About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Study participants will be those receiving treatment for spinal deformity at one of the participating sites. Eligible patients will be identified from clinical databases of children undergoing surgery for spinal deformity.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
proportion of pedicle screws within 2 mm of cortical breach
The proportion of pedicle screws within 2 mm of cortical breach when assessed on intraoperative O-arm scans and postoperative CT scans (when applicable).
Secondary outcomes
radiation dose to patient and surgeon per screw
Radiation dose to patient and surgeon per screw based on the following imaging studies when performed: preoperative CT scan, intraoperative O-arm scans, and fluoroscopy.
Scoliosis Research Society (SRS-30) Questionnaire
Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.).
Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24)
Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.).
Caregiver Priorities & Child Health Index of Life with Disabilities (CP Child)
Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Children's Hospital
Lead sponsor
Pediatric Orthopaedic Society of North America
Collaborator
Medtronic
Collaborator
Children's Hospital Colorado
Collaborator
Hospital for Special Surgery, New York
Collaborator
Children's Healthcare of Atlanta
Collaborator
Rainbow Babies and Children's Hospital
Collaborator
Dell Children's Medical Center of Central Texas
Collaborator
Medical University of South Carolina Shawn Jenkins Children's Hospital
Collaborator
St. Luke's Medical Center
Collaborator
University of Florida
Collaborator