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Research ArticleLUMBAR ARTHROPLASTY
Open Access

Prospective, Randomized, Multicenter FDA IDE Study of CHARITÉ Artificial Disc versus Lumbar Fusion: Effect at 5-year Follow-up of Prior Surgery and Prior Discectomy on Clinical Outcomes Following Lumbar Arthroplasty

Fred H. Geisler, Paul C. McAfee, Robert J. Banco, Scott L. Blumenthal, Richard D. Guyer, Richard T. Holt and Mohamed E. Majd
International Journal of Spine Surgery January 2009, 3 (1) 17-25; DOI: https://doi.org/10.1016/SASJ-2008-0019-RR
Fred H. Geisler
aIllinois Neuro-Spine Center, 2020 Ogden Avenue, Suite 335, Aurora, IL 60504
MD, PhD
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Paul C. McAfee
bSpine and Scoliosis Center, Towson, MD 21204
MD
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Robert J. Banco
cBoston Spine Group, Boston, MA 02120
MD
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Scott L. Blumenthal
dTexas Back Institute, Plano, TX 75093
MD
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Richard D. Guyer
dTexas Back Institute, Plano, TX 75093
MD
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Richard T. Holt
eSpine Surgery, Louisville, KY 40202
MD
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Mohamed E. Majd
eSpine Surgery, Louisville, KY 40202
MD
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  • Article
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Article Figures & Data

Figures

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  • Figure 1
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    Figure 1

    Changes in VAS scores for arthroplasty (A) and fusion (B) patients, by time point. The “*” indicates statistical significance compared to the no prior surgery subgroups (ANG or FNG).

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    Figure 2

    Changes in ODI scores for arthroplasty (A) and fusion (B) patients, by time point. The “*” indicates statistical significance compared to the no prior surgery subgroups (ANG or FNG)

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    Figure 3

    Percentage of patients employed in full- or part-time jobs, by subgroups and time points.

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    Figure 4

    Percentage of patients who were “satisfied” or “somewhat satisfied” with the procedure at the various time points and by subgroups.

Tables

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    Table 1

    Demographic Information

    DemographicsArthroplastyFusion
    Prior SurgeryDiscectomyNo Prior SurgeryPrior SurgeryDiscectomyNo Prior Surgery
    Number of Subjects37215312631
    Gender
    Female14 (38%)9 (43%)29 (55%)6 (50%)3 (50%)13 (42%)
    Male23 (62%)12 (57%)24 (45%)6 (50%)3 (50%)18 (58%)
    Age (Years)
    Mean (Std)38.4 (8.48)40.1 (8.64)41.0 (8.57)35.3 (5.89)37.8 (5.56)40.2 (9.28)
    Median4043413638.542
    Min, Max19, 5520, 5521, 6025, 4328, 4325, 55
    Height (cm)
    Mean (Std)175.4 (8.72)174.5 (9.09)172.5 (9.86)172.5 (9.71)173.1 (10.46)173.8 (8.77)
    Median175.3175.3172.7174174172.7
    Min, Max157, 193157, 191150, 191155, 185155, 185157, 191
    Weight (kg)
    Mean (Std)80.8 (17.73)79.3 (17.59)79.4 (14.97)83.1 (14.04)80.8 (19.31)81.0 (16.71)
    Median81.681.280.786.28677.1
    Min, Max51, 12051, 12052, 11154, 10954, 10954, 118
    Body Mass Index
    Mean (Std)26.1 (4.45)25.9 (4.71)26.6 (3.92)28.1 (5.13)27.0 (6.31)26.7 (4.69)
    Median26.627.126.328.627.326.3
    Min, Max19, 3419, 3317, 3719, 3619, 3619, 40
    Targeted Level
    L4-510 (27%)4 (19%)16 (30%)5 (42%)3 (50%)5 (16%)
    L5-S127 (73%)17 (81%)37 (70%)7 (58%)3 (50%)26 (84%)
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    Table 2

    Surgical Data

    DemographicsArthroplastyFusion
    Prior SurgeryDiscectomyNo Prior SurgeryPrior SurgeryDiscectomyNo Prior Surgery
    N37215312631
    Total Surgery Time (Min)
    Mean (Std)97.5 (29.44)95.6 (29.42)115.6 (53.69)106.3 (66.58)81.8 (29.14)128.2 (66.23)
    Median8887997467.5115
    Min, Max56, 17556, 17545, 25055, 24862, 13760, 355
    Estimated Blood Loss (cc)
    Mean (Std)158.3 (143.3)145.2 (124.65)248.7 (277.81)251.6 (440.72)341.5 (618.46)186.0 (169.19)
    Median1001001507599.5150
    Min, Max50, 60050, 50025, 150050, 160050, 160020, 700
    Duration of Hospital Stay
    Mean (Std)3.7 (0.97)3.8(1.22)3.7(.86)4.3(2.50)3.5(0.55)4.3(1.47)
    Median44443.54
    Min, Max1, 61, 62, 63, 123, 42, 8
    • View popup
    Table 1

