Cervical Spine FractureNCT05608460
Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study
An observational study of Cervical Spine Fracture, run by University of Utah at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Cervical Spine Fracture
- How many people
- 15,700 participants
- Where
- 9 sitesUnited States
- Study dates
- 15 Aug 2022to 15 Aug 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Any participant less than 18 years old after blunt trauma
Who may be able to join
- Any participant less than 18 years old after blunt trauma
- Seen by trauma service
- With cervical spine imaging (XR, CT, or MRI)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites, 9 recruiting
- Not yet recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Connor Prendergast
Shannon Acker, MD
- Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Maria Valencia
Samir Pandya, MD
- Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Laura Houshmand
Lorraine Kelley-Quon, MD
- Not yet recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Melissa Nguyen
Ben Padilla, MD
- Not yet recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Andrew Mason
Katrine Lofberg, MD
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Kezlyn Larsen, BS
Katie Russell, MD
- Not yet recruiting
Rady Children's Hospital
San Diego, California, 92123
Romeo Ignacio, MD
Romeo Ignacio, MD
- Not yet recruiting
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Aaron Jensen, MD
Aaron Jensen, MD
- Not yet recruiting
Lucile Packard Children's Hospital
Stanford, California, 94305
Rachelle Balili
Stephanie Chao, MD
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start15 Aug 2022
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,700 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Russell, MD, University of Utah
- Investigators
- Katie Russell, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608460
- Sponsor's protocol ID
- C-Spine
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05608460
- Acronym / sponsor ID
- C-Spine
- Conditions
- Cervical Spine Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,700 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any participant less than 18 years old after blunt trauma
Key inclusion criteria (3 listed)
- Any participant less than 18 years old after blunt trauma
- Seen by trauma service
- With cervical spine imaging (XR, CT, or MRI)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Russell, MD principal investigator
University of Utah
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spine Fracture, run by University of Utah at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kezlyn Larsen, BS (801-662-2989, kezlyn.larsen@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Values of CT, XR, and MRI (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.