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Evaluation Studies
Journal Article
Multicenter Study
Degenerative lumbar spinal stenosis with neurogenic intermittent claudication and treatment with the Aperius PercLID System: a preliminary report.
Neurosurgical Focus 2010 June
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.
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.
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