50 Participants Needed

Robotic-Assisted Spine Surgery for Spinal Conditions

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is robotic-assisted spine surgery using the Mazor X system safe for humans?

Robotic-assisted spine surgery with the Mazor X system is generally considered safe, as it improves accuracy in procedures like screw placement and reduces radiation exposure for the surgical team. However, there is a learning curve for surgeons, and technical errors can occur, so proper training and understanding of the system are important to minimize risks.12345

How is the Mazor X Robotic System treatment different from other treatments for spinal conditions?

The Mazor X Robotic System is unique because it uses robotic assistance to improve the accuracy and precision of spine surgeries, such as placing screws in the spine. This technology allows for preoperative planning using CT scans to determine the safest and most effective surgical approach, which can lead to better outcomes and reduced radiation exposure compared to traditional methods.13678

What data supports the effectiveness of the treatment Mazor X Robotic System for spinal conditions?

Research shows that the Mazor X Robotic System improves the accuracy of placing pedicle screws (screws used to stabilize the spine) and reduces radiation exposure during spine surgeries, which are positive outcomes for both patients and surgeons.126910

Are You a Good Fit for This Trial?

This trial is for adults over 18 with conditions like scoliosis, spinal infections, trauma, cancer, or degenerative issues in the spine needing screws placed between T2-S1 vertebrae. Surgery must be done at The Ohio State University Wexner Medical Center by a study investigator.

Inclusion Criteria

My surgery will be done at OSUWMC by a study investigator.
I need screws in my spine due to a condition or injury between my upper back and tailbone.

Exclusion Criteria

Prisoner
I do not have severe heart, lung, or kidney diseases.
Subjects who are pregnant
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo posterior thoracolumbar arthrodesis procedures using the Mazor X robotic system

Surgery and immediate recovery
1 visit (in-person)

Follow-up

Participants are monitored for screw deviation and accuracy assessment post-surgery

6 weeks
Follow-up visits as needed

Study Completion

Final assessment of screw deviation and accuracy

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Mazor X Robotic System
Trial Overview The study tests how accurately pedicle screws can be inserted using the Mazor X robotic system during spine surgery. It measures any deviation from the planned screw path in thoracolumbar arthrodesis procedures.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
Geoff Martha profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Citations

Can Robotic Spine Surgery Become the Standard of Care? [2023]
Opportunities and challenges for robotic-assisted spine surgery: feasible indications for the MAZOR™ X Stealth Edition. [2023]
History and Evolution of Spinal Robotics in Pediatric Spinal Deformity. [2021]
Comparing Next-Generation Robotic Technology with 3-Dimensional Computed Tomography Navigation Technology for the Insertion of Posterior Pedicle Screws. [2019]
Accuracy and Efficiency of Fusion Robotics™ Versus Mazor-X™ in Single-Level Lumbar Pedicle Screw Placement. [2021]
Navigated Spinal Robotics in Minimally Invasive Spine Surgery, With Preoperative and Intraoperative Workflows: 2-Dimensional Operative Video. [2021]
Quad S2-Alar-Iliac Screw Fixation via Navigated Spinal Robotics With Software Planning: 2-Dimensional Operative Video. [2022]
Robotic-assisted cortical bone trajectory (CBT) screws using the Mazor X Stealth Edition (MXSE) system: workflow and technical tips for safe and efficient use. [2021]
Bone-mounted miniature robotic guidance for pedicle screw and translaminar facet screw placement: Part I--Technical development and a test case result. [2022]
10.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Results of using Spine Assist Mazor in surgical treatment of spine disorders]. [2018]
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