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Interspinous Spacer Implant in Patients with Lumbar Spinal Stenosis : Preliminary Results of a Multicenter, Randomized, Controlled Trial
Joint Authors
Source
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-02-07
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
A prospective, randomized, controlled trial was conducted to compare clinical outcomes in patients treated with an investigational interspinous spacer (Superion) versus those treated with an FDA-approved spacer (X-STOP).
One hundred sixty-six patients with moderate lumbar spinal stenosis (LSS) unresponsive to conservative care were treated randomly with the Superion (n=80) or X-STOP (n=86) interspinous spacer.
Study subjects were followed through 6 months posttreatment.
Zurich Claudication Questionnaire (ZCQ) symptom severity scores improved 30% with Superion and 25% with X-STOP (both P<0.001).
Similar changes were noted in ZCQ physical function with improvements of 32% with Superion and 27% with X-STOP (both P<0.001).
Mean ZCQ patient satisfaction score ranged from 1.7 to 2.0 in both groups at all follow-up visits.
The proportion of subjects that achieved at least two of three ZCQ clinical success criteria at 6 months was 75% with Superion and 67% with X-STOP.
Axial pain decreased from 55±27 mm at pretreatment to 22±26 mm at 6 months in the Superion group (P<0.001) and from 54±29 mm to 32±31 mm with X-STOP (P<0.001).
Extremity pain decreased from 61±26 mm at pretreatment to 18±27 mm at 6 months in the Superion group (P<0.001) and from 64±26 mm to 22±30 mm with X-STOP (P<0.001).
Back function improved from 38±13% to 21±19% with Superion (P<0.001) and from 40±13% to 25±16% with X-STOP (P<0.001).
Preliminary results suggest that the Superion interspinous spacer and the X-STOP each effectively alleviate pain and improve back function in patients with moderate LSS who are unresponsive to conservative care.
American Psychological Association (APA)
Miller, Larry E.& Block, Jon E.. 2012. Interspinous Spacer Implant in Patients with Lumbar Spinal Stenosis : Preliminary Results of a Multicenter, Randomized, Controlled Trial. Pain Research and Treatment،Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-500958
Modern Language Association (MLA)
Miller, Larry E.& Block, Jon E.. Interspinous Spacer Implant in Patients with Lumbar Spinal Stenosis : Preliminary Results of a Multicenter, Randomized, Controlled Trial. Pain Research and Treatment No. 2012 (2012), pp.1-10.
https://search.emarefa.net/detail/BIM-500958
American Medical Association (AMA)
Miller, Larry E.& Block, Jon E.. Interspinous Spacer Implant in Patients with Lumbar Spinal Stenosis : Preliminary Results of a Multicenter, Randomized, Controlled Trial. Pain Research and Treatment. 2012. Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-500958
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-500958