{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T19:23:54Z","timestamp":1790709834755,"version":"4.1.0"},"reference-count":23,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:sec><jats:title>OBJECTIVE<\/jats:title><jats:p>Surgical decompression is extremely effective in relieving pain and symptoms due to lumbar spinal stenosis (LSS). Decompression with interlaminar stabilization (D+ILS) is as effective as decompression with posterolateral fusion for stenosis, as shown in a major US FDA pivotal trial. This study reports a multicenter, randomized controlled trial in which D+ILS was compared with decompression alone (DA) for treatment of moderate to severe LSS.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Under approved institutional ethics review, 230 patients (1:1 ratio) randomized to either DA or D+ILS (coflex, Paradigm Spine) were treated at 7 sites in Germany. Patients had moderate to severe LSS at 1 or 2 adjacent segments from L-3 to L-5. Outcomes were evaluated up to 2 years postoperatively, including Oswestry Disability Index (ODI) scores, the presence of secondary surgery or lumbar injections, neurological status, and the presence of device- or procedure-related severe adverse events. The composite clinical success (CCS) was defined as combining all 4 of these outcomes, a success definition validated in a US FDA pivotal trial. Additional secondary end points included visual analog scale (VAS) scores, Z\u00fcrich Claudication Questionnaire (ZCQ) scores, narcotic usage, walking tolerance, and radiographs.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>The overall follow-up rate was 91% at 2 years. There were no significant differences in patient-reported outcomes at 24 months (p &gt; 0.05). The CCS was superior for the D+ILS arm (p = 0.017). The risk of secondary intervention was 1.75 times higher among patients in the DA group than among those in the D+ILS group (p = 0.055). The DA arm had 228% more lumbar injections (4.5% for D+ILS vs 14.8% for DA; p = 0.0065) than the D+ILS one. Patients who underwent DA had a numerically higher rate of narcotic use at every time point postsurgically (16.7% for D+ILS vs 23% for DA at 24 months). Walking Distance Test results were statistically significantly different from baseline; the D+ILS group had &gt; 2 times the improvement of the DA. The patients who underwent D+ILS had &gt; 5 times the improvement from baseline compared with only 2 times the improvement from baseline for the DA group. Foraminal height and disc height were largely maintained in patients who underwent D+ILS, whereas patients treated with DA showed a significant decrease at 24 months postoperatively (p &lt; 0.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>This study showed no significant difference in the individual patient-reported outcomes (e.g., ODI, VAS, ZCQ) between the treatments when viewed in isolation. The CCS (survivorship, ODI success, absence of neurological deterioration or device- or procedure-related severe adverse events) is statistically superior for ILS. Microsurgical D+ILS increases walking distance, decreases compensatory pain management, and maintains radiographic foraminal height, extending the durability and sustainability of a decompression procedure.<\/jats:p><jats:p>Clinical trial registration no.: NCT01316211 (clinicaltrials.gov)<\/jats:p><\/jats:sec>","DOI":"10.3171\/2017.11.spine17643","type":"journal-article","created":{"date-parts":[[2018,1,26]],"date-time":"2018-01-26T15:02:28Z","timestamp":1516978948000},"page":"406-415","source":"Crossref","is-referenced-by-count":47,"title":["Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization"],"prefix":"10.3171","volume":"28","author":[{"given":"Sven","family":"Schmidt","sequence":"first","affiliation":[{"name":"Orthop\u00e4dische Universit\u00e4tsklinik, Frankfurt;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joerg","family":"Franke","sequence":"additional","affiliation":[{"name":"Klinikum Magdeburg;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Rauschmann","sequence":"additional","affiliation":[{"name":"Orthop\u00e4dische Universit\u00e4tsklinik, Frankfurt;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dieter","family":"Adelt","sequence":"additional","affiliation":[{"name":"Paracelsusklinik Henstedt-Ulzburg;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo