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Terminated
NCT05884593
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
Conditions: Spinal Deformity, Spinal Infection, Trauma, Neoplastic Processes, Degenerative Spinal Conditions
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Ohio State University
Location: The Ohio State University Wexner Medical Center Neurological Surgery Columbus Ohio
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT05884593). StuddyBuddy aggregates publicly available trial information.