Observational Study on Safety and Effectiveness of Synergy Cervical Disc System for Cervical Disc Degeneration

What this Trial Is About

Researchers are collecting real world data to examine the safety and performance of the Synergy Cervical Disc System in adults with degenerative cervical disc disease. This observational study includes both prospective and retrospective parts, enrolling patients who have had or will have the Synergy Disc implanted. The study aims to provide information about the devices effects in typical clinical use settings. Participants either have already received the Synergy Cervical Disc implant and are included in the retrospective arm, or they have decided to undergo implantation and join the prospective arm. The study includes patients with nerve root or spinal cord compression due to disc herniation or osteophyte formation, who have symptoms like arm or neck pain and have not improved after at least 6 weeks of conservative treatment. During the study, participants will be monitored through regular assessments including the Neck Disability Index and tracking of any device-related adverse events up to 12 months after implantation. Additional evaluations such as pain levels, patient satisfaction, neurological function, and specific clinical criteria will be collected before surgery and at multiple postoperative time points, including 6 weeks, 3 months, 6 months, 12 months, and annually. The total follow-up period can extend up to several years, providing a comprehensive view of patient outcomes and device performance.

Real World Data Collection on the Synergy Cervical Disc