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X-Stop Versus Decompressive Surgery For Lumbar Neurogenic Intermittent Claudication: A Randomized Controlled Trial With 2 Years Follow-Up.

Strömqvist, Björn LU ; Svante, Berg; Gerdhem, Paul LU ; Johnsson, Ragnar LU ; Möller, Anders LU ; Tage, Sahlstrand; Soliman, Ahmed LU and Tycho, Tullberg (2013) In Spine 38(17).
Abstract
ABSTRACT: Study Design. Prospective randomized controlled study.Objective. To compare the outcome of indirect decompression by means of the X-Stop implant to conventional decompression in patients with neurogenic intermittent claudication due to lumbar spinal stenosis.Summary of Background Data. Decompression is the golden standard for lumbar spinal stenosis nowadays but afflicted with complications and a certain number of dissatisfied patients. Interspinous implants have been on the market for more than 10 years but no prospective study comparing its outcome to decompression has been performed.Methods. After power calculation 100 patients were included, 50 in X-Stop group and 50 in decompression group. Patients with symptomatic one- or... (More)
ABSTRACT: Study Design. Prospective randomized controlled study.Objective. To compare the outcome of indirect decompression by means of the X-Stop implant to conventional decompression in patients with neurogenic intermittent claudication due to lumbar spinal stenosis.Summary of Background Data. Decompression is the golden standard for lumbar spinal stenosis nowadays but afflicted with complications and a certain number of dissatisfied patients. Interspinous implants have been on the market for more than 10 years but no prospective study comparing its outcome to decompression has been performed.Methods. After power calculation 100 patients were included, 50 in X-Stop group and 50 in decompression group. Patients with symptomatic one- or two-level lumbar spinal stenosis and neurogenic claudication relieved on flexion were included. X-Stop operations were performed under local anaesthesia.Mean Patient Age. 69 (49-89) years, male/female distribution 56/44. Minimal dural sac area was in all cases except two ≤ 80 mm.Non-Inferiority Hypothesis. Six, 12, and 24 months follow-up. Intention-to-treat (ITT) as well as As-Treated (AT) analyses.Primary Outcome Measure. Zürich Claudication Questionnaire. Secondary outcome measures: VAS pain, SF-36, complications and re-operations.Results. Patients in both groups improved significantly regarding primary and secondary outcome measures. The results were similar at 6, 12 and 24 months and at no time point any statistical difference between the two types of surgery could be identified. Three patients (6%) in the decompression group had further surgery, compared to 13 patients (26%) in the X-Stop group (p = 0.04). Results were identical in ITT and AT analysis.Conclusion. For spinal stenosis with neurogenic claudication, decompressive surgery as well as X-Stop are rewarding procedures. Similar results were achieved in both groups, however, with a higher number of re-operations in the X-Stop group. Patients having X-Stop removal and decompression experienced results similar to those randomized to primary decompression. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Spine
volume
38
issue
17
publisher
Lippincott Williams & Wilkins
external identifiers
  • wos:000330362800011
  • pmid:23403549
  • scopus:84882455388
ISSN
0362-2436
DOI
10.1097/BRS.0b013e31828ba413
language
English
LU publication?
yes
id
5dcb8a3a-2b4f-47b4-9c63-ab07a6c2c302 (old id 3559866)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/23403549?dopt=Abstract
date added to LUP
2013-03-04 10:17:48
date last changed
2017-10-01 05:04:26
@article{5dcb8a3a-2b4f-47b4-9c63-ab07a6c2c302,
  abstract     = {ABSTRACT: Study Design. Prospective randomized controlled study.Objective. To compare the outcome of indirect decompression by means of the X-Stop implant to conventional decompression in patients with neurogenic intermittent claudication due to lumbar spinal stenosis.Summary of Background Data. Decompression is the golden standard for lumbar spinal stenosis nowadays but afflicted with complications and a certain number of dissatisfied patients. Interspinous implants have been on the market for more than 10 years but no prospective study comparing its outcome to decompression has been performed.Methods. After power calculation 100 patients were included, 50 in X-Stop group and 50 in decompression group. Patients with symptomatic one- or two-level lumbar spinal stenosis and neurogenic claudication relieved on flexion were included. X-Stop operations were performed under local anaesthesia.Mean Patient Age. 69 (49-89) years, male/female distribution 56/44. Minimal dural sac area was in all cases except two ≤ 80 mm.Non-Inferiority Hypothesis. Six, 12, and 24 months follow-up. Intention-to-treat (ITT) as well as As-Treated (AT) analyses.Primary Outcome Measure. Zürich Claudication Questionnaire. Secondary outcome measures: VAS pain, SF-36, complications and re-operations.Results. Patients in both groups improved significantly regarding primary and secondary outcome measures. The results were similar at 6, 12 and 24 months and at no time point any statistical difference between the two types of surgery could be identified. Three patients (6%) in the decompression group had further surgery, compared to 13 patients (26%) in the X-Stop group (p = 0.04). Results were identical in ITT and AT analysis.Conclusion. For spinal stenosis with neurogenic claudication, decompressive surgery as well as X-Stop are rewarding procedures. Similar results were achieved in both groups, however, with a higher number of re-operations in the X-Stop group. Patients having X-Stop removal and decompression experienced results similar to those randomized to primary decompression.},
  author       = {Strömqvist, Björn and Svante, Berg and Gerdhem, Paul and Johnsson, Ragnar and Möller, Anders and Tage, Sahlstrand and Soliman, Ahmed and Tycho, Tullberg},
  issn         = {0362-2436},
  language     = {eng},
  number       = {17},
  publisher    = {Lippincott Williams & Wilkins},
  series       = {Spine},
  title        = {X-Stop Versus Decompressive Surgery For Lumbar Neurogenic Intermittent Claudication: A Randomized Controlled Trial With 2 Years Follow-Up.},
  url          = {http://dx.doi.org/10.1097/BRS.0b013e31828ba413},
  volume       = {38},
  year         = {2013},
}