Robotic-Assisted Spine Surgery for Spinal Conditions

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Spinal tumor, Severe co-morbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery and immediate recovery

50 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{2 4 6 9 10}

Eligibility Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

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

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

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Can Robotic Spine Surgery Become the Standard of Care? [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Opportunities and challenges for robotic-assisted spine surgery: feasible indications for the MAZOR™ X Stealth Edition. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

History and Evolution of Spinal Robotics in Pediatric Spinal Deformity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Comparing Next-Generation Robotic Technology with 3-Dimensional Computed Tomography Navigation Technology for the Insertion of Posterior Pedicle Screws. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Accuracy and Efficiency of Fusion Robotics™ Versus Mazor-X™ in Single-Level Lumbar Pedicle Screw Placement. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Navigated Spinal Robotics in Minimally Invasive Spine Surgery, With Preoperative and Intraoperative Workflows: 2-Dimensional Operative Video. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Quad S2-Alar-Iliac Screw Fixation via Navigated Spinal Robotics With Software Planning: 2-Dimensional Operative Video. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

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]