• Thomas P Loumeau, Bruce V Darden, Thomas J Kesman, Susan M Odum, Bryce A Van Doren, Eric B Laxer, and Daniel B Murrey.
• OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA.
• Eur Spine J. 2016 Jul 1; 25 (7): 2263-70.

PurposeThe 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.MethodsWe 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.ResultsTwenty-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.ConclusionsThe 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.

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