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

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

NCT ID: NCT05884593

Condition: Spinal Deformity
Spinal Infection
Trauma
Neoplastic Processes
Degenerative Spinal Conditions

Conditions: Official terms:
Neoplastic Processes

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Pedicle screw instrumentation using Mazor X robotic system
Description: Pedicle screw instrumentation using Mazor X robotic system
Arm group label: Arm 1

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.

Criteria for 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The Ohio State University Wexner Medical Center Neurological Surgery

Address:
City: Columbus
Zip: 43219
Country: United States

Start date: March 5, 2021

Completion date: June 30, 2024

Lead sponsor:
Agency: Ohio State University
Agency class: Other

Collaborator:
Agency: Medtronic
Agency class: Industry

Source: Ohio State University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05884593