Study Comparing Safety and Benefits of Minimally Invasive Versus Open Surgery Using the Ennovate Cervical Spinal System for Pedicle Screw Placement

What this Trial Is About

Researchers are evaluating the safety and patient benefits of placing pedicle screws in the cervical spine using a new minimally invasive surgical approach compared to the standard open surgery. This study focuses on patients requiring stabilization of the cervical and upper thoracic spine due to conditions like fractures, degenerative instability, post-trauma instability, tumors, or degenerative cervical myelopathy. The goal is to collect clinical data on how these two surgical techniques compare in terms of safety and effectiveness. Participants will receive the EnnovateAE Cervical Spinal System implanted either through the innovative minimally invasive method or the conventional open surgical technique. Both approaches target posterior stabilization of the vertebrae between C2 and Th3. Patients will be randomly assigned to one of the two methods, and the study involves a single-masked design to compare outcomes between the groups. During the study, participants will undergo several assessments including pain measurement using the Visual Analogue Scale VAS shortly after surgery and at multiple follow-up points up to two years. Other evaluations include screw placement accuracy, neck disability index, and quality of life questionnaires over several months to years postoperatively. Adverse events will be tracked throughout the study period. Overall participation may last up to two years, with regular follow-up visits to monitor recovery and outcomes.

Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement