24-Month Outcomes of Indirect Decompression Using a Minimally Invasive Interspinous Fixation Device versus Standard Open Direct Decompression for Lumbar Spinal Stenosis: A Prospective Comparison

References

• Kirkaldy-Willis WH, Wedge JH, Yong-Hing K, Reilly J. Pathology and pathogenesis of lumbar spondylosis and stenosis. Spine. 1978;3(4):319–328. doi:10.1097/00007632-197812000-00004
   PubMedGoogle Scholar
• Binder DK, Schmidt MH, Weinstein PR. Lumbar spinal stenosis. Semin Neurol. 2002;22(2):157–166. doi:10.1055/s-2002-36539
   PubMed Web of Science ®Google Scholar
• Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007;356(22):2257–2270. doi:10.1056/NEJMoa070302
   PubMed Web of Science ®Google Scholar
• Zaina F, Tomkins-Lane C, Carragee E, Negrini S. Surgical versus nonsurgical treatment for lumbar spinal stenosis. Spine. 2016;41(14):E857–68. doi:10.1097/BRS.0000000000001635
   PubMed Web of Science ®Google Scholar
• Gazzeri R, Galarza M, Alfieri A. Controversies about interspinous process devices in the treatment of degenerative lumbar spine diseases: past, present, and future. Biomed Res Int. 2014;2014:1–15. doi:10.1155/2014/975052
   Web of Science ®Google Scholar
• Onggo JR, Nambiar M, Maingard JT, et al. The use of minimally invasive interspinous process devices for the treatment of lumbar canal stenosis: a narrative literature review. J Spine Surg. 2021;7(3):394–412. doi:10.21037/jss-21-57
   PubMedGoogle Scholar
• Anderson PA, Tribus CB, Kitchel SH. Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis. J Neurosurg Spine. 2006;4(6):463–471. doi:10.3171/spi.2006.4.6.463
   PubMed Web of Science ®Google Scholar
• Hsu KY, Zucherman JF, Hartjen CA, et al. Quality of life of lumbar stenosis–treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006;5(6):500–507. doi:10.3171/spi.2006.5.6.500
   PubMed Web of Science ®Google Scholar
• Zucherman JF, Hsu KY, Hartjen CA, et al. A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J. 2004;13(1):22–31. 10. doi:10.1007/s00586-003-0581-4
   PubMed Web of Science ®Google Scholar
• Zucherman JF, Hsu KY, Hartjen CA, et al. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication. Spine. 2005;30(12):1351–1358. doi:10.1097/01.brs.0000166618.42749.d1
   PubMed Web of Science ®Google Scholar
• Puzzilli F, Gazzeri R, Galarza M, et al. Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: a multicenter study with a minimum 3-year follow-up. Clin Neurol Neurosurg. 2014;124:166–174. doi:10.1016/j.clineuro.2014.07.004
   PubMed Web of Science ®Google Scholar
• Tram J, Srinivas S, Wali AR, Lewis CS, Pham MH. Decompression surgery versus interspinous devices for lumbar spinal stenosis: a systematic review of the literature. Asian Spine J. 2020;14(4):526–542. doi:10.31616/asj.2019.0105
   PubMed Web of Science ®Google Scholar
• Moojen WA, Arts MP, Jacobs WCH, et al. Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ. 2013;347(nov14 5):f6415–f6415. doi:10.1136/bmj.f6415
   PubMedGoogle Scholar
• Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH. Superion Interspinous Spacer Treatment of Moderate Spinal Stenosis: 4-Year Results. World Neurosurg. 2017;104:279–283. doi:10.1016/j.wneu.2017.04.163
   PubMed Web of Science ®Google Scholar
• Patil CG, Sarmiento JM, Ugiliweneza B, et al. Interspinous device versus laminectomy for lumbar spinal stenosis: a comparative effectiveness study. Spine J. 2014;14(8):1484–1492. doi:10.1016/j.spinee.2013.08.053
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence (UK). Low back pain and sciatica in over 16s: assessment and management (NG59). NICE Guideline; 2020 Available from: www.nice.org.uk/guidance/ng59. Accessed June 7, 2024.
   Google Scholar
• Oliveira L, Marchi L, Coutinho E, Pimenta L. A radiographic assessment of the ability of the extreme lateral interbody fusion procedure to indirectly decompress the neural elements. Spine. 2010;35(26S):S331–S337. doi:10.1097/BRS.0b013e3182022db0
   PubMedGoogle Scholar
• Vokshoor A, Khurana S, Wilson D, Filsinger P. Clinical and radiographic outcomes after spinous process fixation and posterior fusion in an elderly cohort. Surg Technol Int. 2014;25:271–276.
