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OpenTrials
Active, Not Recruiting

NCT Number: NCT05884593

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, 43219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pedicle screw instrumentation using Mazor X robotic system

Device

Pedicle screw instrumentation using Mazor X robotic system

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jun 1, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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