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European Spine Journal

, Volume 25, Issue 7, pp 2263–2270 | Cite as

A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF)

  • Thomas P. Loumeau
  • Bruce V. Darden
  • Thomas J. Kesman
  • Susan M. Odum
  • Bryce A. Van Doren
  • Eric B. Laxer
  • Daniel B. Murrey
Original Article

Abstract

Purpose

The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7.

Methods

We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed.

Results

Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group.

Conclusions

The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.

Keywords

Clinical trial Symptomatic cervical disc disease Total disc arthroplasty ProDisc-C Anterior cervical discectomy and fusion Outcomes 

Notes

Acknowledgments

This study is part of a multicenter US Food and Drug Administration investigational device exemption study funded by Synthes Spine, West Chester, PA, USA.

Compliance with ethical standards

Conflict of interest

The authors wish to acknowledge the following potential conflicts of interest: Paid consultant: 4Web, Spineguard, Stryker; Unpaid consultant: BioMedFlex, OrthoMedFlex; Paid speaker or presenter: Stryker, Synthes; IP royalties: Stryker; Research support: DePuy: A Johnson & Johnson Company, Synthes; Stock or stock options: BioMedFlex, 4Web, Amedica, OrthoMedFlex; Board member: Cervical Spine Research Society, Lumbar Spine Research Society, American Association of Hip & Knee Surgeons; Editorial board: Journal of Arthroplasty, Journal of Spinal Disorders & Techniques, Journal of Spinal Cord Medicine, Journal of the American Association of Orthopedic Surgeons.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Thomas P. Loumeau
    • 1
  • Bruce V. Darden
    • 1
  • Thomas J. Kesman
    • 1
  • Susan M. Odum
    • 2
  • Bryce A. Van Doren
    • 2
  • Eric B. Laxer
    • 1
  • Daniel B. Murrey
    • 3
  1. 1.OrthoCarolina Spine CenterCharlotteUSA
  2. 2.OrthoCarolina Research InstituteCharlotteUSA
  3. 3.OrthoCarolina, PACharlotteUSA

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