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Research ArticleFull Length Article
Open Access

Cervical total disc replacement using a novel compressible prosthesis: Results from a prospective Food and Drug Administration–regulated feasibility study with 24-month follow-up

Carl Lauryssen, Domagoj Coric, Thomas Dimmig, David Musante, Donna D. Ohnmeiss and Harrison A. Stubbs
International Journal of Spine Surgery January 2012, 6 71-77; DOI: https://doi.org/10.1016/j.ijsp.2012.02.001
Carl Lauryssen
aInstitute for Advanced Spinal Research in California, Beverly Hills, CA
MD
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  • For correspondence: clauryssen@gmail.com
Domagoj Coric
bCarolina Neurosurgery and Spine Associates, Charlotte, NC
MD
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Thomas Dimmig
cTriangle Orthopaedic Associates, Durham, NC
MD
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David Musante
cTriangle Orthopaedic Associates, Durham, NC
MD
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Donna D. Ohnmeiss
dTexas Back Institute Research Foundation, Plano, TX
PhD
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Harrison A. Stubbs
eOakland, CA
PhD
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  • Article
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Article Figures & Data

Figures

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  • Fig. 1
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    Fig. 1

    Cutaway view of single-piece M6-C compressible prosthesis.

  • Fig. 2
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    Fig. 2

    Mean NDI through 24-month follow-up. (Pre-op, preoperatively.)

  • Fig. 3
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    Fig. 3

    Mean VAS scores for neck pain through follow-up. (Pre-op, preoperatively.)

  • Fig. 4
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    Fig. 4

    Mean VAS scores for right and left arm pain. (Pre-op, preoperatively.)

  • Fig. 5
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    Fig. 5

    Mean anterior and posterior disc space heights. (Pre-op, preoperatively.)

  • Fig. 6
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    Fig. 6

    Mean disc angle preoperatively through follow-up.

  • Fig. 7
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    Fig. 7

    Mean global and index-level ROM. (Pre-op, preoperatively.)

  • Fig. 8
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    Fig. 8

    Mean left/right lateral bending of implanted level. (Pre-op, preoperatively.)

  • Fig. 9
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    Fig. 9

    Flexion (A) and extension (B) radiographs of TDRs at C5-6 level with 8.4° of motion and at C6-7 level with 12.4°. The global motion was 39.6°.

Tables

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    Table 1

    Perioperative data for 1- and 2-level disc replacements

    Operative parameters1 Level (n = 12)2 Levels(n = 18)
    Estimated blood loss (mL)33.7 ± 17.466.8 ± 24.9
    Operative time (min)67.1 ± 21.4128.6 ± 31.8
    Hospital stay (d)1.1 ± 0.31.4 ± 0.8
    • NOTE. Values are mean ± standard deviation.

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    Table 2

    SF-36 Health Survey scores with preoperative versus postoperative comparisons

    Time pointSF-36 component scoreNo. of patientsMeanSDP value (preoperatively vs postoperatively)
    PreoperativelyPCS score3030.409.05
    MCS score3040.0612.56
    6 wkPCS score940.828.43.0138
    MCS score950.5010.14.126
    3 moPCS score3041.9010.34<.0001
    MCS score3047.2313.32.0145
    6 moPCS score2846.599.41<.0001
    MCS score2848.0514.22.0136
    12 moPCS score2848.759.45<.0001
    MCS score2849.1114.20.0118
    24 moPCS score2847.7411.04<.0001
    MCS score2846.3013.34.1364
    • View popup
    Table 3

    One- and two-level clinical outcomes

    1 Level2 Level
    PreoperativelyPostoperativelyPreoperativelyPostoperativelyP value
    No. of patients12121816
    NDI73.7 ± 13.131.7 ± 19.363.9 ± 13.713.4 ± 13.2.26
    VAS for neck pain8.0 ± 2.24.0 ± 3.27.5 ± 2.00.8 ± 1.1.03
    VAS for right arm pain7.0 ± 2.03.2 ± 2.95.4 ± 3.40.9 ± 1.5.97
    VAS for left arm pain7.2 ± 2.62.6 ± 2.95.6 ± 3.50.5 ± 1.1.81
    SF-36 PCS25.3 ± 9.740.6 ± 10.433.8 ± 753.1 ± 8.3.41
    SF-36 MCS41.3 ± 13.339.8 ± 14.639.2 ± 12.351.1 ± 10.3.09
    • NOTE. Values are mean ± standard deviation; P values represent the comparison of the 2 groups based on the change from baseline to 24-month follow-up.

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International Journal of Spine Surgery
Vol. 6
1 Jan 2012
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Cervical total disc replacement using a novel compressible prosthesis: Results from a prospective Food and Drug Administration–regulated feasibility study with 24-month follow-up
Carl Lauryssen, Domagoj Coric, Thomas Dimmig, David Musante, Donna D. Ohnmeiss, Harrison A. Stubbs
International Journal of Spine Surgery Jan 2012, 6 71-77; DOI: 10.1016/j.ijsp.2012.02.001

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Cervical total disc replacement using a novel compressible prosthesis: Results from a prospective Food and Drug Administration–regulated feasibility study with 24-month follow-up
Carl Lauryssen, Domagoj Coric, Thomas Dimmig, David Musante, Donna D. Ohnmeiss, Harrison A. Stubbs
International Journal of Spine Surgery Jan 2012, 6 71-77; DOI: 10.1016/j.ijsp.2012.02.001
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Keywords

  • cervical total disc replacement
  • cervical radiculopathy
  • M6-C artificial cervical disc
  • fusion

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