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01-10-2017 | Review

Interspinous process devices for the treatment of neurogenic intermittent claudication: a systematic review of randomized controlled trials

Authors: Mao Li, Huilin Yang, Genlin Wang

Published in: Neurosurgical Review | Issue 4/2017

Abstract

The aim of this study is to compare interspinous process device (IPD) implantation to other methods for the treatment of neurogenic intermittent claudication (NIC). PubMed and Cochrane library were searched in December 2014. Randomized controlled trials (RCTs) comparing IPD implantation and nonoperative therapy or laminectomy with/without spinal fusion for the treatment of NIC due to spinal stenosis or low-grade degenerative spondylolisthesis were included. Meta-analysis and qualitative analysis were conducted as appropriate. Eleven articles (eight RCTs) were included, with two having high risk of bias. These RCTs were divided into three groups according to control cohort interventions: IPD implantation was compared with nonoperative treatment (group 1, n = 3), laminectomy (group 2, n = 3), and laminectomy associated with instrumented spinal fusion (group 3, n = 2). Group 1 studies reported better Zurich Claudication Questionnaire (ZCQ) scores for the IPD group. In group 2, two studies reported comparable ZCQ scores and one revealed comparable visual analog scale (VAS) and Oswestry Disability Index (ODI) scores; pooled analysis showed a higher reoperation rate in patients treated with IPD. In group 3, one study found that more patients in IPD group gained more than 25 % improvement in VAS and ODI, with lower complication rate; the other reported better ZCQ scores in the IPD group and comparable complication and reoperation rates. IPD implantation is more effective than the other methods, but not superior to laminectomy in treating NIC.

Anderson PA, Tribus CB, Kitchel SH (2006) Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis. J Neurosurg Spine 4:463–471CrossRefPubMed

Azzazi A, Elhawary Y (2010) Dynamic stabilization using X-stop versus transpedicular screw fixation in the treatment of lumbar canal stenosis; comparative study of the clinical outcome. Neurosurg Q 20:165–169CrossRef

Celik H, Derincek A, Koksal I (2012) Surgical treatment of the spinal stenosis with an interspinous distraction device: do we really restore the foraminal height? Turk Neurosurg 22:50–54. doi:10.5137/1019-5149.JTN.4681-11.2 PubMed

Davis R, Auerbach JD, Bae H et al (2013) Can low-grade spondylolisthesis be effectively treated by either coflex interlaminar stabilization or laminectomy and posterior spinal fusion two-year clinical and radiographic results from the randomized, prospective, multicenter US investigational device exemption trial: clinical article. J Neurosurg Spine 19:174–184CrossRefPubMed

Davis RJ, Errico TJ, Bae H et al (2013) 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 38:1529–1539CrossRefPubMed

Deyo RA, Mirza SK, Martin BI et al (2010) Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 303:1259–1265. doi:10.1001/jama.2010.338 CrossRefPubMedPubMedCentral

Furlan AD, Pennick V, Bombardier C et al (2009) 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine 34:1929–1941. doi:10.1097/BRS.0b013e3181b1c99f CrossRefPubMed

Gazzeri R, Galarza M, Alfieri A (2014) Controversies about interspinous process devices in the treatment of degenerative lumbar spine diseases: past, present, and future. Biomed Res Int 2014:975052. doi:10.1155/2014/975052 CrossRefPubMedPubMedCentral

Gibson JN, Waddell G (2005) Surgery for degenerative lumbar spondylosis: updated Cochrane Review. Spine 30:2312–2320CrossRefPubMed

10.

Holinka J, Krepler P, Matzner M et al (2011) Stabilising effect of dynamic interspinous spacers in degenerative low-grade lumbar instability. Int Orthop 35:395–400. doi:10.1007/s00264-010-1017-5 CrossRefPubMed

11.

Hsu KY, Zucherman JF, Hartjen CA et al (2006) Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine 5:500–507. doi:10.3171/spi.2006.5.6.500 CrossRefPubMed

12.

Korovessis P, Repantis T, Zacharatos S et al (2009) Does Wallis implant reduce adjacent segment degeneration above lumbosacral instrumented fusion? Eur Spine J 18:830–840. doi:10.1007/s00586-009-0976-y CrossRefPubMedPubMedCentral

13.

Kovacs FM, Urrutia G, Alarcon JD (2011) Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine 36:E1335–E1351. doi:10.1097/BRS.0b013e31820c97b1 CrossRefPubMed

14.

Mardjetko SM, Connolly PJ, Shott S (1994) Degenerative lumbar spondylolisthesis. A meta-analysis of literature 1970–1993. Spine 19:2256S–2265SCrossRefPubMed

15.

