Robotic-Assisted Surgery for Scoliosis
(ASPIRE Trial)
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.12345Why 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.13567
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo robotic spine surgery with data collection on operative time, blood loss, and screw placement accuracy
Follow-up
Participants are monitored for improvements in spinopelvic alignment and complete various questionnaires
What Are the Treatments Tested in This Trial?
Interventions
- Navigation-Assisted Spine Surgery
- Robotic Spine Surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
Pediatric Orthopaedic Society of North America
Collaborator
Medical University of South Carolina Shawn Jenkins Children's Hospital
Collaborator
Washington University School of Medicine
Collaborator
St. Luke's Medical Center
Collaborator
Medtronic
Industry Sponsor
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
Rainbow Babies and Children's Hospital
Collaborator
Hospital for Special Surgery, New York
Collaborator
Cedars-Sinai Medical Center
Collaborator
Citations
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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