Advanced SPinal Innovations With Robotics and Enabling Technology Registry (ASPIRE)

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis; Idiopathic Scoliosis; Spondylolisthesis; Spine Deformity; Neuromuscular Scoliosis; Congenital Scoliosis

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Maggie Sullivan, BS; Phone Number: 857-218-3272; Email: Maggie.Sullivan@childrens.harvard.edu
• Study Contact Backup: Name: Sara Olenich, MS, CSCS; Email: Sara.Olenich@childrens.harvard.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Not yet recruiting
      • Cedars-Sinai Medical Center
      • Contact: David Skaggs, MD; Email: David.Skaggs@cshs.org
      • Principal Investigator: David Skaggs, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Principal Investigator: Mark Erickson, MD
      • Contact: Mark Erickson, MD; Email: Mark.Erickson@childrenscolorado.org
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Children's Healthcare of Atlanta
      • Principal Investigator: Dennis Devito, MD
      • Contact: Dennis Devito, MD; Email: Dennis.Devito@choa.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Principal Investigator: Daniel Hedequist, MD
      • Contact: Sara Olenich, MS, CSCS; Phone Number: 857-218-3272; Email: sara.olenich@childrens.harvard.edu
      • Contact: Danielle DiPersio; Phone Number: 617-919-1632; Email: danielle.dipersio@childrens.harvard.edu
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Not yet recruiting
      • St. Louis Children's Hospital
      • Contact: Blake Montgomery, MD; Email: montgomeryb7@gmail.com
      • Principal Investigator: Blake Montgomery, MD
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Principal Investigator: Roger Widmann, MD
      • Contact: Roger Widmann, MD; Email: WidmannR@HSS.EDU
      • Sub-Investigator: Jessica Heyer, MD
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Rainbow Babies & Children's Hospital
      • Principal Investigator: Michael Glotzbecker, MD
      • Contact: Michael Glotzbecker, MD; Email: Michael.Glotzbecker@UHhospitals.org
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Recruiting
      • St. Luke's University Health Network
      • Principal Investigator: Dustin Greenhill, MD
      • Contact: Dustin Greenhill, MD; Phone Number: 484-526-1735; Email: dustin.greenhill@sluhn.org
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina Shawn Jenkins Children's Hospital
      • Contact: Robert Murphy, MD; Email: murphyr@musc.edu
      • Principal Investigator: Robert Murphy, MD
  • Texas
    • Austin, Texas, United States, 78723
      • Recruiting
      • Dell Children's Medical Center
      • Principal Investigator: Kirsten Ross, MD
      • Principal Investigator: Brian Kaufman, MD
      • Contact: Kirsten Ross, MD; Email: kross@ctpomd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 17 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pediatric Spine Deformity Patients; Standard of care surgery using robotics coupled with navigation and/or patient-specific rods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
Estimated blood loss (EBL)	EBL during surgery will be reported by the surgeon or extracted from surgical documentation.	Time of surgery
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
Improvement to spinopelvic alignment with PSR	Spinopelvic alignment parameters including pelvic tilt, pelvic incidence, lumbar lordosis, thoracic kyphosis and sagittal vertical axis	Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Children's Hospital Colorado; University of Florida; Cedars-Sinai Medical Center; Hospital for Special Surgery, New York; Medtronic; Children's Healthcare of Atlanta; Dell Children's Medical Center of Central Texas; Pediatric Orthopaedic Society of North America; Rainbow Babies and Children's Hospital; St. Luke's Medical Center; Medical University of South Carolina Shawn Jenkins Children's Hospital
• Investigators: Principal Investigator: Daniel Hedequist, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Surgery; Pediatric; Registry; Robotic; Navigation; Spine
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: IRB-P00039760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The sharing timeline is dependent on study investigators and will be considered after enrollment closure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No