Mario","family":"Bonsanto","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Schleswig-Holstein Klinik f\u00fcr Neurochirurgie, Lubeck; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steffen","family":"Sola","sequence":"additional","affiliation":[{"name":"Chirurgische Universit\u00e4tsklinik Rostock, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1","series-title":"Int J Spine Surg","doi-asserted-by":"publisher","first-page":"15","DOI":"10.14444\/2015","article-title":"Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment","volume":"9","author":"Bae HW","year":"2015","unstructured":"Bae HW, Lauryssen C, Maislin G, Leary S, Musacchio MJ Jr: Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. Int J Spine Surg 9:15, 20152605663010.14444\/2015"},{"key":"b2","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"481","DOI":"10.1007\/s00586-016-4881-x","article-title":"Only walking matters\u2014assessment following lumbar stenosis decompression","volume":"26","author":"Budithi S","year":"2017","unstructured":"Budithi S, Dhawan R, Cattell A, Balain B, Jaffray D: Only walking matters\u2014assessment following lumbar stenosis decompression. Eur Spine J 26:481\u2013487, 20172790496410.1007\/s00586-016-4881-x"},{"key":"b3","series-title":"Spine (Phila Pa 1976)","first-page":"1529","article-title":"Decompression and Coflex interlaminar stabilization compared with 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 RJ","year":"2013","unstructured":"Davis RJ, Errico TJ, Bae H, Auerbach JD: Decompression and Coflex interlaminar stabilization compared with 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. Spine (Phila Pa 1976) 38:1529\u20131539, 201323680830"},{"key":"b4","series-title":"J Neurosurg","doi-asserted-by":"publisher","first-page":"27","DOI":"10.3171\/jns.1995.83.1.0027","article-title":"Measurement of exercise tolerance on the treadmill in patients with symptomatic lumbar spinal stenosis: a useful indicator of functional status and surgical outcome","volume":"83","author":"Deen HG Jr","year":"1995","unstructured":"Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM: Measurement of exercise tolerance on the treadmill in patients with symptomatic lumbar spinal stenosis: a useful indicator of functional status and surgical outcome. J Neurosurg 83:27\u201330, 1995778284510.3171\/jns.1995.83.1.0027"},{"key":"b5","series-title":"JAMA","doi-asserted-by":"publisher","first-page":"1259","DOI":"10.1001\/jama.2010.338","article-title":"Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults","volume":"303","author":"Deyo RA","year":"2010","unstructured":"Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG: Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 303:1259\u20131265, 201010.1001\/jama.2010.33820371784"},{"key":"b6","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1535","DOI":"10.1097\/00007632-199507000-00020","article-title":"Use of Oswestry Disability Index (ODI)","volume":"20","author":"Fairbank J","year":"1995","unstructured":"Fairbank J: Use of Oswestry Disability Index (ODI). Spine (Phila Pa 1976) 20:1535\u20131537, 1995862307810.1097\/00007632-199507000-00020"},{"key":"b7","series-title":"N Engl J Med","doi-asserted-by":"publisher","first-page":"1413","DOI":"10.1056\/NEJMoa1513721","article-title":"A randomized, controlled trial of fusion surgery for lumbar spinal stenosis","volume":"374","author":"F\u00f6rsth P","year":"2016","unstructured":"F\u00f6rsth P, \u00d3lafsson G, Carlsson T, Frost A, Borgstr\u00f6m F, Fritzell P, : A randomized, controlled trial of fusion surgery for lumbar spinal stenosis. N Engl J Med 374:1413\u20131423, 201610.1056\/NEJMoa151372127074066"},{"key":"b8","series-title":"N Engl J Med","doi-asserted-by":"publisher","first-page":"1424","DOI":"10.1056\/NEJMoa1508788","article-title":"Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis","volume":"374","author":"Ghogawala Z","year":"2016","unstructured":"Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, : Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis. N Engl J Med 374:1424\u20131434, 20162707406710.1056\/NEJMoa1508788"},{"key":"b9","series-title":"Int J Spine Surg","doi-asserted-by":"publisher","first-page":"41","DOI":"10.14444\/3041","article-title":"ISASS recommendations\/coverage criteria for decompression with interlaminar stabilization - coverage indications, limitations, and\/or medical