Blood proteins may reveal broken bone healing problems early
NCT ID NCT05143476
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked for proteins in the blood that could tell doctors early on whether a broken arm bone is healing well or might lead to a nonunion (where the bone doesn't heal). Researchers studied 45 adults with simple humerus fractures treated without surgery. They checked blood samples early after injury and compared them to later X-rays and function tests. The goal was to find a simple blood test to predict healing problems, but this was an observational study, not a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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45 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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Oct 2024
- 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
We will consent and enroll up to 180 patients who meet the enrollment inclusion exclusion criteria for this study. In this group we anticipate based on our prior clinical data that about 20 patients would experience failed healing (nonunion) providing us with the ability to identify those protein in the serum that are diagnostic for failed healing. Patient enrollment will take place continuously over a three year period with the two stages of the project initiated when the enrollment numbers are met to carry out each aim of the project. When a patient presents with a humerus fracture he or she will be evaluated (according to standard of care) for possible enrollment in the study. The inclusion /exclusion criteria will be reviewed by the treating surgeon.
- Ages
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18 to 70 years
- 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: 1. Skeletally mature, ages 18-70 (inclusive) 2. Diagnosis of isolated closed extra-articular fractures of the humeral shaft deemed appropriate for closed treatment by immobilization and a sling by the treating physician 3. Approached for consent within two weeks of injury 4. Available for follow up at this treatment facility for at least six months Exclusion Criteria: 1. Humeral shaft fractures that extend into the articular surface. 2. Pathologic fractures. 3. Additional long bone injuries or fractures of upper or lower extremity that would compromise outcome assessments of single fracture protein levels. 4. Previous retained hardware in humerus from other injuries. 5. Soft tissue injury compromising selected treatment method. 6. Any injury that involved a trauma activation with entry of more than two AIS codes. 7. Fractures with vascular injury. 8. Pregnant women, potentially pregnant, or lactating women 9. Immunocompromised based on the medical record and patient reported use of pharmacological medications that would lead to immunocompromise. (i.e., Anti-TNF therapies, or associated therapies for treatment of various rheumatological conditions.) 10. Unable to comply with postoperative rehabilitation protocols or instructions (i.e., head injury or cognitively impaired). 11. Known metabolic bone disease. 12. Severe problems with maintaining follow-up (e.g., patients who are prisoners or homeless at the time of injury or who are intellectually challenged without adequate family support).
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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.
Contacts and locations
Locations
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Boston Medical Center
Boston, Massachusetts, 02118, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.