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

June 18, 2026 updated by: Daniel Hedequist, Boston Children's Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Not yet recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • David Skaggs, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Children's Healthcare of Atlanta
        • Principal Investigator:
          • Dennis Devito, MD
        • Contact:
    • Massachusetts
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • St. Louis Children's Hospital
        • Contact:
        • 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:
        • 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:
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Health Network
        • Contact:
        • Principal Investigator:
          • Dustin Greenhill, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina Shawn Jenkins Children's Hospital
        • Contact:
        • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
proportion of pedicle screws within 2 mm of cortical breach
Time Frame: Time of surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
radiation dose to patient and surgeon per screw
Time Frame: Time of surgery
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
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
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)
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
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)
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
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
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
"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
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
"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
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
"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
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
"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
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
"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
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
"Quality of relationships with friends and other acquaintances."
Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
Operative time
Time Frame: Time of surgery
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)
Time Frame: Time of surgery
EBL during surgery will be reported by the surgeon or extracted from surgical documentation.
Time of surgery
Total operative cost
Time Frame: Time of surgery
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
Time Frame: Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital Colorado
University of Florida
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Hedequist, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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