The purpose of this study is to test the accuracy of using RNA in blood as a way to forecast new fracture healing outcome.
This study will follow a registry + biospecimen collection format. Subjects will be enrolled at participating Sites as they present for care for new traumatic appendicular skeletal fractures (0 - ≤7 Days post-injury) and will provide blood specimens for study analysis and future use at up to 4 post-injury windows of treatment (i.e., Window 1, 0 - ≤7 Days; Window 2, 8 - ≤14 days; Window 3, 15 - ≤42 Days; and Window 4, 43 - ≤84 Days post-injury).
Study Type
OBSERVATIONAL
Enrollment
110
None. Standard of Care (SOC) only.
University of California, Davis Medical Center
Sacramento, California, United States
Indiana University
Bloomington, Indiana, United States
University of Missouri
Columbia, Missouri, United States
Wake Forest University Health Sciences/Advocate Health
Charlotte, North Carolina, United States
Proportion of subjects with correct predicted outcome
The proportion of Subjects who have a correctly prognosed Fracture Healing Outcome (Normal Healing vs. Delayed Healing vs Nonunion) via RNA in peripheral blood when captured during four specific Windows: 1. 0 - ≤7 Days post-injury; and/or 2. 8 - ≤14 days post-injury; and/or 3. 15 - ≤42 Days post-injury; and/or 4. 43 - ≤84 Days post-injury as compared to clinically determined outcomes up to 270 Days post-injury.
Time frame: 0 - 270 days
Intra-Patient Correlation
The intra-patient correlation of RNA-biomarker-driven prognostic calls made by the blinded statistician across windows for those patients who contribute \>1 specimen for RNA-biomarker analysis.
Time frame: 0 - 270 days
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States