Back to Journals » Journal of Pain Research » Volume 8

Superion® InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial

Authors Patel V, Nunley P, Whang P, Haley T, Bradley WD, Davis R, Block J, Geisler F

Received 18 July 2015

Accepted for publication 9 September 2015

Published 3 October 2015 Volume 2015:8 Pages 657—662


Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Kerui Gong

Peer reviewer comments 2

Editor who approved publication: Dr Michael Schatman

Vikas V Patel,1 Pierce D Nunley,2 Peter G Whang,3 Thomas R Haley,4 W Daniel Bradley,5 Raphael P Davis,6 Jon E Block,7 Fred H Geisler8

1The Spine Center, University of Colorado Hospital, Denver, CO, 2Spine Institute of Louisiana, Shreveport, LA, 3Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven, CT, 4Performance Spine and Sports Physicians, PC, Pottstown, PA, 5Texas Back Institute, Denton, TX, 6Department of Neurological Surgery, Stony Brook Medicine, Stony Brook, NY, 7Jon Block, Ph.D. San Francisco, CA, 8McLaren Hospital, Petoskey, MI, USA

Purpose: This report provides the 3-year clinical outcomes from the randomized, controlled US Food and Drug Administration Investigational Device Exemption trial of the Superion® for the treatment of moderate degenerative lumbar spinal stenosis.
Patients and methods: The Superion® was evaluated in the treatment of subjects aged 45 years or older suffering from symptoms of intermittent neurogenic claudication, secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5. Patients were treated between June 2008 and December 2011 at 31 investigational sites. Three hundred ninety-one subjects were included in the randomized study group consisting of 190 Superion® and 201 X-STOP® control subjects. The primary composite endpoint was individual patient success based on four components: improvement in two of three domains of the Zurich Claudication Questionnaire, no reoperations at the index level, no major implant/procedure-related complications, and no clinically significant confounding treatments.
Results: At 3 years, the proportion of subjects achieving the primary composite endpoint was greater for Superion® (63/120, 52.5%) than for X-STOP® (49/129, 38.0%) (P=0.023) and the corresponding success rates exceeded 80% for each of the individual components of the primary endpoint in the Superion® group (range: 81%–91%). Improvements in back and leg pain severity as well as back- and disease-specific functional outcomes were also maintained through 36 months.
Conclusion: The 3-year outcomes from this randomized controlled trial demonstrate durable clinical improvement consistently across all clinical outcomes for the Superion® in the treatment of patients with moderate degenerative lumbar spinal stenosis.

Keywords: InterSpinous Spacer, lumbar spinal stenosis, Superion®, neurogenic claudication

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]


Other articles by this author:

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

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

Clinical Interventions in Aging 2017, 12:1409-1417

Published Date: 6 September 2017

Vacuum-assisted cesarean section

McQuivey RW, Block JE

International Journal of Women's Health 2017, 9:151-155

Published Date: 7 March 2017

Facial fat grafting with a prototype injection control device

Hetherington HE, Block JE

Clinical, Cosmetic and Investigational Dermatology 2013, 6:201-209

Published Date: 13 September 2013

Axial lumbar interbody fusion: a 6-year single-center experience

Zeilstra DJ, Miller LE, Block JE

Clinical Interventions in Aging 2013, 8:1063-1069

Published Date: 12 August 2013

TranS1 VEO system: a novel psoas-sparing device for transpsoas lumbar interbody fusion

Hardenbrook MA, Miller LE, Block JE

Medical Devices: Evidence and Research 2013, 6:91-95

Published Date: 4 June 2013

The KineSpring® Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis

Clifford AG, Gabriel SM, O’ Connell M, Lowe D, Miller LE, Block JE

Medical Devices: Evidence and Research 2013, 6:69-76

Published Date: 17 May 2013

Successful two-stage revision of a KineSpring® joint unloading implant: a case study

Bowditch M, Miller LE, Block JE

International Medical Case Reports Journal 2012, 5:91-95

Published Date: 12 December 2012

Facet-sparing lumbar decompression with a minimally invasive flexible MicroBlade Shaver® versus traditional decompression: quantitative radiographic assessment

Lauryssen C, Berven S, Mimran R, Summa C, Sheinberg M, Miller LE, Block JE

Clinical Interventions in Aging 2012, 7:257-266

Published Date: 20 July 2012

Rationale, characteristics, and clinical performance of the OsteoSponge®: a novel allograft for treatment of osseous defects

Miller LE, Jacofsky DJ, Kirker KR, Fitzpatrick KL, Juda GA, Block JE

Orthopedic Research and Reviews 2012, 4:9-17

Published Date: 3 April 2012

Clinical utility of ultrasound guidance for intra-articular knee injections: a review

Berkoff DJ, Miller LE, Block JE

Clinical Interventions in Aging 2012, 7:89-95

Published Date: 20 March 2012

Percutaneous vertebral augmentation for painful osteolytic vertebral metastasis: a case report

Anselmetti GC, Tutton SM, Facchini FR, Miller LE, Block JE

International Medical Case Reports Journal 2012, 5:13-17

Published Date: 20 March 2012

Readers of this article also read:

Hematuria following Botox treatment for upper limb spasticity: a case report

Lo TC, Yeung ST, Lee S, Chang EY

Journal of Pain Research 2015, 8:619-622

Published Date: 14 September 2015

The impact of hearing loss on language performance in older adults with different stages of cognitive function

Lodeiro-Fernández L, Lorenzo-López L, Maseda A, Núñez-Naveira L, Rodríguez-Villamil JL, Millán-Calenti JC

Clinical Interventions in Aging 2015, 10:695-702

Published Date: 9 April 2015

Green synthesis of water-soluble nontoxic polymeric nanocomposites containing silver nanoparticles

Prozorova GF, Pozdnyakov AS, Kuznetsova NP, Korzhova SA, Emel’yanov AI, Ermakova TG, Fadeeva TV, Sosedova LM

International Journal of Nanomedicine 2014, 9:1883-1889

Published Date: 16 April 2014

Methacrylic-based nanogels for the pH-sensitive delivery of 5-Fluorouracil in the colon

Ashwanikumar N, Kumar NA, Nair SA, Kumar GS

International Journal of Nanomedicine 2012, 7:5769-5779

Published Date: 15 November 2012

Cross-linked acrylic hydrogel for the controlled delivery of hydrophobic drugs in cancer therapy

Deepa G, Thulasidasan AK, Anto RJ, Pillai JJ, Kumar GS

International Journal of Nanomedicine 2012, 7:4077-4088

Published Date: 27 July 2012

Crystallization after intravitreal ganciclovir injection

Pitipol Choopong, Nattaporn Tesavibul, Nattawut Rodanant

Clinical Ophthalmology 2010, 4:709-711

Published Date: 14 July 2010