A Post-Market Study of Medtronic Cranial and Spinal Devices for Treating Spinal Conditions with Follow-Up to 24 Months

What this Trial Is About

Researchers are evaluating the performance and safety of Medtronic devices used for cranial and spinal conditions in this post-market clinical study. The study focuses on patients undergoing treatment with these devices for conditions such as spinal deformity, degenerative disorders, fusion failure, trauma, and tumors. The goal is to collect real-world data on how these devices work in routine clinical care. Participants receive Medtronic Cranial and Spinal Technology devices, which include powered systems, instruments, imaging devices, advanced energy devices, robotics, navigation, rods, screws, interbodies, biologics, spinal tethers, and other spinal hardware. The study follows patients from before their surgery through 24 months after the procedure to monitor device safety and performance across various device categories. During the study, participants undergo assessments from the pre-operative baseline up to 24 months post-surgery. Researchers measure surgical success shortly after surgery, fusion success at 12 months, device performance over 24 months, pain resolution, stabilization, and deformity correction at specified time points. Safety is monitored by tracking device-related adverse events. Participants are expected to complete all required follow-up visits and assessments according to the study schedule.

The Ailliance Post-Market Clinical Study