Actively Recruiting
Advanced SPinal Innovations With Robotics and Enabling Technology Registry
Led by Boston Children's Hospital · Updated on 2026-03-11
700
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
P
Pediatric Orthopaedic Society of North America
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to create a pediatric robotic spine surgery registry to collect and analyze data on the combined use of robotics and navigation, along with patient-specific rods, in surgeries for pediatric spine deformities. The study includes patients diagnosed with various spine deformities such as idiopathic scoliosis, adolescent idiopathic scoliosis, spondylolisthesis, congenital scoliosis, and neuromuscular scoliosis. The goal is to establish an educational and informative framework for this technology across participating institutions. Participants will undergo standard-of-care spine deformity surgery that uses robotics coupled with navigation and/or patient-specific rods. The study focuses on observing these surgeries without introducing experimental treatments. Data will be gathered during surgery and at follow-up intervals to assess surgical precision and outcomes. During the study, researchers will track the precision of pedicle screw placement within 2 mm of cortical breach during surgery. They will also measure radiation exposure to patients and surgeons, operative time, blood loss, and total operative cost. Participants will complete several questionnaires at baseline, 6 months, 1 year, 2 years, and 5 years to evaluate physical activity, emotional distress, pain interference, peer relationships, and quality of life. The study follows participants for up to five years to monitor improvements in spine alignment and other health outcomes.
CONDITIONS
Brief Title
Advanced SPinal Innovations With Robotics and Enabling Technology Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a spine deformity
- Scheduled for surgery using robotics and navigation and/or patient-specific rods
- Up to and including 21 years of age
- Speak and read English or Spanish
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus hospital stay duration
Participants undergo standard of care spine deformity surgery using robotics coupled with navigation and/or patient-specific rods, followed by immediate post-operative care.
1 surgery visit and post-operative hospital care
Duration - Up to 5 years
Participants are followed up to assess recovery, spine alignment, and patient-reported outcomes.
Visits at baseline, 6 months, 1 year, 2 years, and 5 years
Trial Site Locations
Total: 10 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Actively Recruiting
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Not Yet Recruiting
6
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
7
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
8
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
9
Medical University of South Carolina Shawn Jenkins Children's Hospital
Charleston, South Carolina, United States, 29425
Actively Recruiting
10
Dell Children's Medical Center
Austin, Texas, United States, 78723
Actively Recruiting
Research Team
M
Maggie Sullivan, BS
S
Sara Olenich, MS, CSCS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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