Clinical trial NCT05884593: Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
Official title: Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Deformity
Spinal Infection
Trauma
Neoplastic Processes
Degenerative Spinal Conditions
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Total deviation (mm) from the pre-planned screw entry point
timeFrame: study completion average 2years
Secondary outcomes:
measure: Accuracy assessment for degree of pedicle breach
timeFrame: 6 weeks post surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center Neurological Surgery
state: Ohio
Study officials:
References:
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citation: Wiesner L, Kothe R, Ruther W. Anatomic evaluation of two different techniques for the percutaneous insertion of pedicle screws in the lumbar spine. Spine (Phila Pa 1976). 1999 Aug 1;24(15):1599-603. doi: 10.1097/00007632-199908010-00015.
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