necessity","volume":"10","author":"Guyer R","year":"2016","unstructured":"Guyer R, Musacchio M, Cammisa FP Jr, Lorio MP: ISASS recommendations\/coverage criteria for decompression with interlaminar stabilization - coverage indications, limitations, and\/or medical necessity. Int J Spine Surg 10:41, 20162837785510.14444\/3041"},{"key":"b10","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"388","DOI":"10.1007\/s00586-014-3592-4","article-title":"Comparative observational study of surgical outcomes of lumbar foraminal stenosis using minimally invasive microsurgical extraforaminal decompression alone versus posterior lumbar interbody fusion: a prospective cohort study","volume":"24","author":"Kim HJ","year":"2015","unstructured":"Kim HJ, Jeong JH, Cho HG, Chang BS, Lee CK, Yeom JS: Comparative observational study of surgical outcomes of lumbar foraminal stenosis using minimally invasive microsurgical extraforaminal decompression alone versus posterior lumbar interbody fusion: a prospective cohort study. Eur Spine J 24:388\u2013395, 201510.1007\/s00586-014-3592-425253301"},{"key":"b11","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1198","DOI":"10.1097\/BRS.0b013e31819fcf35","article-title":"The influence of preoperative back pain on the outcome of lumbar decompression surgery","volume":"34","author":"Kleinst\u00fcck FS","year":"2009","unstructured":"Kleinst\u00fcck FS, Grob D, Lattig F, Bartanusz V, Porchet F, Jeszenszky D, : The influence of preoperative back pain on the outcome of lumbar decompression surgery. Spine (Phila Pa 1976) 34:1198\u20131203, 200910.1097\/BRS.0b013e31819fcf3519407677"},{"key":"b12","series-title":"Asian Spine J","doi-asserted-by":"publisher","first-page":"161","DOI":"10.4184\/asj.2014.8.2.161","article-title":"Role of Coflex as an adjunct to decompression for symptomatic lumbar spinal stenosis","volume":"8","author":"Kumar N","year":"2014","unstructured":"Kumar N, Shah SM, Ng YH, Pannierselvam VK, Dasde S, Shen L: Role of Coflex as an adjunct to decompression for symptomatic lumbar spinal stenosis. Asian Spine J 8:161\u2013169, 20142476119810.4184\/asj.2014.8.2.161"},{"key":"b13","series-title":"Neurol Med Chir (Tokyo)","doi-asserted-by":"publisher","first-page":"870","DOI":"10.2176\/nmc.oa2012-0415","article-title":"Decompression only versus fusion surgery for lumbar stenosis in elderly patients over 75 years old: which is reasonable?","volume":"53","author":"Lee CH","year":"2013","unstructured":"Lee CH, Hyun SJ, Kim KJ, Jahng TA, Kim HJ: Decompression only versus fusion surgery for lumbar stenosis in elderly patients over 75 years old: which is reasonable? Neurol Med Chir (Tokyo) 53:870\u2013874, 201310.2176\/nmc.oa2012-041524172588"},{"key":"b14","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"591","DOI":"10.1097\/BRS.0b013e31828628f5","article-title":"Readmission rates after decompression surgery in patients with lumbar spinal stenosis among Medicare beneficiaries","volume":"38","author":"Modhia U","year":"2013","unstructured":"Modhia U, Takemoto S, Braid-Forbes MJ, Weber M, Berven SH: Readmission rates after decompression surgery in patients with lumbar spinal stenosis among Medicare beneficiaries. Spine (Phila Pa 1976) 38:591\u2013596, 20132332492310.1097\/BRS.0b013e31828628f5"},{"key":"b15","series-title":"BMJ","doi-asserted-by":"publisher","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 WA","year":"2013","unstructured":"Moojen WA, Arts MP, Jacobs WC, van Zwet EW, van den Akker-van Marle ME, Koes BW, : Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ 347:f6415, 20132423127310.1136\/bmj.f6415"},{"key":"b16","series-title":"Int J Spine Surg","doi-asserted-by":"publisher","first-page":"6","DOI":"10.14444\/3006","article-title":"Evaluation of decompression and interlaminar stabilization compared with decompression and fusion for the treatment of lumbar spinal stenosis: 5-year follow-up of a prospective, randomized, controlled trial","volume":"10","author":"Musacchio MJ","year":"2016","unstructured":"Musacchio MJ, Lauryssen C, Davis RJ, Bae HW, Peloza JH, Guyer RD, : Evaluation of decompression and interlaminar stabilization compared with decompression and fusion for the treatment of lumbar spinal stenosis: 5-year follow-up of a prospective, randomized, controlled trial. Int J Spine Surg 10:6, 20162691322610.14444\/3006"},{"key":"b17","series-title":"Asian Spine