Advanced SPinal Innovations With Robotics and Enabling Technology Registry
ASPIRE
1 other identifier
observational
700
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2021
CompletedFirst Posted
Study publicly available on registry
October 8, 2021
CompletedStudy Start
First participant enrolled
December 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
March 11, 2026
March 1, 2026
9 years
September 7, 2021
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
radiation dose to patient and surgeon per screw
Time of surgery
Scoliosis Research Society (SRS-30) Questionnaire
Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
Early Onset Scoliosis 24-Item Questionnaire (EOSQ-24)
Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
Caregiver Priorities & Child Health Index of Life with Disabilities (CP Child)
Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity
Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
- +9 more secondary outcomes
Study Arms (1)
Pediatric Spine Deformity Patients
Standard of care surgery using robotics coupled with navigation and/or patient-specific rods
Eligibility Criteria
Study participants will be those receiving treatment for spinal deformity at one of the participating sites. Eligible patients will be identified from clinical databases of children undergoing surgery for spinal deformity.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Pediatric Orthopaedic Society of North Americacollaborator
- Medtroniccollaborator
- Children's Hospital Coloradocollaborator
- Hospital for Special Surgery, New Yorkcollaborator
- Children's Healthcare of Atlantacollaborator
- Dell Children's Medical Center of Central Texascollaborator
- Medical University of South Carolina Shawn Jenkins Children's Hospitalcollaborator
- University of Floridacollaborator
- Rainbow Babies and Children's Hospitalcollaborator
- Cedars-Sinai Medical Centercollaborator
- St. Luke's Medical Centercollaborator
Study Sites (10)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
Medical University of South Carolina Shawn Jenkins Children's Hospital
Charleston, South Carolina, 29425, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Hedequist, MD
Boston Children's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 7, 2021
First Posted
October 8, 2021
Study Start
December 13, 2021
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2031
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The sharing timeline is dependent on study investigators and will be considered after enrollment closure.
The data for this study may also be sent to the Pediatric Spine Foundation Study Group (PSSG) and/or the HARMS Study Group in the future. The study data may be stored in PSSG for use in future research studies conducted by the members of PSSG. To help protect participant confidentiality, any data we send to these groups will not include their name or any other identifying information. Data will be tagged with a study ID.