Safety and Effectiveness of the Flexible Cervical Implant: Preliminary Short-Term Clinical Results.

Abstract

We sought to determine the safety and effectiveness of the Flexible Cervical Implant in 1- or 2-level cervical segments. Retrospective data collection was carried out on consecutive patients who underwent the implantation of the Flexible Cervical Implant in a local private health institution. Demographics, clinical pictures, magnetic resonance images, x-ray images, technical considerations, and postoperative clinical results were reviewed. Twelve patients were treated with 15 implants. The mean age was 57.5 years (range 28-81), and 6 patients were males. The most common level was C5/C6 (7 cases). Radicular pain was the main symptom in all patients. Short-term postoperative clinical outcomes showed improvement in the visual analog scale (VAS) and the Neck Disability Index (NDI). The median VAS score for radicular pain improved from 6 to 2 (P < 0.001), whereas the median NDI showed a significant improvement from 25 to 5 (P < 0.001). No implant-related complications were reported. The mean follow-up was 7.3 months. The newly developed Flexible Cervical Implant was safe and effective in terms of morbidity and improvement in clinical outcomes. This new cervical artificial disk is promising, and further long-term clinical and radiologic follow-up is needed to determine its benefits.