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Research ArticleFull Length Article
Open Access

Two- to 3-Year Follow-Up of ProDisc-L: Results From a Prospective Randomized Trial of Arthroplasty Versus Fusion

Jack E. Zigler, Barton L. Sachs, Ralph F. Rashbaum and Donna D. Ohnmeiss
International Journal of Spine Surgery January 2007, 1 (2) 63-67; DOI: https://doi.org/10.1016/SASJ-2006-0003-RR
Jack E. Zigler
1The Texas Back Institute, Plano, Texas
MD
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Barton L. Sachs
1The Texas Back Institute, Plano, Texas
MD
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Ralph F. Rashbaum
1The Texas Back Institute, Plano, Texas
MD
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Donna D. Ohnmeiss
2The Texas Back Institute Research Foundation, Plano
Dr Med
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    Figure 1

    Mean Visual Analog Scale (VAS) scores assessing pain decreased significantly in both surgical groups by the 6-week follow-up visit and remained significantly less than the preoperative value throughout the remainder of the 36-month period. Although mean total disc replacement (TDR) VAS scores were less than the fusion scores at each follow-up period, differences were not statistically significant.

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    Figure 2

    Mean Oswestry Disability Index (ODI) scores decreased significantly in both surgical groups by the 6-week follow-up visit and remained significantly less than the preoperative value throughout the remainder of the 36- month period. Although mean total disc replacement (TDR) ODI scores were less than the fusion scores at each follow-up period, the difference was statistically significant only at the 3-month follow-up.

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    Figure 3

    Mean postoperative satisfaction scores (greater scores indicate greater satisfaction on a 0 to 10 VAS scale) were high in both groups. Mean scores in the total disc replacement (TDR) group were greater at all visits, but statistically significantly so at the 24-month follow-up (P < .05).

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    Figure 4

    Responses to the question “Remembering the pain you felt before your surgery, would you have this surgery again?” Values presented are the percentage of patients selecting the indicated response at each of the follow-up periods. At the 6-, 12-, 24-, and 36-month periods, the distribution of the responses was significantly more favorable in the ProDisc-L group (P < .05;χ2).

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    Table 1

    Summary of Study Population Characteristics: Total Disc Replacement (TDR) and Fusion Groups

    TDRFusion
    General
    Gender
     Male55.9%46.7%
     Female44.1%53.3%
    Mean age, years41.141.2
    Mean body mass index (kg/m2)27.027.0
    Pain duration
      < 1 year13.4%10.0%
      > 1 year86.6%90.0%
    Previous nonfusion spinal surgery37.0%23.3%
    Smoker32.3%43.3%
    Surgical
    Number of levels operated
     1 level60.6%53.3%
     2 levels39.4%46.7%
    Level(s) operated
     L3–L43.3%3.3%
     L4–L518.1%6.7%
     L5–S138.6%43.3%
     L3–L4 and L4–L53.1%6.7%
     L4–5 and L5–S136.9%40.0%
    • Note. No significant differences were observed (all Ps > .05).

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    Table 2

    Mean Operative Time, Blood Loss, and Length of Hospital Stay in the Total Disc Replacement (TDR) and Fusion Groups

    TDRFusion
    Operative time, minutes75.5232.3
    Estimated blood loss, mL81.4200.0
    Hospital stay, days2.053.33
    • Note. P < .01 (t test) for all comparisons.

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International Journal of Spine Surgery
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1 Jan 2007
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Two- to 3-Year Follow-Up of ProDisc-L: Results From a Prospective Randomized Trial of Arthroplasty Versus Fusion
Jack E. Zigler, Barton L. Sachs, Ralph F. Rashbaum, Donna D. Ohnmeiss
International Journal of Spine Surgery Jan 2007, 1 (2) 63-67; DOI: 10.1016/SASJ-2006-0003-RR

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Two- to 3-Year Follow-Up of ProDisc-L: Results From a Prospective Randomized Trial of Arthroplasty Versus Fusion
Jack E. Zigler, Barton L. Sachs, Ralph F. Rashbaum, Donna D. Ohnmeiss
International Journal of Spine Surgery Jan 2007, 1 (2) 63-67; DOI: 10.1016/SASJ-2006-0003-RR
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Keywords

  • artificial disc
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  • prospective study
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