Humerus FracturesUNIONNCT05143476
Serum-Protein-Based Indices for the Progression of Fracture Healing and Nonunion
An observational study of Humerus Fractures, run by Major Extremity Trauma Research Consortium at 1 site in United States.
Trial summary
To define a serum protein-based diagnostic for the progression and failure of fracture healing, through the identification of a set of serum proteins that appear at early times of biological healing and show a specific correlation with later radiological and functional signs used to define delayed healing and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Humerus Fractures
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2021to 28 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Skeletally mature, ages 18-70 (inclusive)
- 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
- Approached for consent within two weeks of injury
- Available for follow up at this treatment facility for at least six months
Who cannot join
- Humeral shaft fractures that extend into the articular surface.
- Pathologic fractures.
- Additional long bone injuries or fractures of upper or lower extremity that would compromise outcome assessments of single fracture protein levels.
- Previous retained hardware in humerus from other injuries.
- Soft tissue injury compromising selected treatment method.
- Any injury that involved a trauma activation with entry of more than two AIS codes.
Show all 12Show fewer
- Fractures with vascular injury.
- Pregnant women, potentially pregnant, or lactating women
- 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.)
- Unable to comply with postoperative rehabilitation protocols or instructions (i.e., head injury or cognitively impaired).
- Known metabolic bone disease.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
To define a serum protein-based diagnostic for the progression and failure of fracture healing, through the identification of a set of serum proteins that appear at early times of biological healing and show a specific correlation with later radiological and functional signs used to define delayed healing and non-union.
Read the detailed description
Aim 1 Learning Set: At the earliest time in the study when 10 non-unions have been identified, we will select 10 control patients matched for comorbidities (including a body mass index>40, smoking history, and diabetes) from the group that has been enrolled for comparison to the 10 non-union patients. The proteins showing the most substantial changes in response to either their initial or end point measurements in both healer and non-healer sets will be identified. Temporal clustering and biological assessment tools will be used to identify the biological processes and time frames showing altered serum levels for these markers. A selection process will then use a set of pair wise iterative processes to identify both single markers and multiple marker subsets that show the best correlations to both mRUST and union/nonunion diagnosis prior to the current time that the diagnosis for failed healing is made.
Aim2 Validation Set: As soon as the next group 10 non-union patients are identified a new group of 10 healers will be selected and the target group of protein identified in phase one will be tested for robustness in a second study with this new set of non-healers healers. Assessments of the robustness will be based on level of detection (LOD) and reproducibility of LOD and diagnostic performance. A third assessment will be carried out with the total group of 20 non healers identified in both the first and second phases of the project by rescreening this group against profiles of a final and novel set of 40 new healers. This new set of healers will be selected from the total patient sets of profiles that have been collected across the entire study period and again will be randomly selected and matched for comorbidities. During each subsequent screen we will refine the marker set further taking into account both performance features, qualitative factors related to a protein's biological functions and relationships to the processes of healing, and their correlation to the clinical parameters that we are using to assess progression of healing (union). The last stage of assessment provides an independent technical biochemical/immunological validation for the ten best performing proteins. This assessment will be made using a conventional Western blot assay across a randomized set of 20 profiles from both healers and non-healers who had been previously screened using the microarray format. This last assay is a quality control step for protein identification specification.
- Conditions
- Humerus Fractures
- Keywords
- Limb Fractures, Failure to Progress, Nonunion, Serum Markers
- Medical subject headings
- Humeral Fractures, Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Follow-up visits will be conducted at 4-6, 7-9, 12-16 and 26-32 weeks, from time of fracture. A participant's doctor will perform routine examination of fracture healing. The assessment will include evaluation of gross fracture site motion and presence or absence of radiographic healing, including a mRUST score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Healing Outcomes and Functional Healing Outcomes
The primary outcome for the assessment of fracture healing will be assessed by gross motion and mRUST (modified radiograph union score) score greater than or equal to 6. mRUST score ranges from 4-16 where score greater than or equal to 6 is considered as the predictors of progression to union.
