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

Abstract

OBJECTIVE: We sought to determine the safety and effectiveness of the Flexible Cervical Implant in 1- or 2-level cervical segments. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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