Robotic-Assisted Surgery for Scoliosis

(SPARTAN Trial)

Recruiting at 10 trial locations

Overseen By Sara Olenich, MS, CSCS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

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

Compensation: Varies

Number of Visits: 6

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how robotic and navigation technology can improve spine surgery for children and young adults with spine deformities, such as scoliosis. The goal is to gather data to create a guide for using these advanced tools in surgeries. Participants must have a diagnosed spine deformity and be scheduled for surgery using robotics or special rods. This trial is suitable for those who speak English or Spanish and are 21 years old or younger. As an unphased trial, it offers participants the opportunity to contribute to pioneering research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

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

What prior data suggests that navigation-assisted and robotic spine surgeries are safe for pediatric patients?

A previous study found that spine surgeries using navigation technology had lower risks of complications, such as excessive blood loss and kidney issues. These surgeries also had very low mortality rates, with very few deaths reported. However, they took slightly longer to perform.

Research has shown that robotic spine surgery is generally safe and effective. One study demonstrated that screw placement was highly accurate, which is crucial for successful surgery. Few complications occurred during or after these surgeries.

Overall, both navigation-assisted and robotic spine surgeries appear safe and well-tolerated, with few serious issues reported. This suggests they are viable options for treating spine problems in patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of robotics and navigation-assisted methods in spine surgery because these technologies offer greater precision and control compared to traditional techniques. Unlike standard spine surgeries, which rely heavily on the surgeon's skill and experience, these advanced methods use real-time imaging and robotic systems to enhance accuracy. This can potentially lead to fewer complications, quicker recovery times, and improved outcomes for patients. By integrating cutting-edge technology into the surgical process, these methods aim to enhance the safety and effectiveness of spine surgeries.

What evidence suggests that navigation-assisted and robotic spine surgery are effective for pediatric spine deformity?

This trial will compare Navigation-Assisted Spine Surgery with Robotic Spine Surgery. Studies have shown that navigation tools in spine surgery can improve outcomes by increasing accuracy and efficiency. In one group of patients, computer-guided navigation significantly enhanced the precision of surgical instrument placement. Research indicates that robotic spine surgery, approved by the FDA in 2004, achieves very precise placement, with an error of less than 2mm in 98% of cases. Early findings suggest that combining navigation and robotic assistance can further enhance surgical precision, reducing the risk of complications. Both techniques, whether used alone or together, have shown promise in making spine surgeries safer and more effective. ^{1 3 5 6 7}

Who Is on the Research Team?

Daniel Hedequist, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

You are scheduled for robotic and navigated surgery.

You are proficient in either English or Spanish, both verbally and literately.

You are up to 21 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo robotic spine surgery with data collection on operative time, blood loss, and screw placement accuracy

Time of surgery

Follow-up

Participants are monitored for improvements in spinopelvic alignment and complete various questionnaires

5 years

Baseline, 6 months, 1 year, 2 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Spine Surgery
• Navigation-Assisted Spine Surgery

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Pediatric Orthopaedic Society of North America

Collaborator

Trials

8

Recruited

1,500+

Medical University of South Carolina Shawn Jenkins Children's Hospital

Collaborator

Trials

2

Recruited

760+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

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

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Rainbow Babies and Children's Hospital

Collaborator

Trials

9

Recruited

4,000+

Hospital for Special Surgery, New York

Collaborator

Trials

257

Recruited

61,800+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Medical University of South Carolina Shawn Jenkins Children's Hospital

Collaborator

Trials

1

Recruited

600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7859779/

Current state of navigation in spine surgery - PMC In their cohort of 40 patients undergoing posterior lumbar fusion, their study found an average effective dose of 0.4 mGy in the computer assisted navigation ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590139725000870

Robotic Spine Fusion Bridges the Surgeon Learning Gap Robotic assisted spine surgery was first FDA approved in 2004 with an average error of <2mm in 98% of pedicle screws4, 5, 6. Since then, Robotic ...

3. e-neurospine.org e-neurospine.org/journal/view.php?number=1543

Navigation-Guided/Robot-Assisted Spinal Surgery The development of minimally invasive spinal surgery utilizing navigation and robotics has significantly improved the feasibility, accuracy, and efficiency of ...

4. ijssurgery.com ijssurgery.com/content/19/4/437

Ninety-Day Complication and Revision Surgery Rates ... Individually, robotic guidance and real-time 3D navigation assistance have both been shown to improve surgical outcomes, instrumentation placement accuracy, and ...

5. mdpi.com mdpi.com/2077-0383/13/16/4663

The Impact of Navigation in Lumbar Spine Surgery A concise overview of navigation system history in lumbar spine surgeries, the techniques involved, the advantages and disadvantages, and suggestions for ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875022000389

Intraoperative Navigation in Spine Surgery Interestingly, while navigation as a whole was associated with 20.8% longer intraoperative times, posterior cervical fusions were found to have 35.6% longer ...

7. link.springer.com link.springer.com/article/10.1007/s00586-025-09060-z

robotic-assisted versus navigation-guided approaches Both showed minimal mortality rates. Navigation-guided surgeries had lower charges, lower risks of blood loss anemia, acute kidney injury, and ...