skip to content
Dovepress - Open Access to Scientific and Medical Research
View our mobile site

8852

Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer

Original Research

(1209) Views  (430) Full article downloads

Authors: Shabat S, Miller LE, Block JE, Gepstein R

Published Date September 2011 Volume 2011:6 Pages 227 - 233
DOI: http://dx.doi.org/10.2147/CIA.S23656

Shay Shabat1, Larry E Miller2,3, Jon E Block3, Reuven Gepstein1
1Spinal Care Unit, Sapir Medical Center, Kfar Saba, Israel; 2Miller Scientific Consulting, Inc, Biltmore Lake, NC, USA; 3Jon E Block, PhD, Inc, San Francisco, CA, USA

Purpose: To assess the safety and effectiveness of a novel, minimally invasive interspinous spacer in patients with moderate lumbar spinal stenosis (LSS).
Methods: A total of 53 patients (mean age, 70 ± 11 years; 45% female) with intermittent neurogenic claudication secondary to moderate LSS, confirmed on imaging studies, were treated with the Superion® Interspinous Spacer (VertiFlex, Inc, San Clemente, CA) and returned for follow-up visits at 6 weeks, 1 year, and 2 years. Study endpoints included axial and extremity pain severity with an 11-point numeric scale, Zurich Claudication Questionnaire (ZCQ), back function with the Oswestry Disability Index (ODI), health-related quality of life with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-12, and adverse events.
Results: Axial and extremity pain each decreased 54% (both P < 0.001) over the 2-year follow-up period. ZCQ symptom severity scores improved 43% (P < 0.001) and ZCQ physical function improved 44% (P < 0.001) from pre-treatment to 2 years post-treatment. A statistically significant 50% improvement (P < 0.001) also was noted in back function. PCS and MCS each improved 40% (both P < 0.001) from pre-treatment to 2 years. Clinical success rates at 2 years were 83%–89% for ZCQ subscores, 75% for ODI, 78% for PCS, and 80% for MCS. No device infection, implant breakage, migration, or pull-out was observed, although two (3.8%) patients underwent explant with subsequent laminectomy.
Conclusion: Moderate LSS can be effectively treated with a minimally invasive interspinous spacer. This device is appropriate for select patients who have failed nonoperative treatment measures for LSS and meet strict anatomical criteria.

Keywords: Superion, axial pain, extremity pain




 

Other articles by Dr Jon Block



Readers of this article also read:

Availability of a remote online hemodynamic monitoring system during treatment in a private dental office for medically high-risk patients
Impact of PPIs on patient focused symptomatology in GERD
Role of aliskiren in cardio-renal protection and use in hypertensives with multiple risk factors
Effects of a cellulose mask synthesized by a bacterium on facial skin characteristics and user satisfaction
Successful aging and the epidemiology of HIV
Medical treatment and long-term outcome of chronic atrial fibrillation in the aged with chest distress: a retrospective analysis versus sinus rhythm
Radio electric asymmetric brain stimulation in the treatment of behavioral and psychiatric symptoms in Alzheimer disease
Weight gain since menopause and its associations with weight loss maintenance in obese postmenopausal women
Antibody-induced secondary treatment failure in a patient treated with botulinum toxin type A for glabellar frown lines
The variations of body mass index and body fat in adult Thai people across the age spectrum measured by bioelectrical impedance analysis