J","doi-asserted-by":"publisher","first-page":"521","DOI":"10.4184\/asj.2014.8.4.521","article-title":"Lumbar spinal stenosis: who should be fused? An updated review","volume":"8","author":"Omidi-Kashani F","year":"2014","unstructured":"Omidi-Kashani F, Hasankhani EG, Ashjazadeh A: Lumbar spinal stenosis: who should be fused? An updated review. Asian Spine J 8:521\u2013530, 20142518787310.4184\/asj.2014.8.4.521"},{"key":"b18","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1007\/s00586-009-1229-9","article-title":"Does an interspinous device (CoflexTM) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients","volume":"19","author":"Richter A","year":"2010","unstructured":"Richter A, Sch\u00fctz C, Hauck M, Halm H: Does an interspinous device (CoflexTM) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients. Eur Spine J 19:283\u2013289, 201010.1007\/s00586-009-1229-9"},{"key":"b19","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"2228","DOI":"10.1007\/s00586-015-4124-6","article-title":"Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study","volume":"24","author":"R\u00f6der C","year":"2015","unstructured":"R\u00f6der C, Baumg\u00e4rtner B, Berlemann U, Aghayev E: Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study. Eur Spine J 24:2228\u20132235, 201510.1007\/s00586-015-4124-626187621"},{"key":"b20","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"638","DOI":"10.1016\/j.spinee.2014.11.020","article-title":"Outcome of decompression with and without fusion in spinal stenosis with degenerative spondylolisthesis in relation to preoperative pain pattern: a register study of 1,624 patients","volume":"15","author":"Sigmundsson FG","year":"2015","unstructured":"Sigmundsson FG, J\u00f6nsson B, Str\u00f6mqvist B: Outcome of decompression with and without fusion in spinal stenosis with degenerative spondylolisthesis in relation to preoperative pain pattern: a register study of 1,624 patients. Spine J 15:638\u2013646, 20152545065310.1016\/j.spinee.2014.11.020"},{"key":"b21","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","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 G","year":"1996","unstructured":"Stucki G, Daltroy L, Liang MH, Lipson SJ, Fossel AH, Katz JN: Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine (Phila Pa 1976) 21:796\u2013803, 199610.1097\/00007632-199604010-000048779009"},{"key":"b22","series-title":"N Engl J Med","doi-asserted-by":"publisher","first-page":"794","DOI":"10.1056\/NEJMoa0707136","article-title":"Surgical versus nonsurgical therapy for lumbar spinal stenosis","volume":"358","author":"Weinstein JN","year":"2008","unstructured":"Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, : Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med 358:794\u2013810, 20081828760210.1056\/NEJMoa0707136"},{"key":"b23","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"450","DOI":"10.1007\/s00586-016-4587-0","article-title":"A comparison between different outcome measures based on \u201cmeaningful important differences\u201d in patients with lumbar spinal stenosis","volume":"26","author":"Wertli MM","year":"2017","unstructured":"Wertli MM, Buletti FC, Held U, Rasmussen-Barr E, Weiser S, Burgstaller JM, : A comparison between different outcome measures based on \u201cmeaningful important differences\u201d in patients with lumbar spinal stenosis. Eur Spine J 26:450\u2013461, 20172717746810.1007\/s00586-016-4587-0"}],"container-title":["Journal of Neurosurgery: Spine"],"original-title":[],"link":[{"URL":"https:\/\/thejns.org\/view\/journals\/j-neurosurg-spine\/28\/4\/article-p406.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/thejns.org\/downloadpdf\/journals\/j-neurosurg-spine\/28\/4\/article-p406.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/thejns.org\/downloadpdf\/journals\/j-neurosurg-spine\/28\/4\/article-p406.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,15]],"date-time":"2023-04-15T23:57:56Z","timestamp":1681603076000},"score":1,"resource":{"primary":{"URL":"https:\/\/thejns.org\/view\/journals\/j-neurosurg-spine\/28\/4\/article-p406.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,4]]},"references-count":23,"journal-issue":{"issue":"4"},"URL":"https:\/\/doi.org\/10.3171\/2017.11.spine17643","relation":{},"ISSN":["1547-5654"],"issn-type":[{"value":"1547-5654","type":"print"}],"subject":[],"published":{"date-parts":[[2018,4]]}}}