Advanced SPinal Innovations With Robotics and Enabling Technology Registry

NCT ID: NCT05071144

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-13

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spine Deformity Idiopathic Scoliosis Adolescent Idiopathic Scoliosis Spondylolisthesis Congenital Scoliosis Neuromuscular Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric Spine Deformity Patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pediatric Orthopaedic Society of North America

OTHER

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

Children's Hospital Colorado

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role collaborator

Children's Healthcare of Atlanta

OTHER

Sponsor Role collaborator

Rainbow Babies and Children's Hospital

OTHER

Sponsor Role collaborator

Dell Children's Medical Center of Central Texas

OTHER

Sponsor Role collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role collaborator

Medical University of South Carolina Shawn Jenkins Children's Hospital

OTHER

Sponsor Role collaborator

St. Luke's Medical Center

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daniel Hedequist

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Hedequist, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status NOT_YET_RECRUITING

Hospital for Special Surgery

New York, New York, United States

Site Status RECRUITING

Rainbow Babies & Children's Hospital

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

Medical University of South Carolina Shawn Jenkins Children's Hospital

Charleston, South Carolina, United States

Site Status RECRUITING

Dell Children's Medical Center

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maggie Sullivan, BS

Role: CONTACT

857-218-3272

Sara Olenich, MS, CSCS

Role: CONTACT

Facility Contacts

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David Skaggs, MD

Role: primary

Mark Erickson, MD

Role: primary

Dennis Devito, MD

Role: primary

Sara Olenich, MS, CSCS

Role: primary

857-218-3272

Danielle DiPersio

Role: backup

617-919-1632

Blake Montgomery, MD

Role: primary

Roger Widmann, MD

Role: primary

Michael Glotzbecker, MD

Role: primary

Dustin Greenhill, MD

Role: primary

(484) 526-1735

Robert Murphy, MD

Role: primary

Kirsten Ross, MD

Role: primary

Other Identifiers

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IRB-P00039760

Identifier Type: -

Identifier Source: org_study_id

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