X-Stop Versus Decompressive Surgery For Lumbar Neurogenic Intermittent Claudication: A Randomized Controlled Trial With 2 Years Follow-Up.
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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.
|Enheter & grupper|
Ämnesklassifikation (UKÄ) – OBLIGATORISK
|Status||Published - 2013|
|Peer review utförd||Ja|