An observational study in Humerus Fractures, sponsored by Major Extremity Trauma Research Consortium. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Major Extremity Trauma Research Consortium · Observational
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.
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.
105 studies on the registry are indexed under Humeral Fractures; 19 are open to participants now.
This study's enrollment of 45 is below the median of 91 across 36 observational studies indexed under Humeral Fractures.
Browse Humeral Fractures studies →Major Extremity Trauma Research Consortium is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 7-9 week visit
Ran from Jun 2021 to primary completion in May 2024, 34 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Major Extremity Trauma Research Consortium