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

Not Applicable

Active, not recruiting

• Conditions: Neoplastic Processes; Degenerative Spinal Conditions; Spinal Deformity; Spinal Infection; Trauma
• Interventions: Device: Pedicle screw instrumentation using Mazor X robotic system

• Registration Number: NCT05884593
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2021-03-05
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total deviation (mm) from the pre-planned screw entry point	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 Outcome Measures

Name	Time	Method
Accuracy assessment for degree of pedicle breach	6 weeks post surgery	The secondary outcome will include traditional accuracy assessment for degree of pedicle breach utilizing the Gertzbein and Robbins classification system.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center Neurological Surgery; 🇺🇸 Columbus, Ohio, United States