Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

This study will comprehensively evaluate the outcomes and endpoints of these two different FDA-approved artificial disc implants used to treat cervical spondylotic myelopathy and/or radiculopathy today: Biomet Zimmer Mobi-C and Nuvasive Simplify. Both implants are structurally different with the Nuvasive Simplify implementing a three-piece design with two endplates and a semi-constrained mobile core while the Biomet Zimmer Mobi-C implements an unconstrained three piece design. Subjects will be age-matched and randomly assigned to either implant with informed consent. All subjects will undergo a variety of assessments that evaluate neck disability, quality of life, pain, physiological outcome (radiographic assessments), and neck range-of motion before and after their procedure. One baseline testing will be conducted along with three post-operation visits (three months, six months, and one year) in accordance to standard follow-up procedure. Thus, the duration of participation in the study will be approximately one and a half years.

Inclusion Criteria:Patient is skeletally mature and between 18 to 60 years of ageExperiences cervical spondylotic myelopathy and/or radiculopathy typically caused by disc herniation or degenerative disc disease at a single level between C3 to C7Is unresponsive to at least six weeks of non-surgical conservative careHas the intention of undergoing cervical arthroplasty for their chief complaintSigned informed consent formExclusion Criteria:Patient has had prior cervical spine surgeryHas more than two diseased levels requiring surgeryHas a known allergy to a metal alloy or polyethyleneIs morbidly obeseHas active local or system infectionHas any circumstances or conditions such that their ability to provide informed consent comply with follow-up requirements, or provide self-assessments is compromised (eg: psychiatric disorders, chronic alcohol or substance abuse, etc.)