4.4 Article

Twelve-month results of a clinical pilot study utilizing pedicle-lengthening osteotomy for the treatment of lumbar spinal stenosis Clinical article

Journal

JOURNAL OF NEUROSURGERY-SPINE
Volume 18, Issue 4, Pages 347-355

Publisher

AMER ASSOC NEUROLOGICAL SURGEONS
DOI: 10.3171/2012.11.SPINE12402

Keywords

lumbar spine; spinal stenosis; decompression; pedicle osteotomy; minimally invasive surgery; clinical trial; functional neurosurgery

Funding

  1. Innovative Surgical Designs, Inc.

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Object. Lumbar spinal stenosis (LSS) is a common condition that leads to significant disability, particularly in the elderly. Current therapeutic modalities for LSS have certain drawbacks when applied to this patient population. The object of this study was to define the 12-month postoperative outcomes and complications of pedicle-lengthening osteotomies for symptomatic LSS. Methods. A prospective, single-treatment clinical pilot study was conducted. A cohort of 19 patients (mean age 60.9 years) with symptomatic LSS was treated by pedicle-lengthening osteotomy procedures at 1 or 2 levels. All patients had symptoms of neurogenic claudication or radiculopathy secondary to LSS and had not improved after a minimum 6-month course of nonoperative treatment. Eleven patients had a Meyerding Grade I degenerative spondylolisthesis in addition to LSS. Clinical outcomes were measured using the Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), 12-Item Short-Form Health Survey (SF-12), and a visual analog scale (VAS). Procedural variables, neurological outcomes, adverse events, and radiological imaging (plain radiographs and CT scans) were collected at the 1.5-, 3-, 6-, 9-, and 12-month time points. Results. The pedicle-lengthening osteotomies were performed through percutaneous approaches with minimal blood loss in all cases. There were no operative complications. Four adverse events occurred during the follow-up period. Clinically, significant improvement was observed in the mean values of each of the outcome scales (comparing preoperative and 12-month values): ODI scores improved from 52.3 to 28.1 (p<0.0001); the ZCQ physical function domain improved from 2.7 to 1.8 (p = 0.0021); the SF-12 physical component scale improved from 27.0 to 37.9 (p = 0.0024); and the VAS score for leg pain while standing improved from 7.2 to 2.7 (p<0.0001). Imaging studies, reviewed by an independent radiologist, showed no evidence of device subsidence, migration, breakage, or heterotopic ossification. Thin-slice CT documented healing of the osteotomy site in all patients at the 6-month time point and an increase in the mean cross-sectional area of the spinal canal of 115%. Conclusions. Treatment of patients with symptomatic LSS with a pedicle-lengthening osteotomy procedure provided substantial enlargement of the area of the spinal canal and favorable clinical results for both disease-specific and non disease-specific outcome measures at the 12-month time point. Future studies are needed to compare this technique to alternative therapies for lumbar stenosis. (http://thejns.org/doi/abs/10.3171/2013.11.SPINE12402)

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