Spine Procedures Assisted With RoboTics And Navigation

Study Purpose

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 0 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of a spine deformity.
  • - Scheduled for surgery using robotics and navigation.
  • - Up to and including 21 years of age.
  • - Speak and read English or Spanish.

Exclusion Criteria:

• None

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05071144
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boston Children's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Daniel Hedequist, MD
Principal Investigator Affiliation Boston Children's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spine Deformity, Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Spondylolisthesis, Congenital Scoliosis, Neuromuscular Scoliosis
Arms & Interventions

Arms

: Pediatric Spine Deformity Patients

Standard of care surgery using robotics coupled with navigation

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Medical Center, Los Angeles, California

Status

Not yet recruiting

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Site Contact

David Skaggs, MD

[email protected]

857-218-3272

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Site Contact

Mark Erickson, MD

[email protected]

857-218-3272

Children's Healthcare of Atlanta, Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342

Site Contact

Dennis Devito, MD

[email protected]

857-218-3272

Boston Children's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

Site Contact

Nicole Welch, BA

[email protected]

857-218-3272

St. Louis Children's Hospital, Saint Louis, Missouri

Status

Not yet recruiting

Address

St. Louis Children's Hospital

Saint Louis, Missouri, 63110

Site Contact

Blake Montgomery, MD

[email protected]

857-218-3272

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Roger Widmann, MD

[email protected]

857-218-3272

Rainbow Babies & Children's Hospital, Cleveland, Ohio

Status

Not yet recruiting

Address

Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106

Site Contact

Michael Glotzbecker, MD

[email protected]

857-218-3272

Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina Shawn Jenkins Children's Hospital

Charleston, South Carolina, 29425

Site Contact

Robert Murphy, MD

[email protected]

857-218-3272

Dell Children's Medical Center, Austin, Texas

Status

Recruiting

Address

Dell Children's Medical Center

Austin, Texas, 78723

Site Contact

Kirsten Ross, MD

[email protected]

857-218-3272