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Blood proteins may reveal broken bone healing problems early

NCT ID NCT05143476

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

45 people

The number who actually took part.

Started

Jun 2021

Finished

Oct 2024

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.