title: Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: a multicenter study with a minimum 3-year follow-up.
abstract: 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. One-year follow-up evaluation revealed positive good results in the 83.5% of patients treated with IPD with respect to 50% of the nonoperative group cases. During the first three years, in 38 out of the 120 control cases, a posterior decompression and/or spinal fixation was performed because of unsatisfactory results of the conservative therapy. 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.
authors: Department of Neurosurgery, "Sandro Pertini" Hospital, Rome, Italy.
authors: Fabrizio
authors: F
authors: Puzzilli
authors: Department of Neurosurgery, San Giovanni Addolorata Hospital, Rome, Italy. Electronic address: robertogazzeri@gmail.com.
authors: Roberto
authors: R
authors: Gazzeri
authors: Regional Service of Neurosurgery, "Virgen de la Arrixaca" University Hospital, Murcia, Spain.
authors: Marcelo
authors: M
authors: Galarza
authors: Department of Neurosurgery, San Giovanni Addolorata Hospital, Rome, Italy.
authors: Massimiliano
authors: M
authors: Neroni
authors: Department of Neurosurgery, "Sandro Pertini" Hospital, Rome, Italy.
authors: Konstantinos
authors: K
authors: Panagiotopoulos
authors: Department of Neurosurgery, "Santo Spirito" Hospital, Rome, Italy.
authors: Andrea
authors: A
authors: Bolognini
authors: Department of Neurosurgery, "Santo Spirito" Hospital, Rome, Italy.
authors: Giorgio
authors: G
authors: Callovini
authors: Department of Neurosurgery, "Sandro Pertini" Hospital, Rome, Italy.
authors: Umberto
authors: U
authors: Agrillo
authors: Department of Neurosurgery and Spinal Surgery, Ruppiner Kliniken, Neuruppin, Germany.
authors: Alex
authors: A
authors: Alfieri
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019299:Decompression, Surgical / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants; D013130:Spinal Stenosis / Q000601:surgery*; D016896:Treatment Outcome
keywords: Interspinous device; Interspinous process decompression; Lumbar spinal stenosis; Spinal complications; X-STOP