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Research ArticleArticle
Open Access

ISASS Policy Statement – Cervical Artificial Disc

Domagoj Coric
International Journal of Spine Surgery January 2014, 8 6; DOI: https://doi.org/10.14444/1006
Domagoj Coric
Department of Neurosurgery, Carolinas Medical Center, Charlotte, NC USA
MD
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    Table 1

    FDA-approved cTDR devices with number of patients enrolled in pivotal IDE study.

    cTDR Device # of Patients
    Prestige ST541
    Prodisc-C209
    Bryan Disc463
    Secure-C380
    PCM342
    Mobi-C 1-level260
    Mobi-C 2-level339
    TOTAL 2534
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    Table 2

    Composite overall success rates from pivotal IDE study, cTDR versus ACDF.

    IDE study CTDR ACDF
    Prestige ST79%68%
    Prodisc-C72%68%
    Bryan Disc83%73%
    Secure-C84%73%
    PCM75%65%
    Mobi-C 1-level74%65%
    Mobi-C 2-level70%37%
    Kineflex/C85%71%
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    Table 3

    Range of motion (ROM) for cTDR devices from pivotal IDE study.

    IDE study Mean ROM (degrees)
    Prestige ST7.7
    Prodisc-C8.4
    Bryan Disc6.5
    Secure-C9.7
    PCM5.7
    Mobi-C 1-level10.8
    Mobi-C 2-level10.1, 8.3
    Kineflex/C9.8
    • View popup
    Table 4

    Indications for cervical total disc replacement (cTDR).

    Cervical arthroplasty is indicated in patients meeting the following criteria:
    • Skeletally mature

    • Clinically symptomatic cervical radiculopathy and/or myelopathy due to neural compression C3-C7 at one-level or two contiguous levels

    • Failed at least 6 weeks of nonsurgical treatment or shows signs of progressively clinical deterioration

    Clinically symptomatic pertains to one of the following:
    • Intractable radiculopathy (arm pain and/or a neurological deficit) with or without associated neck pain

    • Myelopathy (due to abnormality localized to the level of the disc space)

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International Journal of Spine Surgery
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1 Jan 2014
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ISASS Policy Statement – Cervical Artificial Disc
Domagoj Coric
International Journal of Spine Surgery Jan 2014, 8 6; DOI: 10.14444/1006

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ISASS Policy Statement – Cervical Artificial Disc
Domagoj Coric
International Journal of Spine Surgery Jan 2014, 8 6; DOI: 10.14444/1006
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