Multicenter Study on Safety and Performance of Ennovate4 Cervical Spine Stabilization System Including All Approved Uses for Spine Conditions

What this Trial Is About

Researchers are conducting a multicenter post-market clinical follow-up study to monitor the safety and performance of the Ennovate4 Cervical system. This observational study collects data from patients treated with the implant for various conditions such as spine fractures, degenerative disc disease, spinal instability, spinal tumors, and degenerative myelopathy. The study aims to provide detailed implant documentation valuable for current and future users of this internal fixation system. The Ennovate4 Cervical Spinal System is designed for posterior stabilization of the cervical and upper-thoracic spine, including monosegmental and multisegmental stabilization of the occipitocervical junction and cervical spine. Patients who were treated with this device according to its instructions for use are included in this study. The study gathers information prospectively on all patients receiving this implant under routine medical care. Participants will be followed up through clinical and radiological evaluations before surgery, then at 3 months and 12 months after surgery. Researchers will measure changes in pain, quality of life, neurological status, disability, and bone fusion at these time points. Side effects will be recorded throughout the 12-month follow-up period. The total duration of participant involvement spans from surgery to one year postoperatively, ensuring comprehensive safety and performance monitoring.

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical