Abstract

Lumbar spinal stenosis has been shown to negatively impact health-related quality of life. Interspinous process decompression (IPD) is a minimally invasive procedure that utilizes a stand-alone spacer to serve as a joint extension blocker to relieve neural compression in patients with spinal stenosis. Using the 5-year results from an FDA randomized controlled trial of IPD, the quality of life in 189 patients treated with the Superion® spacer was evaluated with the SF-12. Physical and mental component summary (PCS, MCS) scores were computed preoperatively and at annual intervals. For the PCS, mean scores improved from 29.4 ± 8.1 preoperatively to 41.2 ± 12.4 at 2 years (40%) and to 43.8 ± 11.6 at 5 years (49%) (p<0.001 for both comparisons). At 2 years, 81% (103 of 128) of subjects demonstrated maintenance or improvement in PCS scores. The mean MCS score improved from 50.0 ± 12.7 preoperatively to 54.4 ± 10.6 and 54.7 ± 8.6 at 2 and 5 years, respectively (p>0.10 for both comparisons). These results demonstrate that the significant impairment in physical well-being found in patients with lumbar spinal stenosis can be ameliorated, in large part, by IPD treatment.

Highlights

  • The classic clinical feature of lumbar spinal stenosis is neurogenic claudication which causes intermittent lower extremity pain and diminished functional abilities [1]

  • This multicenter trial evaluated the use of stand-alone Interspinous process decompression (IPD) in the treatment of subjects aged 45 or older with moderate symptoms of intermittent neurogenic claudication, secondary to a diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5

  • The mean physical component summary (PCS) score improved from 29.4 ± 8.1 preoperatively to 41.2 ± 12.4 at the 2-year primary trial endpoint and to 43.8 ± 11.6 at 5 years, representing average percentage improvements of 40% and 49%, respectively (p

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Summary

Introduction

The classic clinical feature of lumbar spinal stenosis is neurogenic claudication which causes intermittent lower extremity pain and diminished functional abilities [1]. Interspinous process decompression (IPD) devices (aka “spacers”) were developed to address a distinct therapeutic gap in the continuum of care of lumbar spinal stenosis treatment [3]. Interspinous spacers effectively bridge the often lengthy interval between failed conservative care and the point where surgical decompression becomes necessary to manage intractable symptoms. These devices are inserted posteriorly via a minimally invasive procedure without disruption of osseous or ligamentous tissues. Spacers provide immediate symptom amelioration by serving as a spinal extension blocker to prevent the repetitive compression of neural elements during back extension that is the primary source of claudicant symptoms

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