{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T17:51:39Z","timestamp":1786125099316,"version":"build-2736575974"},"reference-count":15,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","license":[{"start":{"date-parts":[[2017,6,26]],"date-time":"2017-06-26T00:00:00Z","timestamp":1498435200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/ mailto:journals.permissions@oup.com"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["NEUROSURGERY","NEUROS"],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>Standalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>To show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>A multicenter, international, randomized, controlled trial (RCT) was con- ducted. One hundred sixty-three patients, enrolled at 19 sites, were randomized 1:1 to treatment with IPD or SDS and were followed for 24 mo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      There was significant improvement in Zurich Claudication Questionnaire physical function, as mean percentage change from baseline, for both the IPD and the SDS groups at 12 mo (primary endpoint) and 24 mo (\u221232.3 \u00b1 32.1, \u221237.5 \u00b1 22.8; and \u221237.9 \u00b1 21.7%, \u221235.2 \u00b1 22.8, both\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .001). IPD treatment was not significantly noninferior (margin: 10%) to SDS treatment at 12 mo (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .172) but was significantly noninferior at 24 mo (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .005). Symptom severity, patient satisfaction, visual analog scale leg pain, and SF-36 improved in both groups over time. IPD showed lower mean surgical time and mean blood loss (24 \u00b1 11 min and 6 \u00b1 11 mL) compared to SDS (70 \u00b1 39 min and 189 \u00b1 148 mL, both\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .001). Reoperations at index level occurred in 18.2% of the patients in the IPD group and in 9.3% in the SDS group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Confirming 3 recent RCTs, we could show that IPD as well as open decompression achieve similar results in relieving symptoms of NIC in highly selected patients. However, despite some advantages in secondary outcomes, a higher reoperation rate for IPD is confirmed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/neuros\/nyx326","type":"journal-article","created":{"date-parts":[[2017,5,12]],"date-time":"2017-05-12T07:10:06Z","timestamp":1494573006000},"page":"621-629","source":"Crossref","is-referenced-by-count":31,"title":["Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?"],"prefix":"10.1227","volume":"82","author":[{"given":"Bernhard","family":"Meyer","sequence":"first","affiliation":[{"name":"Department of Neurosurgery, Klinikum rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adad","family":"Baranto","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Sahlgrenska University Hospital and Institute of Clinical Sciences at Sahlgrenska Academy University of Gothenburg, Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederic","family":"Schils","sequence":"additional","affiliation":[{"name":"Clinique St. Joseph, Li\u00e8ge, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederic","family":"Collignon","sequence":"additional","affiliation":[{"name":"Centre Neurochirurgical de Bruxelles Clinique du Parc Leopold, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bjorn","family":"Zoega","sequence":"additional","affiliation":[{"name":"Landspitali National University Hospital of Iceland, Reykjav\u00edk, Iceland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leong","family":"Tan","sequence":"additional","affiliation":[{"name":"Pacific Private Clinic, Benowa, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Charles","family":"LeHuec","sequence":"additional","affiliation":[{"name":"Service Ortho Rachis 2, P\u00f4le Chirurgie, CHU Pellegrin, Bordeaux, Universit\u00e9 de Bordeaux, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"NICE Trial Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2018,5]]},"reference":[{"issue":"8","key":"bib1-20231011","doi-asserted-by":"crossref","first-page":"1049","DOI":"10.1007\/s00586-008-0657-2","article-title":"Biomechanical effect of different lumbar interspinous implants on flexibility and intradiscal pressure","volume":"17","author":"Wilke","year":"2008","journal-title":"Eur Spine J"},{"issue":"18","key":"bib2-20231011","doi-asserted-by":"crossref","first-page":"1529","DOI":"10.1097\/BRS.0b013e31829a6d0a","article-title":"Decompression and Coflex interlaminar stabilization compared to decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter food and drug administration investigational device exemption trial","volume":"38","author":"Davis","year":"2013","journal-title":"Spine."