Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis

Pierce D Nunley,1 Vikas V Patel,2 Douglas G Orndorff,3 William F Lavelle,4 Jon E Block,5 Fred H Geisler6 1Spine Institute of Louisiana, Shreveport, LA, 2The Spine Center, University of Colorado Hospital, Denver, CO, 3Spine Colorado, Mercy Regional Hospital, Durango, CO, 4Upstate Bone and J...

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Autores principales:	Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	interspinous spacer lumbar spinal stenosis Superion neurogenic claudication decompression Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/348f4f22b6e2429e81c73d57b30efa05
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spelling	oai:doaj.org-article:348f4f22b6e2429e81c73d57b30efa052021-12-02T03:10:04ZFive-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis1178-1998https://doaj.org/article/348f4f22b6e2429e81c73d57b30efa052017-09-01T00:00:00Zhttps://www.dovepress.com/five-year-durability-of-stand-alone-interspinous-process-decompression-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Pierce D Nunley,1 Vikas V Patel,2 Douglas G Orndorff,3 William F Lavelle,4 Jon E Block,5 Fred H Geisler6 1Spine Institute of Louisiana, Shreveport, LA, 2The Spine Center, University of Colorado Hospital, Denver, CO, 3Spine Colorado, Mercy Regional Hospital, Durango, CO, 4Upstate Bone and Joint Center, East Syracuse, NY, 5Independent Consultant, San Francisco, CA, 6Independent Consultant, Chicago, IL, USA Background: Lumbar spinal stenosis is the most common indication for spine surgery in older adults. Interspinous process decompression (IPD) using a stand-alone spacer that functions as an extension blocker offers a minimally invasive treatment option for intermittent neurogenic claudication associated with spinal stenosis.Methods: This study evaluated the 5-year clinical outcomes for IPD (Superion®) from a randomized controlled US Food and Drug Administration (FDA) noninferiority trial. Outcomes included Zurich Claudication Questionnaire (ZCQ) symptom severity (ss), physical function (pf), and patient satisfaction (ps) subdomains, leg and back pain visual analog scale (VAS), and Oswestry Disability Index (ODI).Results: At 5 years, 84% of patients (74 of 88) demonstrated clinical success on at least two of three ZCQ domains. Individual ZCQ domain success rates were 75% (66 of 88), 81% (71 of 88), and 90% (79 of 88) for ZCQss, ZCQpf, and ZCQps, respectively. Leg and back pain success rates were 80% (68 of 85) and 65% (55 of 85), respectively, and the success rate for ODI was 65% (57 of 88). Percentage improvements over baseline were 42%, 39%, 75%, 66%, and 58% for ZCQss, ZCQpf, leg and back pain VAS, and ODI, respectively (all P<0.001). Within-group effect sizes were classified as very large for four of five clinical outcomes (ie, >1.0; all P<0.0001). Seventy-five percent of IPD patients were free from reoperation, revision, or supplemental fixation at their index level at 5 years.Conclusion: After 5 years of follow-up, IPD with a stand-alone spacer provides sustained clinical benefit. Keywords: interspinous spacer, lumbar spinal stenosis, Superion, neurogenic claudication, decompression Nunley PDPatel VVOrndorff DGLavelle WFBlock JEGeisler FHDove Medical Pressarticleinterspinous spacerlumbar spinal stenosisSuperionneurogenic claudicationdecompressionGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 12, Pp 1409-1417 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	interspinous spacer lumbar spinal stenosis Superion neurogenic claudication decompression Geriatrics RC952-954.6
spellingShingle	interspinous spacer lumbar spinal stenosis Superion neurogenic claudication decompression Geriatrics RC952-954.6 Nunley PD Patel VV Orndorff DG Lavelle WF Block JE Geisler FH Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis
description	Pierce D Nunley,1 Vikas V Patel,2 Douglas G Orndorff,3 William F Lavelle,4 Jon E Block,5 Fred H Geisler6 1Spine Institute of Louisiana, Shreveport, LA, 2The Spine Center, University of Colorado Hospital, Denver, CO, 3Spine Colorado, Mercy Regional Hospital, Durango, CO, 4Upstate Bone and Joint Center, East Syracuse, NY, 5Independent Consultant, San Francisco, CA, 6Independent Consultant, Chicago, IL, USA Background: Lumbar spinal stenosis is the most common indication for spine surgery in older adults. Interspinous process decompression (IPD) using a stand-alone spacer that functions as an extension blocker offers a minimally invasive treatment option for intermittent neurogenic claudication associated with spinal stenosis.Methods: This study evaluated the 5-year clinical outcomes for IPD (Superion®) from a randomized controlled US Food and Drug Administration (FDA) noninferiority trial. Outcomes included Zurich Claudication Questionnaire (ZCQ) symptom severity (ss), physical function (pf), and patient satisfaction (ps) subdomains, leg and back pain visual analog scale (VAS), and Oswestry Disability Index (ODI).Results: At 5 years, 84% of patients (74 of 88) demonstrated clinical success on at least two of three ZCQ domains. Individual ZCQ domain success rates were 75% (66 of 88), 81% (71 of 88), and 90% (79 of 88) for ZCQss, ZCQpf, and ZCQps, respectively. Leg and back pain success rates were 80% (68 of 85) and 65% (55 of 85), respectively, and the success rate for ODI was 65% (57 of 88). Percentage improvements over baseline were 42%, 39%, 75%, 66%, and 58% for ZCQss, ZCQpf, leg and back pain VAS, and ODI, respectively (all P<0.001). Within-group effect sizes were classified as very large for four of five clinical outcomes (ie, >1.0; all P<0.0001). Seventy-five percent of IPD patients were free from reoperation, revision, or supplemental fixation at their index level at 5 years.Conclusion: After 5 years of follow-up, IPD with a stand-alone spacer provides sustained clinical benefit. Keywords: interspinous spacer, lumbar spinal stenosis, Superion, neurogenic claudication, decompression
format	article
author	Nunley PD Patel VV Orndorff DG Lavelle WF Block JE Geisler FH
author_facet	Nunley PD Patel VV Orndorff DG Lavelle WF Block JE Geisler FH
author_sort	Nunley PD
title	Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis
title_short	Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis
title_full	Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis
title_fullStr	Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis
title_full_unstemmed	Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis
title_sort	five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/348f4f22b6e2429e81c73d57b30efa05
work_keys_str_mv	AT nunleypd fiveyeardurabilityofstandaloneinterspinousprocessdecompressionforlumbarspinalstenosis AT patelvv fiveyeardurabilityofstandaloneinterspinousprocessdecompressionforlumbarspinalstenosis AT orndorffdg fiveyeardurabilityofstandaloneinterspinousprocessdecompressionforlumbarspinalstenosis AT lavellewf fiveyeardurabilityofstandaloneinterspinousprocessdecompressionforlumbarspinalstenosis AT blockje fiveyeardurabilityofstandaloneinterspinousprocessdecompressionforlumbarspinalstenosis AT geislerfh fiveyeardurabilityofstandaloneinterspinousprocessdecompressionforlumbarspinalstenosis
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Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis

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