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

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.

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.

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)