Study Comparing Two FDA-Approved Artificial Disc Implants for Cervical Spine Surgery Evaluating the Biomet Zimmer Mobi-C and Nuvasive Simplify Devices in Adults with Neck Disc Conditions

What this Trial Is About

Researchers are evaluating two FDA-approved artificial disc implants used in cervical disc arthroplasty to treat cervical spondylotic myelopathy andor radiculopathy caused by disc herniation or degenerative disc disease. The study compares the Biomet Zimmer Mobi-C, which has an unconstrained three-piece design, and the Nuvasive Simplify, which features a semi-constrained three-piece design with two endplates and a mobile core. This comparison aims to assess differences in patient outcomes and help inform personalized treatment decisions. Participants will be randomly assigned to receive either the Nuvasive Simplify or the Biomet Zimmer Mobi-C implant during cervical arthroplasty surgery. Both implants are inserted to replace a damaged disc in a single cervical spine level between C3 and C7. The study includes one baseline assessment before surgery and follow-up visits at three months, six months, and one year after the procedure, following standard care protocols. During the study, participants will undergo several evaluations including neck disability questionnaires, neurological exams such as gait and foraminal compression tests, and various radiographic assessments to measure disc height, angle, range of motion, translational motion, device subsidence, and intervertebral angles. The primary outcome is cervical range of motion measured at multiple time points. The total participation duration is approximately one and a half years, allowing for comprehensive monitoring of outcomes and safety.

Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty