Advanced SPinal Innovations With Robotics and Enabling Technology Registry
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Boston Children's Hospital
- Study ID
- NCT05071144
- Status
- Recruiting
Conditions
- Adolescent Idiopathic Scoliosis
- Congenital Scoliosis
- Idiopathic Scoliosis
- Neuromuscular Scoliosis
- Spine Deformity
- Spondylolisthesis
Eligibility Criteria
- Sex
- ALL
- Age
- 0 Years - 21 Years
- Healthy Volunteers
- Accepted
Study Details
Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.
Key Dates
- Start date
- Dec 13, 2021
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 700 participants (estimated)
Arms
- Arm: Pediatric Spine Deformity PatientsStandard of care surgery using robotics coupled with navigation and/or patient-specific rods
Primary Outcome Measure
proportion of pedicle screws within 2 mm of cortical breach [ Time Frame: Time of surgery ]
Central Contacts
- Maggie Sullivan, BS857-218-3272
- Sara Olenich, MS, CSCS
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | David Skaggs, MD David Skaggs, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Mark Erickson, MD Mark Erickson, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | Dennis Devito, MD Dennis Devito, MD (PRINCIPAL_INVESTIGATOR) |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | Daniel Hedequist, MD (PRINCIPAL_INVESTIGATOR) |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | Blake Montgomery, MD Blake Montgomery, MD (PRINCIPAL_INVESTIGATOR) |
| Hospital for Special Surgery | New York | New York | 10021 | Roger Widmann, MD Roger Widmann, MD (PRINCIPAL_INVESTIGATOR) Jessica Heyer, MD (SUB_INVESTIGATOR) |
| Rainbow Babies & Children's Hospital | Cleveland | Ohio | 44106 | Michael Glotzbecker, MD Michael Glotzbecker, MD (PRINCIPAL_INVESTIGATOR) |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | Dustin Greenhill, MD (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina Shawn Jenkins Children's Hospital | Charleston | South Carolina | 29425 | Robert Murphy, MD Robert Murphy, MD (PRINCIPAL_INVESTIGATOR) |
| Dell Children's Medical Center | Austin | Texas | 78723 | Kirsten Ross, MD Brian Kaufman, MD (PRINCIPAL_INVESTIGATOR) Kirsten Ross, MD (PRINCIPAL_INVESTIGATOR) |
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