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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a robotic system called Mazor X, which assists doctors in placing screws more accurately in the spine during surgery. It targets individuals with spine issues, such as degenerative conditions or injuries between the T2 and S1 vertebrae. The trial aims to determine if the robot can guide the screws to the intended location. It is suitable for those requiring spinal surgery at The Ohio State University Wexner Medical Center for specific spine problems. As an unphased trial, it offers patients the chance to contribute to innovative surgical advancements.

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 prior data suggests that the Mazor X robotic system is safe for spinal surgery?

Research shows that robotic systems, such as the Mazor X Robotic System, hold promise for spine surgeries by helping to place screws precisely, a crucial aspect of these procedures. Studies comparing robotic systems indicate they improve accuracy and surgical outcomes, reducing mistakes during surgery.

However, some reports have noted complications. Specifically, after using the Mazor X system, six patients experienced wound issues within 90 days and required additional surgery to address these problems.

Overall, robotic systems in spinal surgery appear safe but carry some risks. They enhance surgical accuracy, but patients should be aware of potential complications. Patients should consult their doctor to understand the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mazor X Robotic System is unique because it brings a high level of precision and planning to spine surgery, which traditional methods can't match. Unlike standard surgical techniques, which rely heavily on the surgeon's skill and experience, this system allows for detailed preoperative planning and real-time guidance during surgery. Researchers are excited about this technology because it can potentially reduce complications, improve surgical outcomes, and shorten recovery times by enhancing accuracy and consistency in spinal procedures.

What evidence suggests that the Mazor X robotic system is effective for spinal conditions?

Research has shown that the Mazor X Robotic System enhances the accuracy of spinal surgeries by improving screw placement in the spine. Studies have found that this system reduces the likelihood of errors, which can occur up to 16.9% of the time with manual screw placement, particularly in challenging areas like the upper neck. Robotic assistance generally makes these surgeries safer and more precise. In this trial, all participants will undergo procedures using the Mazor X system, which is highly regarded in the medical community for reducing errors and improving surgical outcomes. Its capability to meticulously plan and execute surgeries makes it a promising tool for treating spinal issues. ^{1 2 3 6 7}

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

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?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05553028

Study Comparing Arthrodesis Technique of Thoracic and/ ... The aim of this study is to evaluate on a prospective randomized comparative study the quality of the placement of the screws as well as the occurrence of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12302903/

Clinical efficacy comparison of Mazor X robot-assisted and ... Relevant data indicate that the failure rate of freehand screw placement in the upper cervical spine is as high as 16.9%, and the incidence of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025000774

Robotic Systems in Spinal Surgery: A Review of Accuracy ... This review intends to provide a comprehensive comparison of clinically applied robotic systems in spine-based neurosurgery, including the Mazor robots by ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/os.14244

Evaluating the Status and Promising Potential of Robotic ... Development of Mazor family spinal robots, which is a representative of the development history of current robotic spinal surgery systems.

5. withpower.com withpower.com/trial/phase-neoplastic-processes-2-2021-23094

Robotic-Assisted Spine Surgery for Spinal Conditions Robotic-assisted spine surgery with the Mazor X system is generally considered safe, as it improves accuracy in procedures like screw placement and reduces ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11541143/

Evaluating the Status and Promising Potential of Robotic ... Robotic spinal surgery systems have emerged as a promising innovation, offering enhanced accuracy in screw placement and improved surgical outcomes.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=13615023&pc=OLO

MAUDE Adverse Event Report: MAZOR ROBOTICS LTD ... After use of the guidance system for lumbar arthrodesis, six patient experienced wound complications within 90 days after the surgery.A revision procedure was ...