Clinical neurology and neurosurgery
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Clin Neurol Neurosurg · Sep 2014
Randomized Controlled Trial Multicenter StudyInterspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: a multicenter study with a minimum 3-year follow-up.
Interspinous distraction devices provide an effective treatment for patients suffering from lumbar spinal stenosis and/or degenerative disk disease. The aim of this multicenter study was the prospective evaluation of patients treated for symptomatic lumbar spinal stenosis with interspinous process decompression (IPD) implants compared with a population of patients managed with conservative treatment. 542 patients affected by symptomatic lumbar spine degenerative disease were enrolled in a controlled trial. 422 patients underwent surgical treatment consisting of X-STOP device implantation, whereas 120 control cases were managed conservatively. Both patient groups underwent follow-up evaluations at 6, 12, 24, and 36 months using the Zurich Claudication Questionnaire, the Visual Analog Scale score and spinal lumbar X-rays, CT scans and MR imaging. ⋯ In 24 of 422 patients, the IPD device had to be removed, and a decompression and/or pedicle screw fixation was performed because of the worsening of neurological symptoms. Our results support the effectiveness of surgery in patients with stenosis. IPD may offer an effective and less invasive alternative to classical microsurgical posterior decompression in selected patients with spinal stenosis and lumbar degenerative disk diseases.