Adolescent Idiopathic Scoliosis Clinical Trial
— SPARTANOfficial title:
Spine Procedures Assisted With RoboTics And Navigation Registry
Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2031 |
Est. primary completion date | December 2030 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 0 Years to 21 Years |
Eligibility | Inclusion Criteria: - Diagnosis of a spine deformity - Scheduled for surgery using robotics and navigation - Up to and including 21 years of age - Speak and read English or Spanish Exclusion Criteria: • None |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Dell Children's Medical Center | Austin | Texas |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Medical University of South Carolina Shawn Jenkins Children's Hospital | Charleston | South Carolina |
United States | Rainbow Babies & Children's Hospital | Cleveland | Ohio |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Hospital for Special Surgery | New York | New York |
United States | St. Louis Children's Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Cedars-Sinai Medical Center, Children's Healthcare of Atlanta, Children's Hospital Colorado, Dell Children's Medical Center of Central Texas, Hospital for Special Surgery, New York, Medical University of South Carolina Shawn Jenkins Children's Hospital, Medtronic, Pediatric Orthopaedic Society of North America, Rainbow Babies and Children's Hospital, St. Louis Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Time of surgery | |
Secondary | 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. | Time of surgery | |
Secondary | 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.). | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | 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.). | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | 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.). | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity | "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." | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety | "Fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness)." | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depressive Symptoms | "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)." | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Mobility | "Activities of physical mobility such as getting out of bed or a chair to activities such as running." | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain - Interference | "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." | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships | "Quality of relationships with friends and other acquaintances." | Baseline, 6 Months, 1 Year, 2 Years, and 5 Years | |
Secondary | Operative time | 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. | Time of surgery | |
Secondary | Estimated blood loss (EBL) | EBL during surgery will be reported by the surgeon or extracted from surgical documentation. | Time of surgery | |
Secondary | Total operative cost | Capital expenses associated with the equipment and software, preoperative planning time, surgical time, and costs for revision surgery caused by screw malposition. | Time of surgery |
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