NCT02057744

MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries

Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Mazor Robotics · Industry
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.

Conditions

• Degenerative Spine Disease
• Spondylolisthesis
• Spondylosis

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2014-02-07
• Last updated: 2019-08-20

Locations

9 sites across 1 country: United States