Degenerative Spinal Conditions, Neoplastic Processes, Spinal Deformity, Spinal Infection, Trauma
Conditions
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.
Interventions
DEVICEPedicle screw instrumentation using Mazor X robotic system
Pedicle screw instrumentation using Mazor X robotic system
Sponsors
Medtronic
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total deviation (mm) from the pre-planned screw entry point | study completion average 2years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy assessment for degree of pedicle breach | 6 weeks post surgery | The secondary outcome will include traditional accuracy assessment for degree of pedicle breach utilizing the Gertzbein and Robbins classification system. |
Countries
United States
Outcome results
None listed