Spine Procedures Assisted with RoboTics and Navigation
- Conditions
- Spine DeformityIdiopathic ScoliosisAdolescent Idiopathic ScoliosisSpondylolisthesisCongenital ScoliosisNeuromuscular Scoliosis
- Registration Number
- NCT05071144
- Lead Sponsor
- Boston Children's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
• None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of pedicle screws within 2 mm of cortical breach Time of surgery 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 Outcome Measures
Name Time Method Estimated blood loss (EBL) Time of surgery EBL during surgery will be reported by the surgeon or extracted from surgical documentation.
radiation dose to patient and surgeon per screw Time of surgery 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 Baseline, 6 Months, 1 Year, 2 Years, and 5 Years 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) Baseline, 6 Months, 1 Year, 2 Years, and 5 Years 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) Baseline, 6 Months, 1 Year, 2 Years, and 5 Years Questionnaires will be completed by both the patient and caregiver based on their appropriate diagnosis (i.e. idiopathic, congenital, spondylolisthesis, etc.).
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity Baseline, 6 Months, 1 Year, 2 Years, and 5 Years "Self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living."
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety Baseline, 6 Months, 1 Year, 2 Years, and 5 Years "Fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness)."
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depressive Symptoms Baseline, 6 Months, 1 Year, 2 Years, and 5 Years "Negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose)."
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Mobility Baseline, 6 Months, 1 Year, 2 Years, and 5 Years "Activities of physical mobility such as getting out of bed or a chair to activities such as running."
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain - Interference Baseline, 6 Months, 1 Year, 2 Years, and 5 Years "Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities."
Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships Baseline, 6 Months, 1 Year, 2 Years, and 5 Years "Quality of relationships with friends and other acquaintances."
Total operative cost Time of surgery Capital expenses associated with the equipment and software, preoperative planning time, surgical time, and costs for revision surgery caused by screw malposition.
Improvement to spinopelvic alignment with PSR Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years Spinopelvic alignment parameters including pelvic tilt, pelvic incidence, lumbar lordosis, thoracic kyphosis and sagittal vertical axis
Operative time Time of surgery Data collection on time related to robotics-navigation, including registration, screw planning, screw placement, and total time related to platform use defined as the beginning of registration to last screw placement.
Trial Locations
- Locations (9)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Rainbow Babies & Children's Hospital
🇺🇸Cleveland, Ohio, United States
Medical University of South Carolina Shawn Jenkins Children's Hospital
🇺🇸Charleston, South Carolina, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States