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

August 7, 2025 updated by: Andrew Grossbach, Ohio State University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43219
        • The Ohio State University Wexner Medical Center Neurological Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 18 years old
  • Degenerative conditions, spinal deformity, spinal infection, traumatic injuries, or neoplastic processes between T2-S1 necessitating placement of pedicle screw instrumentation.
  • Surgery performed at The Ohio State University Wexner Medical Center (OSUWMC) via one of the study investigators

Exclusion Criteria:

  • Current or previous spinal tumor
  • Severe co-morbidities (e.g., heart, respiratory, or renal disease)
  • Concurrent involvement in another investigational drug or device study that could confound study data
  • Subjects who are pregnant
  • Prisoner
  • Subjects who do not speak English Relative Exclusion Criteria
  • Prior pedicle screw instrumentation at that level (i.e. prior L4-5 instrumentation, now undergoing an L4-S1 fusion, only new S1 screw accuracy would be evaluated in this patient)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system.
Device: Pedicle screw instrumentation using Mazor X robotic system
Pedicle screw instrumentation using Mazor X robotic system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total deviation (mm) from the pre-planned screw entry point
Time Frame: study completion average 2years
Total deviation (mm) from the pre-planned screw entry point includes: deviation in angle of insertion in the axial plane (degrees), and deviation in angle of insertion in the sagittal plane (degrees) from an O-arm spin after screw placement.
study completion average 2years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy assessment for degree of pedicle breach
Time Frame: 6 weeks post surgery
The secondary outcome will include traditional accuracy assessment for degree of pedicle breach utilizing the Gertzbein and Robbins classification system.
6 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020H0434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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