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

Authors Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH

Received 8 June 2017

Accepted for publication 18 July 2017

Published 6 September 2017 Volume 2017:12 Pages 1409—1417


Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Akshita Wason

Peer reviewer comments 2

Editor who approved publication: Dr Richard Walker

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

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