Clinical and Radiologic Outcomes of the SYMPHONY22 OCT System for Treating Upper Spine Instabilities in the Craniocervical Junction, Cervical, and Upper Thoracic Spine

What this Trial Is About

Researchers are evaluating the SYMPHONY22 OCT System, a CE-marked medical device used in surgery to stabilize the upper spine in patients with conditions like degenerative cervical issues, traumatic spinal fractures or dislocations, failed previous fusions, or tumors affecting the cervical or thoracic spine. This pilot study at a National Tertiary Referral Centre aims to compare outcomes using this device with historical cases treated by another system called the Mountaineer. Participants will undergo posterior spinal fusion surgery using the SYMPHONY22 OCT System, which includes internal fixation tools such as screws, rods, hooks, and connectors to support bone fusion and stability in the upper spine. The device is FDA approved and is used as an adjunct to fusion to treat both acute and chronic upper spinal instabilities. The study plans to follow each participant for two years after surgery. Throughout the study, participants will have regular assessments including X-rays or CT scans to evaluate spinal fusion and stability at 24 months. Patient-reported pain and function will also be monitored using tools like the Visual Analogue Scale, Short Form 12, and Neck Disability Index during follow-up. The study will track safety and clinical outcomes over the two-year period to understand the device's performance in real-world use.

SYMPHONY™ OCT System for Instabilities of the Upper Thoracic and Cervical Spine