    Posterior Lumbar Fusions in the United States by Gender, 2004-2007

    By GenderCount%
    % Male8,73343.2%
    % Female11,47156.8%
    Total20,204100.0%
    • View popup
    Table 2

    Average Charges for Posterior Lumbar Fusion in the United States by Gender, 2004-2007

    By GenderCountAverage Charge
    Male8733$79,795
    Female11471$79,903
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    Table 3

    360 degree Lumbar Fusions in the United States by Gender, 2004-2007

    By GenderCount%
    % Male1,12141.9%
    % Female1,55258.1%
    Total2,673100.0%
    • View popup
    Table 4

    Average Charge for 360 degree Lumbar Fusions in the United States by Gender, 2004-2007

    By GenderCountAverage Charge
    % Male1,121$126,777
    % Female1,552$125,696
    • View popup
    Table 5

    Average Charges for Posterior Lumbar Fusions in the United States by Region, 2007

    RegionAverage Charge
    Northeast$79,785
    Midwest$79,401
    West$109,985
    South$93,169
    • View popup
    Table 6

    Average Charges for Posterior Lumbar Fusions in the United States by Year

    YearAverage Charge% Change
    2004$68,397
    2005$73,5277.5%
    2006$81,72811.2%
    2007$91,27511.7%
    • View popup
    Table 7

    Average Charges for 360 degree Lumbar Fusions in the United States by Year

    YearAverage Charge% Change
    2004$109,079
    2005$112,1512.8%
    2006$133,20318.8%
    2007$141,0565.9%
    • View popup
    Table 8

    Postoperative Complications by ICD-9 Code, Posterior Lumbar Fusion in the United States, 2004-2007

    Count%
    Total Posterior Lumbar Fusions 20,204
    Cardiac
    997.1, 410.0-410.9, 998.01480.73%
    Respiratory
    997.3, 415.1, 518.0-518.49654.78%
    Peripheral
    997.270.03%
    CNS
    997.0,997.00,997.01,997.092911.44%
    Hematoma
    998.1,998.11,998.12,998.136913.42%
    Accidental cut / hemorrage
    998.2, E870.06463.20%
    Complication of operative wound
    998.3,998.31,998.32,998.831250.62%
    Postoperative infection
    998.5,999.3,998.51,998.594462.21%
    Other unspecified complications
    998.8, 998.89,998.9,999.9,
    E8788,E8789
    4342.15%
    CSF leak
    349.0, 998.6570.28%
    Vertebral injury
    900.00, 900.01, 900.02, 900.03,
    900.82,900.89,900.9,997.02,954.0
    30.01%
    Mechanical Compliation of Implant or Graft
    996.4, 996.408884.40%
    • View popup
    Table 9

    Postoperative Complications, 360 degree Lumbar Fusion in the United States, 2004-2007

    Count%
    Total 360 Lumbar Fusions 2,673
    Cardiac
    997.1, 410.0-410.9, 998.0271.01%
    Respiratory*
    997.3, 415.1, 518.0-518.41786.66%
    Peripheral
    997.210.04%
    CNS
    997.0,997.00,997.01,997.09301.12%
    Hematoma
    998.1,998.11,998.12,998.131063.97%
    Accidental cut / hemorrage
    998.2, E870.01084.04%
    Complication of operative wound
    998.3,998.31,998.32,998.83200.75%
    Postoperative infection
    998.5,999.3,998.51,998.59481.80%
    Other unspecified complications
    998.8, 998.89,998.9,999.9,
    E8788,E8789712.66%
    CSF leak
    349.0, 998.610.04%
    Vertebral injury
    900.00, 900.01, 900.02, 900.03, 900.82,90
    0.89,900.9,997.02,954.010.04%
    Mechanical Complication of Implant or Graft
    996.4, 996.401746.51%
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International Journal of Spine Surgery
Vol. 3, Issue 1
1 Jan 2009
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Prospective, Randomized, Multicenter FDA IDE Study of CHARITÉ Artificial Disc versus Lumbar Fusion: Effect at 5-year Follow-up of Prior Surgery and Prior Discectomy on Clinical Outcomes Following Lumbar Arthroplasty
Fred H. Geisler, Paul C. McAfee, Robert J. Banco, Scott L. Blumenthal, Richard D. Guyer, Richard T. Holt, Mohamed E. Majd
International Journal of Spine Surgery Jan 2009, 3 (1) 17-25; DOI: 10.1016/SASJ-2008-0019-RR

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Prospective, Randomized, Multicenter FDA IDE Study of CHARITÉ Artificial Disc versus Lumbar Fusion: Effect at 5-year Follow-up of Prior Surgery and Prior Discectomy on Clinical Outcomes Following Lumbar Arthroplasty
Fred H. Geisler, Paul C. McAfee, Robert J. Banco, Scott L. Blumenthal, Richard D. Guyer, Richard T. Holt, Mohamed E. Majd
International Journal of Spine Surgery Jan 2009, 3 (1) 17-25; DOI: 10.1016/SASJ-2008-0019-RR
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