Prospective randomized controlled multicenter study.
To compare the effect of X-Stop with minimally invasive decompression (MID) in patients with neurogenic intermittent claudication due to lumbar spinal stenosis.
Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Laminectomy has been the “gold standard,” but MID is now widely used. Another minimally invasive surgery option is X-Stop showing good result compared with nonoperative treatment, but showing higher reoperation rate than laminectomy.
We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either MID or X-Stop. Primary outcome was Zurich Claudication Questionnaire in this intention-to-treat analysis. Secondary outcome was Oswestry Disability Index, EuroQol 5-dimensional questionnaire, numerical rating scale 11 for lower back pain and leg pain, and risk for secondary surgery and complications.
No significant differences were found in Zurich Claudication Questionnaire between the groups at any follow-ups. Both groups had a statistical and clinical significant improvement at 6 weeks and throughout the 2-year observation period. The number of patients having secondary surgery due to persistent or recurrent symptoms was significantly higher in the X-Stop group, odds ratio (95% confidence interval) = 6.5 (1.3–31.9). Complication rate was similar and low, but more severe for MID.
Both MID and X-Stop led to significant symptom improvements. There were no significant clinical differences in effect between the methods at any of the follow-up time points. X-Stop had significant higher risk of secondary surgery. Complication was more severe for MID.
Level of Evidence: 2
This study compares the effect of X-Stop with minimally invasive decompression in patients with lumbar spinal stenosis. There was no difference in effect between the groups at follow-ups in the intention-to-treat analyses, but X-Stop had significant higher risk of secondary surgery. Complications were more severe for minimally invasive decompression.
*Department of Orthopedic Surgery, Innlandet Hospital Trust, Lillehammer, Norway
†Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
‡National Advisory Unit on Spinal Surgery and
§Department of Orthopedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
¶Communication and Research Unit for Musculoskeletal Disorders (FORMI), Oslo University Hospital and University of Oslo, Norway; and
‖Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Norway.
Address correspondence and reprint requests to Greger Lønne, MD, Department of Orthopaedic Surgery, Innlandet Hospital Trust, Anders Sandvigsgt 17, 2609 Lillehammer, Norway; E-mail: firstname.lastname@example.org
Acknowledgment date: May 14, 2014. First revision date: August 24, 2014. Second revision date: October 7, 2014. Acceptance date: October 26, 2014.
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
No funds were received in support of this work.
No relevant financial activities outside the submitted work.