was leg pain and occurred in 8/45 or 6% of patients, and all resolved prior to the 12 month visit. One patient had a benign lumbar facet cyst but was asymptomatic. No patients were reported to have instability requiring fusion.

Conclusions: Clinically significant improvements were noted in VAS- back and leg pain, ODI and ZCQ. The limited number of complications and the favorable clinical outcomes noted demonstrates that the early results of the iO-Flex® System is effective in reducing pain and symptom severity in patients with one or two-level lumbar spinal stenosis.