Marsh GD, Mahir S, Leyte A (2014) A prospective randomised controlled trial to assess the efficacy of dynamic stabilisation of the lumbar spine with the Wallis ligament. Eur Spine J 23:2156–2160. doi:10.1007/s00586-014-3487-4 CrossRefPubMed

16.

Moojen WA, Arts MP, Jacobs WC et al (2013) Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ 347:f6415CrossRefPubMedPubMedCentral

17.

Porter RW (1996) Spinal stenosis and neurogenic claudication. Spine 21:2046–2052. doi:10.1097/BRS.0b013e31828ba413 CrossRefPubMed

18.

Postacchini R, Ferrari E, Cinotti G et al (2011) Aperius interspinous implant versus open surgical decompression in lumbar spinal stenosis. Spine J 11:933–939. doi:10.1016/j.spinee.2011.08.419 CrossRefPubMed

19.

Pratt RK, Fairbank JC, Virr A (2002) The reliability of the Shuttle Walking Test, the Swiss Spinal Stenosis Questionnaire, the Oxford Spinal Stenosis Score, and the Oswestry Disability Index in the assessment of patients with lumbar spinal stenosis. Spine 27:84–91CrossRefPubMed

20.

Puzzilli F, Gazzeri R, Galarza M et al (2014) 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 124:166–174. doi:10.1007/s00586-014-3487-4 CrossRefPubMed

21.

Richter A, Halm HF, Hauck M et al (2014) Two-year follow-up after decompressive surgery with and without implantation of an interspinous device for lumbar spinal stenosis: a prospective controlled study. J Spinal Disord Tech 27:336–341. doi:10.1097/BSD.0b013e31825f7203 CrossRefPubMed

22.

Richter A, Schutz C, Hauck M et al (2010) Does an interspinous device (Coflex) 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 19:283–289. doi:10.1007/s00586-009-1229-9 CrossRefPubMed

23.

Senegas J (2002) Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments: the Wallis system. Eur Spine J 11(Suppl 2):S164–S169. doi:10.1007/s00586-002-0423-9 PubMedPubMedCentral

24.

Sengupta DK, Herkowitz HN (2005) Degenerative spondylolisthesis: review of current trends and controversies. Spine 30:S71–S81CrossRefPubMed

25.

Sobottke R, Aghayev E, Roder C et al (2012) Predictors of surgical, general and follow-up complications in lumbar spinal stenosis relative to patient age as emerged from the Spine Tango Registry. Eur Spine J 21:411–417. doi:10.1007/s00586-011-2016-y CrossRefPubMed

26.

Sobottke R, Rollinghoff M, Siewe J et al (2010) Clinical outcomes and quality of life 1 year after open microsurgical decompression or implantation of an interspinous stand-alone spacer. Minim Invasive Neurosurg 53:179–183. doi:10.1055/s-0030-1263108 CrossRefPubMed

27.

Stromqvist B (2002) Evidence-based lumbar spine surgery. The role of national registration. Acta Orthop Scand Suppl 73:34–39CrossRefPubMed

28.

Stromqvist BH, Berg S, Gerdhem P et al (2013) X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine 38:1436–1442. doi:10.1097/BRS.0b013e31828ba413 CrossRefPubMed

29.

Stromqvist F, Jonsson B, Stromqvist B et al (2012) Dural lesions in decompression for lumbar spinal stenosis: incidence, risk factors and effect on outcome. Eur Spine J 21:825–828. doi:10.1007/s00586-011-2101-2 CrossRefPubMed

30.

Stucki G, Daltroy L, Liang MH et al (1996) Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine 21:796–803CrossRefPubMed

31.

Tamburrelli FC, Proietti L, Logroscino CA (2011) Critical analysis of lumbar interspinous devices failures: a retrospective study. Eur Spine J 20(Suppl 1):S27–S35. doi:10.1007/s00586-011-176-30 CrossRefPubMed

32.

Verhoof OJ, Bron JL, Wapstra FH et al (2008) High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis. Eur Spine J 17:188–192. doi:10.1007/s00586-007-0492-x CrossRefPubMed

33.

Zucherman JF, Hsu KY, Hartjen CA et al (2004) 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 13:22–31CrossRefPubMed

34.

Zucherman JF, Hsu KY, Hartjen CA et al (2005) 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. Spine 30:1351–1358CrossRefPubMed

Title: Interspinous process devices for the treatment of neurogenic intermittent claudication: a systematic review of randomized controlled trials
Authors: Mao Li
Huilin Yang
Genlin Wang
Publication date: 01-10-2017
Publisher: Springer Berlin Heidelberg
Published in: Neurosurgical Review / Issue 4/2017
Print ISSN: 0344-5607
Electronic ISSN: 1437-2320
DOI: https://doi.org/10.1007/s10143-016-0722-y

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Interspinous process devices for the treatment of neurogenic intermittent claudication: a systematic review of randomized controlled trials

Abstract

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