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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05071144
Other study ID # IRB-P00039760
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2021
Est. completion date December 2031

Study information

Verified date October 2023
Source Boston Children's Hospital
Contact Nicole Welch, BA
Phone 857-218-3272
Email Nicole.Welch@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Locations

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

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

Outcome

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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