Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate4 Cervical - a Prospective Study on Total Indications

What this Trial Is About

This research aims to monitor the safety and performance of the Ennovate4 Cervical system, a device used for spinal stabilization in patients with various conditions such as spine fractures, degenerative disc disease, spinal instability, spinal tumors, and degenerative myelopathy. The study is a post-market clinical follow-up conducted across multiple centers to collect detailed implant data relevant to current and future users. It focuses on evaluating safety and efficacy for trauma and degenerative disorders involving the cervical and upper thoracic spine. The intervention involves the Ennovate4 Cervical Spinal System, which provides posterior stabilization for the cervical and upper thoracic spine. It is used for both single-segment and multi-segment stabilization of the occipitocervical junction and spine. All patients treated with this system according to the instructions for use are included in the study. The study collects data prospectively from these patients without additional treatment groups or placebo comparison. Participants are followed with assessments before surgery, and at three and twelve months after surgery. Researchers will evaluate changes in pain, quality of life, neurological status, and disability over time. Bone fusion is assessed at the final one-year follow-up. The study also tracks any side effects throughout the follow-up period. Participation involves clinical and radiological documentation, with total involvement lasting at least twelve months after surgery.

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