Research ArticleLumbar Spine

Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results

Kris Radcliff, Jack Zigler, Ernest Braxton, Glen Buttermann, Dom Coric, Peter Derman, Rolando Garcia, Anton Jorgensen, Nicole C. Ferko, Aaron Situ and James Yue
International Journal of Spine Surgery August 2021, 15 (4) 612-632; DOI: https://doi.org/10.14444/8083

Article Figures & Data

Figures

  • Figure 1
    Figure 1

    CONSORT flow diagram, activL versus ProDisc-L.

  • Figure 2
    Figure 2

    Radiographs of total disc replacement implants. (A) Anteroposterior view of activL, (B) lateral view of activL, (C) anteroposterior view of ProDisc-L, and (D) lateral view of ProDisc-L.

  • Figure 3
    Figure 3

    Oswestry Disability Index (ODI) through 7 years after treatment for activL versus ProDisc-L artificial discs. Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.

  • Figure 4
    Figure 4

    Visual analog scale (VAS) back and leg score through 7 years after treatment for activL versus ProDisc-L artificial discs. Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.

  • Figure 5
    Figure 5

    Thirty-six-item short form survey (SF-36), Mental Component Summary (MCS), and Physical Component Summary (PCS) data through 7 years after treatment for activL versus ProDisc-L artificial discs. Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.

  • Figure 6
    Figure 6

    Time to return to work through 7 years for activL versus ProDisc-L artificial discs. Kaplan-Meier estimate is 82% with activL and 74% with ProDisc-L. Log-rank P value = .34.

  • Figure 7
    Figure 7

    Freedom from serious adverse events through 7 years for activL versus ProDisc-L artificial discs. Kaplan-Meier estimate is 61.5% with activL and 43.1% with ProDisc-L. Log-rank P value = .011.

  • Figure 8
    Figure 8

    Opioid usage through 7 years after treatment for activL versus ProDisc-L artificial discs. At each follow-up time point postoperation, a significantly lower proportion of patients with activL and ProDisc-L total disc replacement (TDR) devices used opioids than at baseline (P < .01 at each time point). Multiple imputation was used for missing patient data.

  • Figure 9
    Figure 9

    Percentage of patients who achieved clinically significant improvement (CSI) at 7 years, stratified by their CSI status from predictor analysis for activL versus ProDisc-L artificial discs. Complete case analysis conducted (no imputations).

  • Figure A1
    Figure A1

    Oswestry Disability Index (ODI) through 7 years after treatment for activL versus control (ProDisc-L + Charité). Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.

  • Figure A2
    Figure A2

    Visual analog scale (VAS) back and leg score through 7 years after treatment for activL versus control (ProDisc-L + Charité). Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.

  • Figure A3
    Figure A3

    Thirty-six-item short form survey (SF-36), mental component summary (MCS), and physical component summary (PCS) through 7 years after treatment for activL versus control (ProDisc-L + Charité). Multiple imputation was used for missing patient data. Values are presented as mean ± 95% confidence interval.

  • Figure A4
    Figure A4

    Time to return to work through 7 years for activL versus control (ProDisc-L + Charité). Kaplan-Meier estimate is 82% with activL and 74% with control. Log-rank P value = .069.

  • Figure A5
    Figure A5

    Freedom from serious adverse events through 7 years for activL versus control (ProDisc-L + Charité). Kaplan-Meier estimate is 61.5% with activL and 44.3% with control. Log-rank P value = .0024.

  • Figure A6
    Figure A6

    CONSORT 2010 flow diagram.

Tables

  • Table 1
  • Table 2
  • Table 3
  • Table 4
  • Table 5
  • Table A1
  • Table A2
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Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results
Kris Radcliff, Jack Zigler, Ernest Braxton, Glen Buttermann, Dom Coric, Peter Derman, Rolando Garcia, Anton Jorgensen, Nicole C. Ferko, Aaron Situ, James Yue
International Journal of Spine Surgery Aug 2021, 15 (4) 612-632; DOI: 10.14444/8083
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