NCT02212899

Prospective, Observational Registry of Renaissance-guided Spine Surgeries

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Mazor Robotics · Industry
• Sex: All
• Age: 6 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.

Detailed description

The key objective of this observational registry is to prospectively collect data to facilitate the quantification of potential short- and long-term benefits of Renaissance-guided spine surgery. It establishes a common framework for collaboration between surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or open surgical approaches. The main endpoints that will be collected are surgical endpoints (e.g. complication rates), patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal alignment, mainly in reconstructive surgeries for spinal deformities) and technical parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).

Conditions

• Degenerative Spine Disease
• Spinal Deformity

Timeline

• Start date: 2015-02-18
• Primary completion: 2016-12-30
• Completion: 2016-12-30
• First posted: 2014-08-08
• Last updated: 2020-10-05

Locations

4 sites across 1 country: United States