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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Pedicle screw instrumentation using Mazor X robotic system


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>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<br>* Pedicle screw instrumentation using Mazor X robotic system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total deviation (mm) from the pre-planned screw entry point | 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 | The secondary outcome will include traditional accuracy assessment for degree of pedicle breach utilizing the Gertzbein and Robbins classification system. | 6 weeks post surgery |