Interspinous process device versus conventional decompression for lumbar spinal stenosis: 5-year results of a randomized controlled trial

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  • 1 Department of Neurosurgery and
  • | 2 Department of Biostatistics, Leiden University Medical Center, Leiden, The Netherlands;
  • | 3 Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands;
  • | 4 Department of Neurosurgery, HAGA Teaching Hospital, The Hague, The Netherlands; and
  • | 5 Department of Neurosurgery, Spaarne Hospital, Hoofddorp/Haarlem, The Netherlands
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OBJECTIVE

Interspinous process distraction devices (IPDs) can be implanted to treat patients with intermittent neurogenic claudication (INC) due to lumbar spinal stenosis. Short-term results provided evidence that the outcomes of IPD implantation were comparable to those of decompressive surgery, although the reoperation rate was higher in patients who received an IPD. This study focuses on the long-term results.

METHODS

Patients with INC and spinal stenosis at 1 or 2 levels randomly underwent either decompression or IPD implantation. Patients were blinded to the allocated treatment. The primary outcome was the Zurich Claudication Questionnaire (ZCQ) score at 5-year follow-up. Repeated measurement analysis was applied to compare outcomes over time.

RESULTS

In total, 159 patients were included and randomly underwent treatment: 80 patients were randomly assigned to undergo IPD implantation, and 79 underwent spinal bony decompression. At 5 years, the success rates in terms of ZCQ score were similar (68% of patients who underwent IPD implantation had a successful recovery vs 56% of those who underwent bony decompression, p = 0.422). The reoperation rate at 2 years after surgery was substantial in the IPD group (29%), but no reoperations were performed thereafter. Long-term visual analog scale score for back pain was lower in the IPD group than the bony decompression group (p = 0.02).

CONCLUSIONS

IPD implantation is a more expensive alternative to decompressive surgery for INC but has comparable functional outcome during follow-up. The risk of reoperation due to absence of recovery is substantial in the first 2 years after IPD implantation, but if surgery is successful this positive effect remains throughout long-term follow-up. The IPD group had less back pain during long-term follow-up, but the clinical relevance of this finding is debatable.

ABBREVIATIONS

Felix = Foraminal Enlargement Lumbar Interspinous distraXion; INC = intermittent neurogenic claudication; IPD = interspinous process distraction device; LSS = lumbar spinal stenosis; LTFU = lost to follow-up; OR = odds ratio; RMDQ = modified Roland-Morris Disability Questionnaire; VAS = visual analog scale; ZCQ = Zurich Claudication Questionnaire.

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  • 1

    Ishimoto Y, Yoshimura N, Muraki S, Yamada H, Nagata K, Hashizume H, et al. Prevalence of symptomatic lumbar spinal stenosis and its association with physical performance in a population-based cohort in Japan: the Wakayama Spine Study. Osteoarthritis Cartilage. 2012;20(10):11031108.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 2

    Johnsson KE, Udén A, Rosén I. The effect of decompression on the natural course of spinal stenosis. A comparison of surgically treated and untreated patients. Spine (Phila Pa 1976).1991;16(6):615619.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3

    Johnsson KE, Rosén I, Udén A. The natural course of lumbar spinal stenosis. Acta Orthop Scand Suppl. 1993;251:6768.

  • 4

    Malmivaara A, Slätis P, Heliövaara M, Sainio P, Kinnunen H, Kankare J, et al. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine (Phila Pa 1976).2007;32(1):18.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 5

    Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358(8):794810.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6

    Turner JA, Ersek M, Herron L, Deyo R. Surgery for lumbar spinal stenosis. Attempted meta-analysis of the literature. Spine (Phila Pa 1976).1992;17(1):18.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 7

    Airaksinen O, Herno A, Kaukanen E, Saari T, Sihvonen T, Suomalainen O. Density of lumbar muscles 4 years after decompressive spinal surgery. Eur Spine J. 1996;5(3):193197.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8

    Thomé C, Zevgaridis D, Leheta O, Bäzner H, Pöckler-Schöniger C, Wöhrle J, Schmiedek P. Outcome after less-invasive decompression of lumbar spinal stenosis: a randomized comparison of unilateral laminotomy, bilateral laminotomy, and laminectomy. J Neurosurg Spine. 2005;3(2):129141.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9

    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).2013;38(18):15291539.

    • Search Google Scholar
    • Export Citation
  • 10

    Fox MW, Onofrio BM, Onofrio BM, Hanssen AD. Clinical outcomes and radiological instability following decompressive lumbar laminectomy for degenerative spinal stenosis: a comparison of patients undergoing concomitant arthrodesis versus decompression alone. J Neurosurg. 1996;85(5):793802.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11

    Fox MW, Onofrio BM. Indications for fusion following decompression for lumbar spinal stenosis. Neurosurg Focus. 1997;3(2):e2.

  • 12

    Senegas J. [Surgery of the intervertebral ligaments, alternative to arthrodesis in the treatment of degenerative instabilities]. Acta Orthop Belg. 1991;57(suppl 1):221226.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13

    Sénégas J. Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments: the Wallis system. Eur Spine J. 2002;11(suppl 2):S164S169.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 14

    Chiu JC. Interspinous process decompression (IPD) system (X-STOP) for the treatment of lumbar spinal stenosis. Surg Technol Int. 2006;15:265275.

  • 15

    Moojen WA, Arts MP, Bartels RH, Jacobs WC, Peul WC. Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis. Eur Spine J. 2011;20(10):15961606.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16

    Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, 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):2231.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17

    Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, et al. 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 (Phila Pa 1976).2005;30(12):13511358.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 18

    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):463471.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19

    Eichholz KM, Fessler RG. Is the X STOP interspinous implant a safe and effective treatment for neurogenic intermittent claudication? Nat Clin Pract Neurol. 2006;2(1):2223.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20

    Moojen WA, Arts MP, Jacobs WC, van Zwet EW, van den Akker-van Marle ME, Koes BW, et al. Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ. 2013;347:f6415.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21

    Moojen WA, Arts MP, Jacobs WCH, van Zwet EW, van den Akker-van Marle ME, Koes BW, et al. IPD without bony decompression versus conventional surgical decompression for lumbar spinal stenosis: 2-year results of a double-blind randomized controlled trial. Eur Spine J. 2015;24(10):22952305.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22

    Moojen WA, Schenck CD, Lycklama À Nijeholt GJ, Jacobs WCH, Van der Kallen BF, Arts MP, et al. Preoperative MRI in patients with intermittent neurogenic claudication: relevance for diagnosis and prognosis. Spine (Phila Pa 1976).2018;43(5):348355.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 23

    Stucki G, Liang MH, Fossel AH, Katz JN. Relative responsiveness of condition-specific and generic health status measures in degenerative lumbar spinal stenosis. J Clin Epidemiol. 1995;48(11):13691378.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24

    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).1996;21(7):796803.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 25

    Tuli SK, Yerby SA, Katz JN. Methodological approaches to developing criteria for improvement in lumbar spinal stenosis surgery. Spine (Phila Pa 1976).2006;31(11):12761280.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 26

    Deyo RA, Diehl AK. Patient satisfaction with medical care for low-back pain. Spine (Phila Pa 1976).1986;11(1):2830.

  • 27

    Deyo RA, Patrick DL. The significance of treatment effects: the clinical perspective. Med Care. 1995;33(4 suppl):AS286AS291.

  • 28

    Hutchinson PJ, Laing RJ, Waran V, Hutchinson E, Hollingworth W. Assessing outcome in lumbar disc surgery using patient completed measures. Br J Neurosurg. 2000;14(3):195199.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 29

    Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006;332(7555):14301434.

  • 30

    Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life. Med Care. 1989;27(3 suppl):S217S232.

  • 31

    Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality of life in patients with sciatica. Spine (Phila Pa 1976).1995;20(17):18991909.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 32

    Roland M, Morris R. A study of the natural history of low-back pain. Part II: Development of guidelines for trials of treatment in primary care. Spine (Phila Pa 1976).1983;8(2):145150.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 33

    Roland M, Morris R. A study of the natural history of back pain. Part I: Development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976).1983;8(2):141144.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 34

    Schoppink LE, van Tulder MW, Koes BW, Beurskens SA, de Bie RA. Reliability and validity of the Dutch adaptation of the Quebec Back Pain Disability Scale. Phys Ther. 1996;76(3):268275.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 35

    Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983;16(1):87101.

  • 36

    Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975;1(3):277299.

  • 37

    Melzack R. The McGill Pain Questionnaire: from description to measurement. Anesthesiology. 2005;103(1):199202.

  • 38

    Sullivan GM, Artino AR Jr. Analyzing and interpreting data from Likert-type scales. J Grad Med Educ. 2013;5(4):541542.

  • 39

    Ostelo RWJG, de Vet HCW. Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol. 2005;19(4):593607.

  • 40

    van Geest S, Kuijper B, Oterdoom M, van den Hout W, Brand R, Stijnen T, et al. CASINO: surgical or nonsurgical treatment for cervical radiculopathy, a randomised controlled trial. BMC Musculoskelet Disord. 2014;15:129.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 41

    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;12:14091417.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 42

    Weber C, Giannadakis C, Rao V, Jakola AS, Nerland U, Nygaard ØP, et al. Is there an association between radiological severity of lumbar spinal stenosis and disability, pain, or surgical outcome?: A multicenter observational study. Spine (Phila Pa 1976).2016;41(2):E78E83.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 43

    Strömqvist BH, Berg S, Gerdhem P, Johnsson R, Möller A, Sahlstrand T, et al. X-Stop versus decompressive surgery for lumbar neurogenic intermittent claudication. Spine (Phila Pa 1976).2013;38(17):14361442.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 44

    Lønne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, Nygaard ØP. Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976).2015;40(2):7785.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 45

    Richter A, Halm HF, Hauck M, Quante M. 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. 2014;27(6):336341.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation

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