Cervical Spine Fracture Clinical Trial
Official title:
Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study
| NCT number | NCT05608460 |
| Other study ID # | C-Spine |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 15, 2022 |
| Est. completion date | August 15, 2025 |
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.
| Status | Recruiting |
| Enrollment | 15700 |
| Est. completion date | August 15, 2025 |
| Est. primary completion date | August 15, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 0 Years to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Hospital Colorado | Aurora | Colorado |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Children's Hospital Los Angeles | Los Angeles | California |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Primary Children's Hospital | Salt Lake City | Utah |
| United States | Rady Children's Hospital | San Diego | California |
| United States | UCSF Benioff Children's Hospital | San Francisco | California |
| United States | Lucile Packard Children's Hospital | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of Utah |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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