Study to Evaluate Safety and Effectiveness of CEM-Cage and CEM-Plate Devices for Two-Level Anterior Cervical Spine Surgery in Adults

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the CEM-Cage combined with the CEM-Plate in patients undergoing a two-level anterior cervical discectomy and fusion ACDF. It is a first-in-human, prospective, multi-center, non-randomized, single-arm study involving fifty patients with cervical spine conditions such as radiculopathy or myelopathy. The study is designed to provide important information about the devices performance in treating cervical degenerative disc disease. Participants will undergo a two-level ACDF surgery using the CEM-Plate Anterior Cervical Plating System and the CEM-Cage Cervical Interbody System. After surgery, patients will have follow-up visits at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. These visits include assessments such as quality of life surveys and imaging tests like lateral cervical x-rays to check the device placement and spinal fusion progress. Throughout the study, researchers will monitor for fusion success and overall outcomes, including the absence of serious adverse events or need for additional surgeries at the treated levels. Safety and device-related complications will be tracked for up to 24 months. Participants quality of life and spine function will be regularly evaluated, helping to understand the long-term effects of the device.

CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study