• Tuna Pehlivanoglu, Karin Wuertz-Kozak, Franziska Heider, Daniel Sauer, Lorenz Wanke-Jellinek, Michael Mayer, and Christoph Mehren.
• Spine Center, Schoen Clinic Munich Harlaching, Academic Teaching Hospital and Spine Research Institute of the Paracelsus Medical University (PMU), Salzburg, Austria.
• Spine. 2019 Oct 15; 44 (20): 1403-1411.

Study DesignA nonrandomized, prospective, and single-center clinical trial.ObjectiveThe aim of this study was to investigate the clinical and radiographic efficacy of ProDisc Vivo cervical total disc replacement (cTDR) in patients with clinical and radiographic documented cervical spondylotic myelopathy (CSM), due to degenerative changes at the index level.Summary Of Background DataDecompression and fusion is still the gold standard in patients with cervical myelopathy. Very limited data are available regarding the application of cTDR in patients with clinical and radiological documented CSM in context of clinical and radiographic outcomes.MethodsClinical outcome scores included the Neck Disability Index (NDI), Visual Analogue Scale (VAS), arm and neck pain self-assessment questionnaires as well as the Nurick grade and the Japanese Orthopaedic Association (JOA) score. The radiological outcome included the range of motion (ROM), the segmental and global (C2-C7) lordosis, and the occurrence of heterotopic ossifications.ResultsEighteen consecutive patients (10 males, 8 females) with documented clinical and radiological signs of myelopathy were included in this investigation. The study population had a mean age of 52.4 years and a follow-up period of 20.3 months in average (range 3-48 months). The mean range ROM of the index level stayed consistent with 6.8° preoperatively and 7.2° (P = 0.578) at the last follow-up; the global lordosis in neutral position changed from 3.5° to 14.2° significantly (P = 0.005) in mean. The JOA score improved from 11.3 to 16.6 (P < 0.001) as well as the NDI 36.7 to 10.3 (P < 0.001) and the VAS score from 5.7/6.1 (arm/neck) to 1.3/2.0 (P < 0.001/P < 0.001). The mean Nurick grade was 1.33 preoperatively and dropped down in all cases to Nurick grade of 0 (P < 0.001).ConclusioncTDR (with ProDisc Vivio) in patients with CSM yielded good clinical and radiographic outcomes and found as a reliable, safe, and motion-preserving surgical treatment option, although its indication is very limited due to numerous exclusion criteria.Level Of Evidence4.

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