Measured: 7-9 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start26 Jun 2021
- Primary completion2 May 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerus FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Louis Gerstenfeld, PhD, Principal investigator, Boston UniversityRenan C Castillo, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143476
- Sponsor's protocol ID
- W81XWH-19-1-0796
- Acronym
- UNION
- Status last verified
- Feb 2026
- First submitted
- 10 Nov 2021
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum-Protein-Based Indices for the Progression of Fracture Healing and Nonunion
- ClinicalTrials.gov ID
- NCT05143476
- Acronym / sponsor ID
- UNION / W81XWH-19-1-0796
- Conditions
- Humerus Fractures
- Keywords
- Limb Fractures, Failure to Progress, Nonunion, Serum Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To define a serum protein-based diagnostic for the progression and failure of fracture healing, through the identification of a set of serum proteins that appear at early times of biological healing and show a specific correlation with later radiological and functional signs used to define delayed healing and non-union.
Detailed description
Aim 1 Learning Set: At the earliest time in the study when 10 non-unions have been identified, we will select 10 control patients matched for comorbidities (including a body mass index>40, smoking history, and diabetes) from the group that has been enrolled for comparison to the 10 non-union patients. The proteins showing the most substantial changes in response to either their initial or end point measurements in both healer and non-healer sets will be identified. Temporal clustering and biological assessment tools will be used to identify the biological processes and time frames showing altered serum levels for these markers. A selection process will then use a set of pair wise iterative processes to identify both single markers and multiple marker subsets that show the best correlations to both mRUST and union/nonunion diagnosis prior to the current time that the diagnosis for failed healing is made.
Aim2 Validation Set: As soon as the next group 10 non-union patients are identified a new group of 10 healers will be selected and the target group of protein identified in phase one will be tested for robustness in a second study with this new set of non-healers healers. Assessments of the robustness will be based on level of detection (LOD) and reproducibility of LOD and diagnostic performance. A third assessment will be carried out with the total group of 20 non healers identified in both the first and second phases of the project by rescreening this group against profiles of a final and novel set of 40 new healers. This new set of healers will be selected from the total patient sets of profiles that have been collected across the entire study period and again will be randomly selected and matched for comorbidities. During each subsequent screen we will refine the marker set further taking into account both performance features, qualitative factors related to a protein's biological functions and relationships to the processes of healing, and their correlation to the clinical parameters that we are using to assess progression of healing (union). The last stage of assessment provides an independent technical biochemical/immunological validation for the ten best performing proteins. This assessment will be made using a conventional Western blot assay across a randomized set of 20 profiles from both healers and non-healers who had been previously screened using the microarray format. This last assay is a quality control step for protein identification specification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | –Follow-up visits will be conducted at 4-6, 7-9, 12-16 and 26-32 weeks, from time of fracture. A participant's doctor will perform routine examination of fracture healing. The assessment will include evaluation of gross fracture site motion and presence or absence of radiographic healing, including a mRUST score. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Skeletally mature, ages 18-70 (inclusive)
- 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
- Approached for consent within two weeks of injury
- Available for follow up at this treatment facility for at least six months
Key exclusion criteria (12 listed)
- Humeral shaft fractures that extend into the articular surface.
- Pathologic fractures.
- Additional long bone injuries or fractures of upper or lower extremity that would compromise outcome assessments of single fracture protein levels.
- Previous retained hardware in humerus from other injuries.
- Soft tissue injury compromising selected treatment method.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fracture Healing Outcomes and Functional Healing Outcomes
Time frame: 7-9 week visit
The primary outcome for the assessment of fracture healing will be assessed by gross motion and mRUST (modified radiograph union score) score greater than or equal to 6. mRUST score ranges from 4-16 where score greater than or equal to 6 is considered as the predictors of progression to union.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Gerstenfeld, PhD principal investigator
Boston University
Renan C Castillo, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humerus Fractures, run by Major Extremity Trauma Research Consortium at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture Healing Outcomes and Functional Healing Outcomes (time frame: 7-9 week visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.