Adolescent Idiopathic Scoliosis, Congenital Scoliosis, Idiopathic Scoliosis, Neuromuscular Scoliosis, Spine Deformity, Spondylolisthesis
Conditions
Keywords
Pediatric, Spine, Surgery, Registry, Robotic, Navigation
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.
Interventions
None listed
Sponsors
Boston Children's Hospital
Pediatric Orthopaedic Society of North America
Medtronic
Children's Hospital Colorado
Hospital for Special Surgery, New York
Children's Healthcare of Atlanta
Rainbow Babies and Children's Hospital
Dell Children's Medical Center of Central Texas
Medical University of South Carolina Shawn Jenkins Children's Hospital
St. Luke's Medical Center
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 21 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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." |
| 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. |
| Estimated blood loss (EBL) | Time of surgery | EBL during surgery will be reported by the surgeon or extracted from surgical documentation. |
| 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 |
Countries
United States
Contacts
CONTACTJessie Tonole, BA
CONTACTSara Olenich, MS, CSCS
PRINCIPAL_INVESTIGATORDaniel Hedequist, MD
Boston Children's Hospital
Outcome results
None listed