scholarly journals Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS® in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication

2012 ◽  
Vol 21 (12) ◽  
pp. 2565-2572 ◽  
Author(s):  
Jan Van Meirhaeghe ◽  
Patrick Fransen ◽  
Daniele Morelli ◽  
Niall J. A. Craig ◽  
Gregor Godde ◽  
...  
2017 ◽  
Vol 14 (3) ◽  
pp. 67-73 ◽  
Author(s):  
Valery Lebedev ◽  
◽  
Dmitry Epifanov ◽  
Gleb Kostenko ◽  
Tousif Ghodivala ◽  
...  

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.


2009 ◽  
Vol 10 (6) ◽  
pp. 587-594 ◽  
Author(s):  
Ko Matsudaira ◽  
Takashi Yamazaki ◽  
Atsushi Seichi ◽  
Kazuto Hoshi ◽  
Nobuhiro Hara ◽  
...  

The authors developed an original procedure, modified fenestration with restorative spinoplasty (MFRS) for the treatment of lumbar spinal stenosis. The first step is to cut the spinous process in an L-shape, which is caudally reflected. This procedure allows easy access to the spinal canal, including lateral recesses, and makes it easy to perform a trumpet-style decompression of the nerve roots without violating the facet joints. After the decompression of neural tissues, the spinous process is anatomically restored (spinoplasty). The clinical outcomes at 2 years were evaluated using the Japanese Orthopaedic Association (JOA) scale and patients' satisfaction. Radiological follow-up included radiographs and CT. Between January 2000 and December 2002, 109 patients with neurogenic intermittent claudication with or without mild spondylolisthesis underwent MFRS. Of these, 101 were followed up for at least 2 years (follow-up rate 93%). The average score on the self-administered JOA scale in 89 patients without comorbidity causing gait disturbance improved from 13.3 preoperatively to 22.9 at 2 years' follow-up. Neurogenic intermittent claudication disappeared in all cases. The patients' assessment of treatment satisfaction was “satisfied” in 74 cases, “slightly satisfied” in 12, “slightly dissatisfied” in 2, and “dissatisfied” in 1 case. In 16 cases (18%), a minimum progression of slippage occurred, but no symptomatic instability or recurrent stenosis was observed. Computed tomography showed that the lateral part of the facet joints was well preserved, and the mean residual ratio was 80%. The MFRS technique produces an adequate and safe decompression of the spinal canal, even in patients with narrow and steep facet joints in whom conventional fenestration is technically demanding.


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