Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT05608460

Conditions

Cervical Spine Fracture

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Cervical Spine Fracture

Study ID

NCT05608460

Start date

Aug 15, 2022

Status verified date

Nov, 2022

Completion date

Aug 15, 2025

Anticipated

Primary completion date

Aug 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

15700 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Predictive Values of CT, XR, and MRI [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Kezlyn Larsen, BS

801-662-2989kezlyn.larsen@hsc.utah.edu

Locations

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Principal Investigator:

Katie Russell, MD

More Information

Sponsor

University of Utah

Last update posted

Nov 8, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2022-11-08.