Spine DeformityASPIRENCT05071144
Advanced SPinal Innovations With Robotics and Enabling Technology Registry
An observational study of Spine Deformity and Idiopathic Scoliosis, run by Boston Children's Hospital at 10 sites in United States.
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, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Read more about this study
- Who is it for?
- Ages 0 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine Deformity, Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis
- How many people
- 700 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Dec 2021to Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Olenich, MS, CSCS contact
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Dennis Devito, MD, Dennis.Devito@choa.org
Dennis Devito, MD
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Mark Erickson, MD, Mark.Erickson@childrenscolorado.org
Mark Erickson, MD
- Recruiting
Dell Children's Medical Center
Austin, Texas, 78723
Kirsten Ross, MD, kross@ctpomd.com
Brian Kaufman, MD
- Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Dustin Greenhill, MD, (484) 526-1735, dustin.greenhill@sluhn.org
Dustin Greenhill, MD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Sara Olenich, MS, CSCS, 857-218-3272, sara.olenich@childrens.harvard.edu
Danielle DiPersio, 617-919-1632, danielle.dipersio@childrens.harvard.edu
- Recruiting
Medical University of South Carolina Shawn Jenkins Children's Hospital
Charleston, South Carolina, 29425
Robert Murphy, MD, murphyr@musc.edu
Robert Murphy, MD
- Not yet recruiting
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Michael Glotzbecker, MD, Michael.Glotzbecker@UHhospitals.org
Michael Glotzbecker, MD
- Not yet recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
David Skaggs, MD, David.Skaggs@cshs.org
David Skaggs, MD
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Roger Widmann, MD, WidmannR@HSS.EDU
Roger Widmann, MD
- Not yet recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
Blake Montgomery, MD, montgomeryb7@gmail.com
Blake Montgomery, MD
About this study
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.
- Conditions
- Spine Deformity, Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Spondylolisthesis, Congenital Scoliosis, Neuromuscular Scoliosis
- Keywords
- Pediatric, Spine, Surgery, Registry, Robotic, Navigation
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Spine Deformity Patients | Standard of care surgery using robotics coupled with navigation and/or patient-specific rods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Time of surgery
Secondary outcomes (14)
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.
Measured: 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.).
Measured: 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.).
Measured: 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.).
Measured: 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."
Measured: 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)."
Measured: 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)."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: Time of surgery
Estimated blood loss (EBL)
EBL during surgery will be reported by the surgeon or extracted from surgical documentation.
Measured: 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.
Measured: 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
Measured: Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start13 Dec 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DeformityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Orthopaedic Society of North America, Medtronic, Children's Hospital Colorado, Hospital for Special Surgery, New York, Children's Healthcare of Atlanta, Rainbow Babies and Children's Hospital, Dell Children's Medical Center of Central Texas, Medical University of South Carolina Shawn Jenkins Children's Hospital, St. Luke's Medical Center, University of Florida
- Responsible party
- Principal investigator, Daniel Hedequist, Boston Children's Hospital
- Investigators
- Daniel Hedequist, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071144
- Sponsor's protocol ID
- IRB-P00039760
- Acronym
- ASPIRE
- Status last verified
- Jun 2026
- First submitted
- 7 Sep 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced SPinal Innovations With Robotics and Enabling Technology Registry
- ClinicalTrials.gov ID
- NCT05071144
- Acronym / sponsor ID
- ASPIRE / IRB-P00039760
- Conditions
- Spine Deformity, Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Spondylolisthesis, Congenital Scoliosis, Neuromuscular Scoliosis
- Keywords
- Pediatric, Spine, Surgery, Registry, Robotic, Navigation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Pediatric Orthopaedic Society of North America, Medtronic, Children's Hospital Colorado, Hospital for Special Surgery, New York, Children's Healthcare of Atlanta, Rainbow Babies and Children's Hospital, Dell Children's Medical Center of Central Texas, Medical University of South Carolina Shawn Jenkins Children's Hospital, St. Luke's Medical Center, University of Florida
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Spine Deformity Patients | – | –Standard of care surgery using robotics coupled with navigation and/or patient-specific rods |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
14 secondary outcomes
radiation dose to patient and surgeon per screw
Time frame: Time of surgery
Scoliosis Research Society (SRS-30) Questionnaire
Time frame: 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
Caregiver Priorities & Child Health Index of Life with Disabilities (CP Child)
Time frame: 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
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety
Time frame: 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
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Mobility
Time frame: 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
Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships
Time frame: Baseline, 6 Months, 1 Year, 2 Years, and 5 Years
Operative time
Time frame: Time of surgery
Estimated blood loss (EBL)
Time frame: Time of surgery
Total operative cost
Time frame: Time of surgery
Improvement to spinopelvic alignment with PSR
Time frame: Baseline, Predicted plan, 6 months, 1 year, 2 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Spine Deformity
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
ASD, Scoliosis Idiopathic Adolescent
Active, not recruitingObservational study
Real-World Effectiveness of Conservative Treatment in Idiopathic Scoliosis
Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
Active, not recruiting
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Pain, Postoperative, Excavatum, Pectus
Active, not recruitingObservational study
Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Scoliosis, Kyphosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Olenich, MS, CSCS contact
Daniel Hedequist, MD principal investigator
Boston Children's Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Deformity and Idiopathic Scoliosis, run by Boston Children's Hospital at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessie Tonole, BA (857-218-3272, Jessica.Tonole@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of pedicle screws within 2 mm of cortical breach (time frame: Time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.