Recruiting

RoboTics & Navigation

Sponsor:

Boston Children's Hospital

Code:

NCT05071144

Conditions

Spine Deformity

Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis

Spondylolisthesis

Congenital Scoliosis

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Spine Deformity

Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis

Spondylolisthesis

Congenital Scoliosis

Study ID

NCT05071144

Start date

Dec 13, 2021

Status verified date

Jun, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

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 Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric Spine Deformity Patients

Standard of care surgery using robotics coupled with navigation and/or patient-specific rods

Primary outcome measure

  • proportion of pedicle screws within 2 mm of cortical breach [ Time Frame: Time of surgery ]

Central Contacts and Locations

Central contacts

Jessie Tonole, BA

857-218-3272Jessica.Tonole@childrens.harvard.edu

Sara Olenich, MS, CSCS

Sara.Olenich@childrens.harvard.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mark Erickson, MD

Mark.Erickson@childrenscolorado.org

Principal Investigator:

Mark Erickson, MD

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Dennis Devito, MD

Dennis.Devito@choa.org

Principal Investigator:

Dennis Devito, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sara Olenich, MS, CSCS

857-218-3272sara.olenich@childrens.harvard.edu

Danielle DiPersio

617-919-1632danielle.dipersio@childrens.harvard.edu

Principal Investigator:

Daniel Hedequist, MD

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Roger Widmann, MD

WidmannR@HSS.EDU

Principal Investigator:

Roger Widmann, MD

St. Luke's University Health Network

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Dustin Greenhill, MD

(484) 526-1735dustin.greenhill@sluhn.org

Principal Investigator:

Dustin Greenhill, MD

Medical University of South Carolina Shawn Jenkins Children's Hospital

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Robert Murphy, MD

murphyr@musc.edu

Principal Investigator:

Robert Murphy, MD

Dell Children's Medical Center

Recruiting

Austin, Texas, United States, 78723

Contacts

Kirsten Ross, MD

kross@ctpomd.com

Principal Investigator:

Brian Kaufman, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Pediatric
  • Spine
  • Surgery
  • Registry
  • Robotic
  • Navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-06-22.