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Research ArticleCervical Spine

Anterior Cervical Discectomy and Fusion With a No-Profile Integrated Fixation Allograft Device: An In Vitro Biomechanical Analysis and Clinical Case Series

Nima Salari, Gina Konz, Chris Ferry, Anup Gandhi, Andy Freeman, Richard Davis and Chris Yeung
International Journal of Spine Surgery April 2022, 16 (2) 247-255; DOI: https://doi.org/10.14444/8224
Nima Salari
1 Orthopaedic Spine Surgeon, Desert Institute for Spine Care, Phoenix, AZ, USA
MD
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Gina Konz
2 Lake Region Medical, Brooklyn Park, MN, USA
PhD
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Chris Ferry
3 Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA
MD
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Anup Gandhi
4 Pre-Clinical Research & Testing, Zimmer Biomet Spine, Westminster, CO, USA
PhD
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Andy Freeman
5 Fortus Medical, Minneapolis, MN, USA
MS
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Richard Davis
6 Orthopaedic Spine Surgeon, Healthpartners Specialty Center, Saint Paul, MN, USA
MD
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Chris Yeung
7 Orthopaedic Spine Surgeon, Desert Institute for Spine Care, Phoenix, AZ, USA
MD
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  • Figure 1
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    Figure 1

    No-profile integrated fixation anterior cervical discectomy and fusion device demonstrating pronounced implant body height relative to plate height (left) and independently connected (nonaffixed) implant body (right).

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    Figure 2

    Fluoroscopic images of instrumented test specimens. (A) No-profile anterior cervical discectomy and fusion (npACDF) device with connected polyetheretherketone (PEEK) implant body. (B) npACDF device with connected allograft implant body. (C) npACDF device with nonconnected allograft implant body. (D) Standard anterior ACDF plate and PEEK interbody cage.

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    Figure 3

    Mean range-of-motion (ROM), relative to intact conditions, when loaded in flexion/extension under a pure moment of ±2.5 Nm. Bars represent the mean, and error bars are SD. Symbols denote significant differences (P < 0.05) between groups according to an ordinary 1-way analysis of variance with Bonferonni’s correction for multiple comparisons; PEEK, polyetheretherketone.

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    Figure 4

    Mean range-of-motion, relative to intact conditions, when loaded in lateral bending under a pure moment of ±2.5 Nm. Bars represent the mean, and error bars are SD. Symbols denote significant differences (P < 0.05) between groups according to an ordinary 1-way analysis of variance with Bonferonni’s correction for multiple comparisons; PEEK, polyetheretherketone.

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    Figure 5

    Mean range-of-motion, relative to intact conditions, when loaded in axial rotation under a pure moment of ±2.5 Nm. Bars represent the mean, and error bars are SD. Symbols denote significant differences (P < 0.05) between groups according to an ordinary 1-way analysis of variance with Bonferonni’s correction for multiple comparisons; PEEK, polyetheretherketone.

Tables

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    Table 1

    Raw range-of-motion (ROM) outcomes (degrees).

    NPP + cPEEKNPP + cAllograftNPP + ncAllograftTP + Allograft Cage
     Intact ROMConstruct ROMIntact ROMConstruct ROMIntact ROMConstruct ROMIntact ROMConstruct ROM
     MeanSDMeanSDMeanSDMeanSDMeanSDMeanSDMeanSDMeanSD
    FE10.71.96.83.312.22.67.31.711.72.97.13.212.03.93.22.9
    LB8.93.05.74.79.32.24.82.19.42.45.23.99.32.83.73.1
    AR7.03.04.53.37.71.54.81.87.92.54.63.09.05.33.64.4
    • AR, axial rotation; FE, flexion/extension; LB, lateral bending; NPP + cAllograft, no-profile ACDF device with connected allograft implant body; NPP + cPEEK, no-profile ACDF device with connected PEEK implant body; NPP + ncAllograft, no-profile ACDF device with nonconnected allograft implant body; TP + Allograft Cage, standard anterior ACDF plate and PEEK interbody cage.

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    Table 2

    Normalized (to intact) range-of-motion (ROM) outcomes.

    NPP + cPEEKNPP + cAllograftNPP + ncAllograftTP + Allograft Cage
     MeanSDMeanSDMeanSDMeanSD
    FE61%22%62%20%64%29%25%18%
    LB55%32%52%18%57%38%36%28%
    AR56%30%63%21%65%41%37%27%
    • AR, axial rotation; FE, flexion/extension; LB, lateral bending; NPP + cAllograft, no-profile ACDF device with connected allograft implant body; NPP + cPEEK, no-profile ACDF device with connected PEEK implant body; NPP + ncAllograft, no-profile ACDF device with nonconnected allograft implant body; TP + Allograft Cage, standard anterior ACDF plate and PEEK interbody cage.

    • View popup
    Table 3

    Patient demographics.

    CaseAge, ySexBMILevelPreoperative VAS Score12-mo VAS ScorePreoperative NDI Score12-mo NDI ScoreInterbody FusionSubsidence
    148M26.6C6/78250%4%YesNo
    273M30.4C3/45160%26%YesNo
    369F26.1C5/66234%16%YesNo
    458M28.5C7/T15052%0%YesNo
    564M29.8C5/65240%12%YesNo
    648F25.9C5/66022%4%YesNo
    758M23.3C5/67514%16%YesNo
    852F26.6C5/67040%8%YesYes
    948F20.4C5/65034%0%YesNo
    1052F33.1C6/78032%0%YesNo
    • BMI, body mass index; NDI, Neck Disability Index; VAS, visual analog scale.

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International Journal of Spine Surgery
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1 Apr 2022
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Anterior Cervical Discectomy and Fusion With a No-Profile Integrated Fixation Allograft Device: An In Vitro Biomechanical Analysis and Clinical Case Series
Nima Salari, Gina Konz, Chris Ferry, Anup Gandhi, Andy Freeman, Richard Davis, Chris Yeung
International Journal of Spine Surgery Apr 2022, 16 (2) 247-255; DOI: 10.14444/8224

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Anterior Cervical Discectomy and Fusion With a No-Profile Integrated Fixation Allograft Device: An In Vitro Biomechanical Analysis and Clinical Case Series
Nima Salari, Gina Konz, Chris Ferry, Anup Gandhi, Andy Freeman, Richard Davis, Chris Yeung
International Journal of Spine Surgery Apr 2022, 16 (2) 247-255; DOI: 10.14444/8224
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Keywords

  • cervical
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  • no-profile
  • zero-Profile
  • allograft
  • Biomechanics

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