• Spine · Nov 2019

    Implant Design and the Anchoring Mechanism influence the Incidence of Heterotopic Ossification in cervical Total Disc Replacement at 2-year follow-up.

    • Christoph Mehren, Karin Wuertz-Kozak, Daniel Sauer, Wolfgang Hitzl, Tuna Pehlivanoglu, and Franziska Heider.
    • Schön Klinik München Harlaching, Spine Center, Munich, Germany.
    • Spine. 2019 Nov 1; 44 (21): 1471-1480.

    Study DesignA nonrandomized, prospective, and single-center clinical trial.ObjectiveThe aim of this study was to determine whether the prosthesis design, and especially changes in the primary anchoring mechanism between the keel-based ProDisc C and the spike-based ProDisc Vivo, affects the frequency of heterotopic ossification (HO) formation over time.Summary Of Background DataThe occurrence of motion-restricting HO as well as underlying risk factors has so far been a widely discussed, but not well understand phenomenon. The anchoring mechanism and the opening of the anterior cortex may be possible causes of this unwanted complication.MethodsForty consecutive patients treated with the ProDisc C and 42 consecutive patients treated with the ProDisc Vivo were compared with respect to radiological and clinical outcome, with 2 years of follow-up. Clinical outcome scores included the Neck Disability Index (NDI), Visual Analogue Scale (VAS), and arm and neck pain self-assessment questionnaires. Radiological outcomes included the segmental lordosis and range of motion (ROM) of the index-segment as well as the occurrence of HO.ResultsThe clinical outcome parameters improved in both groups significantly. [ProDisc C: VAS arm and neck pain from 6.3 and 6.2 preoperatively to 0.7 and 1.3; NDI from 23.0 to 3.7; ProDisc Vivo: VAS arm and neck pain from 6.3 and 4.9 to 1.4 and 1.6, NDI from 34.1 to 8.7; 2-year follow-up (FU)]. The ProDisc Vivo cohort demonstrated a significantly lower incidence of HO than the ProDisc C group at 1-year FU (P = 0.0005) and 2-year FU (P = 0.005). Specifically, high-grade HO occurred in 9% versus 31%.ConclusionThese findings demonstrate that prosthesis designs that allow primary anchoring without violation of the cortical surface help to reduce the incidence of severe ossification, possibly affecting the functionality and mobility of the artificial disc device over of time.Level Of Evidence3.

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