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Medical Devices: Evidence and Research Volume 12, 2019 - Issue
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Original Research

Interspinous Process Decompression With The Superion® Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry

Gene Tekmyster1 The Orthopaedic and Sports Medicine Center, Trumbull, CT06611, USA
,
Dawood Sayed2 The Center of Neuromodulation, The University of Kansas Health System, Kansas City, KS66103, USA
,
Kevin D Cairns3 Florida Spine Specialists, Ft. Lauderdale, FL33308, USA
,
Louis J Raso4 Jupiter Interventional Pain Management, Jupiter, FL33477, USA
,
Christopher Kim5 The Center for Pain Relief, Charleston, WV25304, USAORCID Iconhttps://orcid.org/0000-0001-8520-5694
ORCID Icon &
Jon E Block6 Independent Clinical Consultant, San Francisco, CA94115, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-9954-8938
ORCID Icon
Pages 423-427 | Published online: 03 Oct 2019

References

  • 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. Clin Interv Aging. 2017;12:1409–1417. doi:10.2147/CIA.S14350328919727
  • Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH. Interspinous process decompression improves quality of life in patients with lumbar spinal stenosis. Minim Invasive Surg. 2018;2018:1035954.30057811
  • Nunley PD, Deer TR, Benyamin RM, Staats PS, Block JE. Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis. J Pain Res. 2018;11:2943–2948. doi:10.2147/JPR.S18232230538533
  • Hoque DME, Kumari V, Hoque M, Ruseckaite R, Romero L, Evans SM. Impact of clinical registries on quality of patient care and clinical outcomes: a systematic review. PLoS One. 2017;12(9):e0183667. doi:10.1371/journal.pone.018366728886607
  • Krucoff MW, Sedrakyan A, Normand SL. Bridging unmet medical device ecosystem needs with strategically coordinated registries networks. JAMA. 2015;314(16):1691–1692. doi:10.1001/jama.2015.1103626302152
  • Loguidice V, Bini W, Shabat S, Miller LE, Block JE. Rationale, design and clinical performance of the superion(R) interspinous spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. Expert Rev Med Devices. 2011;8(4):419–426. doi:10.1586/erd.11.2421728727
  • Patel VV, Whang PG, Haley TR, et al. Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial. Spine (Phila Pa 1976). 2015;40(5):275–282. doi:10.1097/BRS.000000000000073525494323
  • Tomkins-Lane C, Melloh M, Lurie J, et al. ISSLS prize winner: consensus on the clinical diagnosis of lumbar spinal stenosis: results of an International Delphi study. Spine (Phila Pa 1976). 2016;41(15):1239–1246.26839989
  • Miller LE, Block JE. Interspinous spacer implant in patients with lumbar spinal stenosis: preliminary results of a multicenter, randomized, controlled trial. Pain Res Treat. 2012;2012:823509.22448323
  • Blumenthal S. The use of clinical registries in the United States: a landscape survey. EGEMS (Wash DC). 2017;5(1):26.29930965

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