An observational study in Proximal Humeral Fracture, Dislocation and Dislocation Shoulder, sponsored by Fraser Orthopaedic Research Society. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Fraser Orthopaedic Research Society · Observational
The purpose of the study is to see if there is a connection between a proximal humerus fracture dislocation direction and the likelihood of developing avascular necrosis. Utilizing a retrospective cohort from the last ten years we hope to bring consenting patients back for a single visit to have x-rays and complete patient reported outcome measures to assess for evidence of avascular necrosis.
The incidence of proximal humerus fractures continues to increase and is among one of the more common fractures seen in the adult population. Proximal humerus fracture dislocations, however, are less common. Despite the decreased prevalence, fracture dislocations have unique challenges with respect to obtaining an anatomical reduction and more frequently involve an open surgical reduction. In addition, depending on other fracture characteristics, there are various treatment options for the fracture itself. While fracture dislocations ultimately lead to increased AVN and revision surgery, further discussion surrounding the direction of dislocation and how it may influence overall outcomes has not been addressed in the previous literature. The study design utilizes a retrospective cohort from the last ten years, by asking patients who have had a previously surgically treated proximal humerus fracture dislocations to come back to the surgeon's private clinic to complete a single visit assessment. During this assessment the consenting participant will receive x-rays and complete patient reported outcome measures. In conjunction, these will be utilized to assess overall function and the existence of avascular necrosis.
109 studies on the registry are indexed under Shoulder Fractures; 27 are open to participants now.
This study's enrollment of 25 is below the median of 94 across 55 observational studies indexed under Shoulder Fractures.
Browse Shoulder Fractures studies →Fraser Orthopaedic Research Society is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Skeletally mature patients who were surgically treated for their proximal humerus fracture dislocation between 2011 and 2021.
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:
The study doesn't provide any intervention. This group is defined as having a dislocation that is anterior to the glenoid.
The study doesn't provide any intervention. This group is defined as having a dislocation that is posterior to the glenoid.
Diagnostic Test: X-Ray
The study doesn't provide any intervention. This group is defined as having a dislocation that is in varus compared to the glenoid.
Diagnostic Test: X-Ray
The study doesn't provide any intervention. This group is defined as having a dislocation that is in valgus compared to the gelnoid.
Diagnostic Test: X-Ray
Consenting participants will be asked to come into the clinic for a single visit, during this visit they will be asked to complete an x-ray to check for evidence of avascular necrosis.
Rates of Avascular Necrosis
The presence and advancement of avascular necrosis (as classified by the Cruess Classification System) and as assessed on radiographs.
Time frame: At least 2 years post fracture fixation
Direction of the Humeral Fracture Dislocation
As characterized by the direction of the humeral head in relation to the glenoid, based on AP, Lateral, or Axillary x-ray views.
Time frame: At least 2 years post fracture fixation
DASH (functional outcome)
Asking participants to complete the Disabilities of the Arm, Shoulder, and Hand outcome measure as a way of assessing function.
Time frame: At least 2 years post fracture fixation
Constant Score (functional outcome)
Asking participants to complete the Constant Score patient reported outcome measure as a way of assessing participant function.
Time frame: At least 2 years post fracture fixation
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — There is currently no plan to share individual participant data with other researchers, results will of course be shared. However, the hope is that the study might indicate a need for a high powered prospective clinical trial to be completed.
Ran from Feb 2023 to primary completion in Jul 2023, 5 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Fraser Orthopaedic Research Society