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

The Ohio State University

Status: Active, not recruiting

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

Treatments: Device: Pedicle screw instrumentation using Mazor X robotic system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05884593

2020H0434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Arm 1

Other group

Description:

Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system.

Treatment:

Device: Pedicle screw instrumentation using Mazor X robotic system