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Research ArticleCervical Spine

Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial

ALEXANDER VACCARO, WILLIAM BEUTLER, WALTER PEPPELMAN, JOSEPH MARZLUFF, ANDREW MUGGLIN, PREM S. RAMAKRISHNAN, JACQUELINE MYER and KELLY J. BAKER
International Journal of Spine Surgery June 2018, 12 (3) 377-387; DOI: https://doi.org/10.14444/5044
ALEXANDER VACCARO
1Rothman Institute, Philadelphia, Pennsylvania
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WILLIAM BEUTLER
2Pennsylvania Spine Institute, Harrisburg, Pennsylvania
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WALTER PEPPELMAN
2Pennsylvania Spine Institute, Harrisburg, Pennsylvania
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JOSEPH MARZLUFF
3Trident Regional Medical Center, Charleston, South Carolina
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ANDREW MUGGLIN
4Paradigm Biostatistics LLC, Anoka, Minnesota
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PREM S. RAMAKRISHNAN
5Globus Medical, Audubon, Pennsylvania
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JACQUELINE MYER
5Globus Medical, Audubon, Pennsylvania
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KELLY J. BAKER
5Globus Medical, Audubon, Pennsylvania
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  • Figure 1
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    Figure 1

    Mean neck disability index (NDI) scores (+SD) for the randomized SECURE-C and anterior cervical discectomy and fusion (ACDF) groups through 84 months postoperative.

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    Figure 2

    Mean visual analog scale (VAS) neck pain scores (+SD) for the randomized SECURE-C and anterior cervical discectomy and fusion (ACDF) groups through 84 months postoperative.

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    Figure 3

    Mean visual analog scale (VAS) left arm pain scores (+SD) for the randomized SECURE-C and anterior cervical discectomy and fusion (ACDF) groups through 84 months postoperative.

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    Figure 4

    Mean visual analog scale (VAS) right arm pain scores (+SD) for the randomized SECURE-C and anterior cervical discectomy and fusion (ACDF) groups through 84 months postoperative.

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    Figure 5

    Mean 36-Item Short Form Health Survey (Mental Composite Score [MCS] and Physical Composite Score [PCS]) scores for the randomized SECURE-C and anterior cervical discectomy and fusion (ACDF) groups through 84 months postoperative.

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    Figure 6

    Cumulative secondary surgeries at treated level by at least 84 months postoperative. Abbreviation: ACDF, anterior cervical discectomy and fusion.

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    Figure 7

    Postoperative radiographs obtained at 84 months showing SECURE-C device in (a) flexion and (b) extension.

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    Figure 8

    Mean flexion-extension range of motion (ROM) at the operated level through 84 months postoperative. Abbreviation: ACDF, anterior cervical discectomy and fusion.

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    Figure 9

    Mean translation range of motion (ROM) at the operated level through 84 months postoperative. Abbreviation: ACDF, anterior cervical discectomy and fusion.

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    Figure 10

    Cumulative adjacent level surgeries through 84 months postoperative. Abbreviation: ACDF, anterior cervical discectomy and fusion.

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International Journal of Spine Surgery
Vol. 12, Issue 3
1 Jun 2018
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Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial
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Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial
ALEXANDER VACCARO, WILLIAM BEUTLER, WALTER PEPPELMAN, JOSEPH MARZLUFF, ANDREW MUGGLIN, PREM S. RAMAKRISHNAN, JACQUELINE MYER, KELLY J. BAKER
International Journal of Spine Surgery Jun 2018, 12 (3) 377-387; DOI: 10.14444/5044

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Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial
ALEXANDER VACCARO, WILLIAM BEUTLER, WALTER PEPPELMAN, JOSEPH MARZLUFF, ANDREW MUGGLIN, PREM S. RAMAKRISHNAN, JACQUELINE MYER, KELLY J. BAKER
International Journal of Spine Surgery Jun 2018, 12 (3) 377-387; DOI: 10.14444/5044
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Keywords

  • cervical
  • total disc arthroplasty
  • motion preservation
  • total disc replacement
  • anterior cervical discectomy and fusion
  • follow-up
  • 84 months
  • noninferiority
  • superiority
  • selectively constrained
  • adverse events
  • clinical trial
  • symptomatic
  • cervical disc disease
  • Bayesian

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