   PubMedGoogle Scholar
• Skoblar M, Hedman T, Rogers AJ, Jasper GP, Beall DP. Instrumented posterior arthrodesis of the lumbar spine: prospective study evaluating fusion outcomes in patients receiving an interspinous fixation device for the treatment of degenerative spine diseases. J Pain Res. 2023;16:2909–2918. doi:10.2147/JPR.S417319
   PubMed Web of Science ®Google Scholar
• Postacchini F, Postacchini R, Menchetti PPM, Sessa P, Paolino M, Cinotti G. Lumbar interspinous process fixation and fusion with stand-alone interlaminar lumbar instrumented fusion implant in patients with degenerative spondylolisthesis undergoing decompression for spinal stenosis. Asian Spine J. 2016;10(1):27–37. doi:10.4184/asj.2016.10.1.27
   PubMedGoogle Scholar
• Falowski SM, Mangal V, Pope J, et al. Multicenter retrospective review of safety and efficacy of a novel minimally invasive lumbar interspinous fusion device. J Pain Res. 2021;14:1525–1531. doi:10.2147/JPR.S304957
   PubMed Web of Science ®Google Scholar
• Chen M, Tang H, Shan J, et al. A new interspinous process distraction device BacFuse in the treatment of lumbar spinal stenosis with 5 years follow-up study. Medicine. 2020;99(26):e20925. doi:10.1097/MD.0000000000020925
   PubMed Web of Science ®Google Scholar
• Chin KR, Pencle FJR, Benny A, Seale JA. Greater than 5-year follow-up of outpatient L4−L5 lumbar interspinous fixation for degenerative spinal stenosis using the INSPAN device. J Spine Surg. 2020;6(3):549–554. doi:10.21037/jss-20-547
   PubMedGoogle Scholar
• Sclafani JA, Liang K, Ohnmeiss DD, Gordon C. Clinical outcomes of a polyaxial interspinous fusion system. Int J Spine Surg. 2014;8:35. doi:10.14444/1035
   PubMedGoogle Scholar
• Tatsumi R Single-level posterior lumbar fusion and decompression for degenerative spondylolisthesis - comparison between pedicle screws and spinous process fixation - up to two year follow-up. In: Congress of Neurological Surgeons 2012 Annual Meeting; 2012.
   Google Scholar
• Babu R, Gottfried ON, Stevenson JC. Outcomes and complications following spinous process fixation: a single-center analysis of 192 cases. Surg Technol Int. 2013;23:283–290.
   PubMedGoogle Scholar
• Hedman TP, Ohnmeiss DD, Leasure J, Raji OR, Hochschuler SH. Interspinous-interbody fusion via a strictly lateral surgical approach: a biomechanical stabilization comparison to constructs requiring both lateral and posterior approaches. Cureus. 2023;15(7):e41918. doi:10.7759/cureus.41918
   PubMed Web of Science ®Google Scholar
• Gillespie KA, Dickey JP. Biomechanical role of lumbar spine ligaments in flexion and extension: determination using a parallel linkage robot and a porcine model. Spine. 2004;29(11):1208–1216. doi:10.1097/00007632-200406010-00010
   PubMed Web of Science ®Google Scholar
• Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Spine. 1995;20(12):1410–1418. doi:10.1097/00007632-199506020-00014
   PubMed Web of Science ®Google Scholar
• Kuchta J, Sobottke R, Eysel P, Simons P. Two-year results of interspinous spacer (X-Stop) implantation in 175 patients with neurologic intermittent claudication due to lumbar spinal stenosis. Eur Spine J. 2009;18(6):823–829. doi:10.1007/s00586-009-0967-z
   PubMed Web of Science ®Google Scholar
• Ostelo RWJG, Deyo RA, Stratford P, et al. Interpreting Change Scores for Pain and Functional Status in Low Back Pain. Spine. 2008;33(1):90–94. doi:10.1097/BRS.0b013e31815e3a10
   PubMed Web of Science ®Google Scholar
• Siddiqui M, Smith FW, Wardlaw D. One-Year Results of X STOP Interspinous Implant for the Treatment of Lumbar Spinal Stenosis. Spine. 2007;32(12):1345–1348. doi:10.1097/BRS.0b013e31805b7694
   PubMed Web of Science ®Google Scholar
• Basil GW, Yang MY. Trends in outpatient minimally invasive spine surgery. J Spine Surg. 2019;5(Suppl1):S108–S114. doi:10.21037/jss.2019.04.17
   PubMedGoogle Scholar
• Lee J, Hida K, Seki T, Iwasaki Y, Minoru A. An interspinous process distractor (X STOP) for lumbar spinal stenosis in elderly patients – preliminary experiences in 10 consecutive cases. J Spinal Disord Tech. 2004;17(1):72–77. doi:10.1097/00024720-200402000-00013
   PubMedGoogle Scholar
• Richards JC, Majumdar S, Lindsey DP, Beaupre GS, Yerby SA. The treatment mechanism of an interspinous process implant for lumbar neurogenic intermittent claudication. Spine. 2005;30(7):744–749. doi:10.1097/01.brs.0000157483.28505.e3
   PubMed Web of Science ®Google Scholar
• Siddiqui M, Nicol M, Karadimas E, Smith F, Warlaw D. The positional magnetic resonance imaging changes in the lumbar spine following insertion of a novel interspinous process distraction device. Spine. 2005;30(23):2677–2682. doi:10.1097/01.brs.0000187878.79676.26
   PubMed Web of Science ®Google Scholar
• Patel VV, Whang PG, Haley TR, et al. Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis. Spine. 2015;40(5):275–282. doi:10.1097/BRS.0000000000000735
   PubMed Web of Science ®Google Scholar
• Kulkarni AG, Patel RS, Dutta S. Does minimally invasive spine surgery minimize surgical site infections? Asian Spine J. 2016;10(6):1000–1006.
   PubMedGoogle Scholar
• Kim CW. Scientific basis of minimally invasive spine surgery - prevention of multifidus muscle injury during posterior lumbar surgery. Spine. 2010;35(26S):S281–S286. doi:10.1097/BRS.0b013e3182022d32
   PubMedGoogle Scholar
• Tartara F, Garbossa D, Armocida D, et al. Relationship between lumbar lordosis, pelvic parameters, PI-LL mismatch and outcome after short fusion surgery for lumbar degenerative disease. Literature review, rational and presentation of public study protocol: rELApSE study (registry for Evaluation of Lumbar Arthrodesis Sagittal alignEment). World Neurosurg. 2023;18:100162. doi:10.1016/j.wnsx.2023.100162
   Google Scholar