Registry for pediatric spine surgeries using robotics and navigation
Advanced SPinal Innovations With Robotics and Enabling Technology Registry
This study is creating a registry to track pediatric spine surgeries that use robotics and navigation to see how these advanced techniques can improve treatment for kids with spine deformities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 0 Years to 21 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT05071144 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a registry for pediatric spine surgeries that utilize robotics and navigation, as well as patient-specific rods. By collecting and analyzing data from various participating institutions, the study seeks to enhance understanding of these advanced surgical techniques in treating spine deformities. The ultimate goal is to establish an educational framework that informs best practices and improves surgical outcomes for pediatric patients. The study focuses on conditions such as idiopathic scoliosis and spondylolisthesis among patients up to 21 years of age.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients diagnosed with a spine deformity who are scheduled for surgery involving robotics and navigation.
Not a fit: Patients who do not have a spine deformity or are not undergoing surgery using the specified technologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and enhanced treatment protocols for pediatric patients with spine deformities.
How similar studies have performed: While the use of robotics in spine surgery is gaining traction, this specific registry approach is relatively novel and aims to gather comprehensive data for future advancements.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: • None
Where this trial is running
Los Angeles, California and 9 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Not_yet_recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- St. Louis Children's Hospital — St Louis, Missouri, United States (Not_yet_recruiting)
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
- Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States (Not_yet_recruiting)
- St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina Shawn Jenkins Children's Hospital — Charleston, South Carolina, United States (Recruiting)
- Dell Children's Medical Center — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Hedequist, MD — Boston Children's Hospital
- Study coordinator: Maggie Sullivan, BS
- Email: Maggie.Sullivan@childrens.harvard.edu
- Phone: 857-218-3272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.