Observational, Multicenter Study of the Efficacy and Safety of Cervical Disk Arthroplasty With Mobi-C in the Treatment of Cervical Degenerative Disk Disease. Results at 10 years Follow-Up

Abstract

Background. Cervical disk arthroplasty replacement (CDA) was developed to avoid specific disadvantages of cervical fusion. The purpose of this paper is to provide 10-year follow-up results of an ongoing prospective study after CDA. Methods. Three hundred eighty-four patients treated using the Mobi-C (ZimVie, Troyes, France) were included in a prospective multicenter study. Routine clinical and radiologic examinations were reported preoperatively and postoperatively with up to 10-year follow-up. Complications and revision surgeries were also documented. Results. At 10 years showed significant improvement in all clinical outcomes [Neck Disability Index, visual analog scale (VAS) for arm and neck pain, physical component summary of SF36, and mental component summary of SF36). Motion at the index level increased significantly over baseline (mean range of motion=7.6 vs. 8 degrees at five years and 6.0 degrees preoperatively; P<0.001) and 71.3% of the implanted segments remained mobile (range of motion>3 degrees). Adjacent disks were also mobile at 10 years with the same mobility as preoperatively. At 10 years, 20.9% of the implanted segments demonstrated no heterotopic ossification. Thirty-four patients (8.9%) experienced 41 adverse events, with or without reoperation during the first five years. We found only two additional surgeries after five years. We observed an increased percentage of working patients and a decrease in medication consumption. Regarding the overall outcome, 94% of patients were satisfied. Conclusions. Our 10-year results showed significant improvement in all clinical outcomes, with low rates of revision or failure. This experience in patients with long-term follow-up after CDA endorses durable, favorable outcomes in properly selected patients.