scholarly journals A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of a Standalone Percutaneous Interspinous Spacer versus Decompressive Surgery in Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication

2016 ◽  
Vol 6 (1_suppl) ◽  
pp. s-0036-1582854-s-0036-1582854
Author(s):  
Bernhard Meyer ◽  
Jean Charles Le Huec
2010 ◽  
Vol 28 (6) ◽  
pp. E3 ◽  
Author(s):  
Marcelo Galarza ◽  
Anthony P. Fabrizi ◽  
Raffaella Maina ◽  
Roberto Gazzeri ◽  
Juan F. Martínez-Lage

Object The aim of this study was to evaluate whether clinical improvement is noticeable after a minimally invasive procedure such as that used with the Aperius PercLID System in patients with degenerative lumbar spinal stenosis (DLSS) and neurogenic intermittent claudication (NIC). Methods The patients were treated with the aforementioned system at 3 different centers. The initial requirement to be included in the study was a minimum follow-up of 12 months. The authors studied 40 cases of DLSS in patients with NIC (age 72.7 ± 8.08 years). Symptom severity, physical function, quality of life, and self-rated pain were assessed preoperatively and at the 12-month follow-up using the Zurich Claudication Questionnaire (ZCQ) and a visual analog scale. The procedure was conducted under spinal (35 patients) or local (5 patients) anesthesia, using biplanar fluoroscopy for visualization. Results Single-level treatment was performed in 28 patients and 2-level treatment was performed in 12 patients. Based on time recordings in 24 cases, the mean procedural time was 19.9 ± 5.0 minutes. The mean pain visual analog scale score improved significantly from 8.1 ± 2.19 at baseline to 3.44 ± 2.89 at the 1-year follow-up. The ZCQ score for patient satisfaction showed 90% of the patients being satisfied with the procedure. The mean rates of improvement in ZCQ score for symptom severity and physical function at 1 year were 38.7 ± 33.3% and 33.8 ± 29.7%, respectively, and both proved to be statistically significant. Most improvement was seen in mobility, pain/discomfort, and ability for self-care. Conclusions In this preliminary study, the Aperius system provided clinically significant improvement after 1 year of follow-up in patients older than 65 years with DLSS and NIC.


Sign in / Sign up

Export Citation Format

Share Document