Spine Procedures Assisted With RoboTics And Navigation

Adolescent Idiopathic Scoliosis Clinical Trial

— SPARTAN  

Official title:

Spine Procedures Assisted With RoboTics And Navigation Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05071144
• Other study ID #: IRB-P00039760
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Idiopathic Scoliosis
• Neuromuscular Scoliosis
• Scoliosis
• Spine Deformity
• Spondylolisthesis

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