International Observational Study on the Safety and Performance of the MOVE-C Cervical Disc Prosthesis Following Mono- and Bisegmental Cervical Disc Replacement

What this Trial Is About

Researchers are conducting an international, prospective, multicenter, non-randomized observational study to confirm the safety and performance of the cervical disc prosthesis MOVE4-C. The study also aims to understand how patients quality of life changes after implantation and to assess the range of motion, which is important for implants that preserve movement. This research focuses on individuals with discopathy, herniated cervical discs, spinal stenoses, or radiculopathy. The study involves a single group of 170 patients who will receive a mono- or bisegmental implantation of the MOVE4-C cervical prosthesis. This device-based intervention is observed without randomization or a comparison group. The research collects clinical and radiological data to evaluate the devices performance over time. There are no placebo or blinded treatments involved. Participants will be followed up from baseline through 24 months after implantation. Researchers will assess improvements in neck disability, arm and neck pain using the Neck Disability Index and Visual Analogue Scales, as well as other health and function measures like the Core Outcome Measure Index, SF-36, EuroQoL, and Japanese Orthopedic Association Score. Range of motion and any adverse events related to the device will be monitored. The study includes clinical visits and evaluations to collect these outcomes and ensure safety throughout the follow-up period.

Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C