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Research ArticleArticles

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

Michael J. Musacchio, Carl Lauryssen, Reginald J. Davis, Hyun W. Bae, John H. Peloza, Richard D. Guyer, Jack E. Zigler, Donna D. Ohnmeiss and Scott Leary
International Journal of Spine Surgery January 2016, 10 6; DOI: https://doi.org/10.14444/3006
Michael J. Musacchio
1Department of Neurosurgery, NorthShore University HealthSystem, Evanston, IL
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Carl Lauryssen
2NeuroTexas, Austin, TX
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Reginald J. Davis
3Laser Spine Institute, Philadelphia, PA
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Hyun W. Bae
4The Spine Institute, Santa Monica, CA
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John H. Peloza
5Texas Back Institute, Frisco, TX
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Richard D. Guyer
6Texas Back Institute, Plano, TX
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Jack E. Zigler
6Texas Back Institute, Plano, TX
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Donna D. Ohnmeiss
7Texas Back Institute Research Foundation, Plano, TX
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Scott Leary
8Senta Clinic, San Diego, CA
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Article Figures & Data

Figures

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  • Fig. 1
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    Fig. 1

    Among patients who were reoperated, the percentage of those reoperations in each of the annual time periods. In the D+ILS group, reoperations occurred earlier than in the D+PS group.

  • Fig. 2
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    Fig. 2

    Mean ODI scores improved significantly in both groups and remained improved throughout follow-up. Error bars represent the standard deviation.

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    Fig. 3

    Percentage of patients achieving ≥15 point decrease in ODI scores compared to baseline at each follow-up time point.

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    Fig. 4

    Mean VAS back pain scores (A) and worse leg pain scores (B) improved significantly in both groups and remained improved throughout follow-up. Error bars represent the standard deviation.

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    Fig. 5

    Zurich Claudication Questionnaire Scores on the symptom severity (A), physical function (B) and patient satisfaction (C) scales.

Tables

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    Table 1

    Month 60 overall efficacy of subjects achieving clinical success defined by the individual components of success.

    D+ILSD+PS
    Status pre-op compared with Month 60N assessedN meeting criterium%N assessedN meeting criterium%p-value
    Improvement of≥15 points in ODI at Month 60 compared to baseline12410080.6554174.5>0.40
    No reoperation or epidural steroid injection21514868.81077166.4>0.70
    No reoperations, revisions, removals, or supplemental fixation21517983.31078983.2>0.90
    No epidural injection at any lumbar level21517380.51078276.6>0.40
    No persistent new or increasing sensory or motor deficit888394.34040100.0>0.30
    No persistent new or increasing sensory deficit14814396.66666100.0>0.30
    No persistent new or increasing motor deficit14614498.6747297.3>0.60
    No major device-related complications21521298.610710295.3>0.10
    Composite Clinical Success (Month 60 CCS-FDA)1919650.3914044.0>0.30
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    Table 2

    Classification of reoperations/revisions by category.

    Reoperation CategoryD+ILS (N=215)
    n (%)
    D+PS (N=107)
    n (%)
    (1) Wound/surgery related7 (3.3%)1 (1.0%)
    (2) Under treatment5 (2.3%)2 (1.9%)
    (3) Device related issue6 (2.8%)7 (6.5%)
    (4) Device ineffective
     A. Early (≤ 2 years post-op)7 (3.3%)3 (2.8%)
     B. Late (> 2 years post-op)9 (4.2%)6 (5.6%)
    (5) Trauma1 (0.5%)0
    Total35 (16.3%)19 (17.8%)
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    Table 3

    Percentage of patients using narcotics to manage pain at each time point.

    Narcotics Usage
    D+ILS (%)
    n=215
    D+PS (%)
    n=107
    p (Fisher's Exact)
    Pre-op52.653.3>0.90
    Week 646.054.2>0.10
    Month 334.444.9>0.08
    Month 629.834.6>0.40
    Month 1228.038.3>0.40
    Month 1822.329.0>0.20
    Month 2423.333.6>0.06
    Month 3623.322.4>0.90
    Month 4823.720.6>0.50
    Month 6023.724.3>0.90
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International Journal of Spine Surgery
Vol. 10
1 Jan 2016
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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
Michael J. Musacchio, Carl Lauryssen, Reginald J. Davis, Hyun W. Bae, John H. Peloza, Richard D. Guyer, Jack E. Zigler, Donna D. Ohnmeiss, Scott Leary
International Journal of Spine Surgery Jan 2016, 10 6; DOI: 10.14444/3006

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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
Michael J. Musacchio, Carl Lauryssen, Reginald J. Davis, Hyun W. Bae, John H. Peloza, Richard D. Guyer, Jack E. Zigler, Donna D. Ohnmeiss, Scott Leary
International Journal of Spine Surgery Jan 2016, 10 6; DOI: 10.14444/3006
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Keywords

  • interlaminar device
  • spinal stenosis
  • lumbar spine
  • decompression
  • instrumented fusion
  • clinical outcome
  • randomized study

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