NCT05884593

Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess screw deviation from pre-planned trajectory using the Mazor X robotic system in patients undergoing posterior thoracolumbar arthrodesis procedures between T2-S1.

Detailed description

This trial will prospectively evaluate screw deviation from pre-planned trajectory using the standard of care Mazor X robotic system. Patients undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation at previously uninstrumented levels for degenerative conditions, spinal deformity, spinal infection, trauma, or neoplastic processes between T2-S1 will be asked to participate in this prospective cohort study. This single centered study will enroll up to 50 patients to achieve a total number of 250 screws for assessment. Subjects will be followed till discharge following surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for posterior thoracolumbar arthrodesis surgery.

Conditions

• Spinal Deformity
• Spinal Infection
• Trauma
• Neoplastic Processes
• Degenerative Spinal Conditions

Interventions

Type	Name	Description
DEVICE	Pedicle screw instrumentation using Mazor X robotic system	Pedicle screw instrumentation using Mazor X robotic system

Timeline

• Start date: 2021-03-05
• Primary completion: 2023-12-31
• Completion: 2025-12-30
• First posted: 2023-06-01
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study