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Research ArticleFull Length Article
Open Access

Does 360° lumbar spinal fusion improve long-term clinical outcomes after failure of conservative treatment in patients with functionally disabling single-level degenerative lumbar disc disease? Results of 5-year follow-up in 75 postoperative patients

Jack E. Zigler and Rick B. Delamarter
International Journal of Spine Surgery January 2013, 7 e1-e7; DOI: https://doi.org/10.1016/j.ijsp.2013.01.001
Jack E. Zigler
aTexas Back Institute, Plano, TX
MD
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  • For correspondence: jackzigler@juno.com
Rick B. Delamarter
bSpine Research Foundation, Santa Monica, CA
cCedars-Sinai Spine Center, Beverly Hills, CA
MD
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  • Article
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Article Figures & Data

Tables

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    Table 1

    Patient treatment allocation and follow-up

    Description
    Allocation93 were enrolled
    75 received intervention
    18 did not receive intervention
    • 2 denied insurance coverage

    • 8 changed their minds

    • 3 were no longer surgical candidates at time of surgery

    • 5 were treated off protocol

    2 y73 were evaluated (97.1% follow-up)
    • 2 secondary surgical interventions (included in primary composite endpoint, excluded from secondary analyses)

    2 missed visits (excluded from analysis)
    5 y56 were evaluated (74.7% follow-up)
    • 5 secondary surgical interventions (included in primary composite endpoint, excluded from secondary analyses)

    19 missed visits (excluded from analysis)
    • 1 death

    • 18 were lost to follow-up

    • View popup
    Table 2

    Demographics and baseline characteristics of all patients enrolled and treated on protocol

    Data (n 75)
    Age at surgery [mean (SD)] (y)40.4 (7.6)
    Male [n (%)]34 (45.3%)
    Race [n (%)]
     White59 (78.7%)
     African American5 (6.7%)
     Hispanic10 (13.3%)
    Asian American0 (0.0%)
     Other1 (1.3%)
    Smoking status
     Never34 (45.3%)
     Former17 (22.7%)
     Current24 (32.0%)
    Body mass index [mean (SD)] (kg/m2)27.3 (4.4)
    ODI score [mean (SD)] (out of 100)62.7 (10.3)
    Narcotic use as prior treatment [n (%)]57 (76.0%)
    Engaged in recreational activity [n (%)]37 (49.3%)
    Implant level [n (%)]
     L3-L43 (4.0%)
     L4-L522 (29.3%)
     L5-S150 (66.7%)
    Prior surgical treatment [n (%)]23 (30.7%)
    • NOTE. Continuous and ordinal variables were analyzed by a Wilcoxon rank sum test; categorical variables were analyzed with the Fisher exact test to compare Fusion single level Randomized patients (F1R) with Pro- Disc-L single level Randomized patients (P1R).

    • View popup
    Table 3

    ODI scores at baseline, 2 years, and 5 years

    ODI score
    nMean (SD)% Change (SD)
    Baseline7562.7 (10.3)—
    2 y7139.8 (24.3)−37.8% (36.0%)
    5 y5136.2 (25.7)−43.8% (37.1%)
    • NOTE. The Wilcoxon test was used to compare baseline data; t tests were used to compare 24- and 60-month percent improvement.

    • View popup
    Table 4

    SF-36 PCS scores

    SF-36 PCS score
    nMean (SD)% Change (SD)
    Baseline7430.9 (5.6)—
    2 y7038.8 (11.3)29.8% (40.9%)
    5 y5140.1 (13.6)29.9% (43.7%)
    • NOTE. The Wilcoxon test was used to compare baseline data; tests were used to compare 2-and 5-year percent improvement

    • View popup
    Table 5

    Radiographic outcomes at 5 years

    No. of patients
    No device migration45/45 (100.0%)
    No device subsidence45/45 (100.0%)
    Disc height decrease ≤3 mm41/45 (91.1%)
    Fusion status43/45 (95.6%)
    No radiolucency45/45 (100.0%)
    Range of motion44/44* (100.0%)
    • ↵* One fusion patient was missing extension radiographs.

    • View popup
    Table 6

    Patient pain assessment using 100-mm VAS

    VAS pain score
    nMean (SD)% Change (SD)
    Baseline7374.9 (14.7)—
    2 y7143.3 (31.6)−42.4% (42.9%)
    5 y5140.0 (32.1)−47.5% (43.8%)
    • NOTE. The Wilcoxon test was used to compare baseline data; tests were used to compare 24-and 60-month percent improvement.

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1 Jan 2013
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Does 360° lumbar spinal fusion improve long-term clinical outcomes after failure of conservative treatment in patients with functionally disabling single-level degenerative lumbar disc disease? Results of 5-year follow-up in 75 postoperative patients
Jack E. Zigler, Rick B. Delamarter
International Journal of Spine Surgery Jan 2013, 7 e1-e7; DOI: 10.1016/j.ijsp.2013.01.001

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Does 360° lumbar spinal fusion improve long-term clinical outcomes after failure of conservative treatment in patients with functionally disabling single-level degenerative lumbar disc disease? Results of 5-year follow-up in 75 postoperative patients
Jack E. Zigler, Rick B. Delamarter
International Journal of Spine Surgery Jan 2013, 7 e1-e7; DOI: 10.1016/j.ijsp.2013.01.001
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Keywords

  • degenerative disc disease
  • lumbar spine
  • 360° fusion
  • 5-year follow-up

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