Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

November 1, 2022 updated by: Katie Russell, MD, University of Utah
A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

15700

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Not yet recruiting
        • Phoenix Children's Hospital
        • Contact:
          • Melissa Nguyen
        • Principal Investigator:
          • Ben Padilla, MD
    • California
      • Los Angeles, California, United States, 90027
        • Not yet recruiting
        • Children's Hospital Los Angeles
        • Contact:
          • Laura Houshmand
        • Principal Investigator:
          • Lorraine Kelley-Quon, MD
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Rady Children's Hospital
        • Contact:
          • Romeo Ignacio, MD
        • Principal Investigator:
          • Romeo Ignacio, MD
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • UCSF Benioff Children's Hospital
        • Contact:
          • Aaron Jensen, MD
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Lucile Packard Children's Hospital
        • Contact:
          • Rachelle Balili
        • Principal Investigator:
          • Stephanie Chao, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Children's Hospital Colorado
        • Contact:
          • Connor Prendergast
        • Principal Investigator:
          • Shannon Acker, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health and Science University
        • Contact:
          • Andrew Mason
        • Principal Investigator:
          • Katrine Lofberg, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Maria Valencia
        • Principal Investigator:
          • Samir Pandya, MD
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • Primary Children's Hospital
        • Contact:
          • Kezlyn Larsen, BS

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

Ages Eligible for Study

1 second to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any participant less than 18 years old after blunt trauma

Description

Inclusion Criteria:

  • Any participant less than 18 years old after blunt trauma
  • Seen by trauma service
  • With cervical spine imaging (XR, CT, or MRI)

Exclusion Criteria:

  • CT scan from outside facility is poor quality and not repeated (<63-channel, cuts >3mm, no reformats, motion artifact)
  • No radiology over reads by participating institution

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Values of CT, XR, and MRI
Time Frame: 5 years
The sensitivity, specificity, negative and positive predictive values of CT, XR, and MRI for clinically significant injury will be calculated.
5 years

Collaborators and Investigators

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

Sponsor

University of Utah

Investigators

  • Principal Investigator: Katie Russell, MD, University of Utah

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)

August 15, 2022

Primary Completion (ANTICIPATED)

August 15, 2025

Study Completion (ANTICIPATED)

August 15, 2025

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (ACTUAL)

November 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-Spine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Cervical Spine Fracture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe