Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT05884593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2023-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: