Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System (NCT05884593) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
United States50 participantsStarted 2021-03-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Total deviation (mm) from the pre-planned screw entry point