},{"issue":"12","key":"bib3-20231011","doi-asserted-by":"crossref","first-page":"1351","DOI":"10.1097\/01.brs.0000166618.42749.d1","article-title":"A multicenter, prospective, randomized trial evaluating the X Stop interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results","volume":"30","author":"Zucherman","year":"2005","journal-title":"Spine."},{"key":"bib4-20231011","doi-asserted-by":"crossref","first-page":"f6415","DOI":"10.1136\/bmj.f6415","article-title":"Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial","volume":"347","author":"Moojen","year":"2013","journal-title":"BMJ."},{"issue":"17","key":"bib5-20231011","doi-asserted-by":"crossref","first-page":"1436","DOI":"10.1097\/BRS.0b013e31828ba413","article-title":"X-Stop versus decompressive surgery for lumbar neurogenic intermittent claudication: A randomized controlled trial with 2 years follow-up","volume":"38","author":"Str\u00f6mqvist","year":"2013","journal-title":"Spine."},{"issue":"2","key":"bib6-20231011","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1097\/BRS.0000000000000691","article-title":"Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study","volume":"40","author":"L\u00f8nne","year":"2015","journal-title":"Spine."},{"issue":"12","key":"bib7-20231011","doi-asserted-by":"crossref","first-page":"2565","DOI":"10.1007\/s00586-012-2330-z","article-title":"Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device Aperius in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication (INCA)","volume":"21","author":"Meirhaeghe","year":"2012","journal-title":"Eur Spine J."},{"issue":"7","key":"bib8-20231011","doi-asserted-by":"crossref","first-page":"796","DOI":"10.1097\/00007632-199604010-00004","article-title":"Measurement properties of a self-administered outcome measure in lumbar spinal stenosis","volume":"21","author":"Stucki","year":"1996","journal-title":"Spine"},{"issue":"2","key":"bib9-20231011","doi-asserted-by":"crossref","first-page":"188","DOI":"10.1007\/s00586-007-0492-x","article-title":"High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis","volume":"17","author":"Verhoof","year":"2008","journal-title":"Eur Spine J."},{"issue":"6","key":"bib10-20231011","doi-asserted-by":"crossref","first-page":"823","DOI":"10.1007\/s00586-009-0967-z","article-title":"Two year results of interspinous spacer (X-Stop) implantation in 175 patients with neurologic intermittent claudication due to lumbar spinal stenosis","volume":"18","author":"Kuchta","year":"2009","journal-title":"Eur Spine J."},{"issue":"11","key":"bib11-20231011","doi-asserted-by":"crossref","first-page":"1961","DOI":"10.1007\/s00701-010-0740-4","article-title":"Safety and efficacy of a new percutaneously implantable interspinous process device","volume":"152","author":"Kantelhardt","year":"2010","journal-title":"Acta Neurochir."},{"issue":"2","key":"bib12-20231011","doi-asserted-by":"crossref","first-page":"129","DOI":"10.3171\/spi.2005.3.2.0129","article-title":"Outcome after less-invasive decompression of lumbar spinal stenosis: a randomized comparison of unilateral laminotomy, bilateral laminotomy, and laminectomy","volume":"3","author":"Thom\u00e9","year":"2005","journal-title":"J Neurosurg Spine."},{"key":"bib13-20231011","article-title":"Treatment of lumbar spinal stenosis; comparison of two different surgical methods; mini-invasive decompression to X-stop (LSSS)","author":"L\u00f8nne"},{"issue":"7","key":"bib14-20231011","doi-asserted-by":"crossref","first-page":"531","DOI":"10.1097\/BRS.0b013e31827c99f0","article-title":"Risk for adjacent segment and same segment reoperation after surgery for lumbar stenosis: a subgroup analysis of the spine patient outcomes research trial (SPORT)","volume":"38","author":"Radcliff","year":"2013","journal-title":"Spine (Phila Pa 1976)."},{"issue":"22","key":"bib15-20231011","doi-asserted-by":"crossref","first-page":"2257","DOI":"10.1056\/NEJMoa070302","article-title":"Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis","volume":"356","author":"Weinstein","year":"2007","journal-title":"N Engl J Med."}],"container-title":["Neurosurgery"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/neurosurgery\/article-pdf\/82\/5\/621\/30245812\/nyx326.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ovid.com\/00006123-201805000-00005","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T16:50:16Z","timestamp":1786121416000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/00006123-201805000-00005"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,6,26]]},"references-count":15,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2018]]}},"URL":"https:\/\/doi.org\/10.1093\/neuros\/nyx326","relation":{},"ISSN":["0148-396X","1524-4040"],"issn-type":[{"value":"0148-396X","type":"print"},{"value":"1524-4040","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,6,26]]}}}