Simple blood test may forecast bone healing
NCT ID NCT06872775
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether RNA molecules in the blood can predict if a broken bone will heal normally, slowly, or not at all. Researchers will collect blood samples from 110 people with fractures at several time points after injury and compare the RNA test results to actual healing outcomes over 270 days. The goal is to develop a tool that helps doctors identify healing problems early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a simple blood test that helps doctors predict whether a broken bone will heal normally or need extra treatment.
- What could go wrong
- This is an early observational study, not a treatment trial. The RNA test may not prove accurate enough for routine use, and results may not apply to all types of fractures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All patients who provide blood samples and whose clinically determined fracture outcome is known.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: To be eligible to participate in this study, a potential subject must meet ALL of the following criteria: 1. Provision of informed consent for study participation for self in the English language as indicated by a signed and dated, current, and IRB-approved Informed Consent Form (ICF) from 1. patients making their own SOC clinical decisions prior to the time of the 1st blood sample collection, or 2. persons initially unable to make their own SOC clinical decisions, who regain capacity to make clinical care decisions after study blood sample collection during the enrollment window and/or before hospital discharge. 2. Patient is expected to receive follow-up SOC fracture care at the Site. 3. Either biological sex at birth (i.e., male or female). 4. Any self-determined gender or sexual preference. 5. Any race and/or ethnicity combination. 6. Age 18 years or older at the time of enrollment; no maximum age. 7. Body weight estimated to be or measured at ≥110 lbs. 8. Presentation for care within 7 calendar days of injury for at least one new traumatic fracture of any bone in the appendicular skeleton with or without additional fractures of the appendicular or axial skeleton and with or without any other traumatic injuries. 1. A qualifying fracture: * May be open or closed as locally defined per SOC. * May be displaced or non-displaced per SOC. * Must result from blunt or penetrating trauma. * May not be in a location of the body that was chronically paralyzed pre-trauma or has become permanently paralyzed because of the trauma. * Does not include traumatic amputation above the fracture Site for qualifying fractures 2. Index treatment plan: * May be operative or non-operative. * May include staged treatment with or without the use of external fixators, and/or antibiotic beads, and/or other planned intervention. * Does not include hemi- or total arthroplasty to treat the qualifying fracture. * Does not include amputation above the qualifying fracture. 9. In good general health as evidenced by clinical presentation and/or medical history and without any diagnoses that preclude a life expectancy of at least 2 years after injury. 10. No healed or unhealed fractures within 12 months prior to the event resulting in the qualifying fracture. 11. Blood collection through venipuncture at the volume and frequency per protocol is not contraindicated either through past medical history or current clinical status 12. 45 CFR 46 Subpart B: For females of reproductive potential: not pregnant at the time of study enrollment. 13. CFR 46 Subpart C: Does not meet the CFR definition of Prisoner. 14. Other vulnerable populations: 1. Not an individual with pre-existing or newly acquired permanently impaired decision-making capacity , and/or 2. Not an individual who would be considered an economically or educationally disadvantaged person prior to the qualifying injury as determined by the Site study team per Site standards. \- Exclusion Criteria An individual who meets ANY of the following criteria will be excluded from participation in this study: 1. Enrolled in another research study that requires any study-specific blood draws from 0 - ≤84 Days post-injury or a study that prohibits co-enrollment of any kind. 2. Traumatic injuries at presentation are limited to soft tissue injuries and/or axial skeletal fractures. 3. The presentation appendicular fractures is a result of pathological not traumatic mechanism 4. Any other circumstances that in the opinion of the PI would either put the successful completion of the study at risk, and/or which makes study participation unduly burdensome to the Subject.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Indiana University
Bloomington, Indiana, 47401-3654, United States
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University of California, Davis Medical Center
Sacramento, California, 95817, United States
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University of Missouri
Columbia, Missouri, 65211-0001, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Texas Health Science Center at Houston
Houston, Texas, 77030-5400, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Wake Forest University Health Sciences/Advocate Health
Charlotte, North Carolina, 28203, United States
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