RecruitingNCT05608460Updated Nov 8, 2022

Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

An observational study in Cervical Spine Fracture, sponsored by University of Utah. Recruiting at 9 sites in United States. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University of Utah · Observational

From the registry’s dates

Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
Started Aug 2022; still recruiting 4 years 1 month later.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 15,700
Ages: 0 Years to 17 Years
Sex: All

Study 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 studied

Cervical Spine Fracture

Browse trials for

Spinal Fractures 164

In context

Spinal Fractures

164 studies on the registry are indexed under Spinal Fractures; 29 are open to participants now.

This study's planned enrollment of 15,700 is above the median of 130 across 57 observational studies indexed under Spinal Fractures.

Browse Spinal Fractures studies →

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 0 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Any participant less than 18 years old after blunt trauma

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

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 15,700 participants (estimated)
Target follow-up: 1 Month
Patient registry: Yes

What researchers measure

Primary outcomes

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

Study locations

1 of 9 sites recruiting

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05608460
Lead sponsor: University of Utah
Responsible party: Katie Russell, MD (Principal Investigator, University of Utah) — Principal investigator
First posted: Nov 8, 2022
Start date: Aug 15, 2022
Primary completion: Aug 15, 2025 (estimated)
Completion: Aug 15, 2025 (estimated)
Last update: Nov 8, 2022

Study contacts

Kezlyn Larsen, BS

Contact

kezlyn.larsen@hsc.utah.edu

801-662-2989

Katie Russell, MD

principal investigator · University of Utah

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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