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Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

Association Between the Direction of Proximal Humerus Fracture Dislocation and Risk of Avascular Necrosis Following Open Reduction Internal Fixation - An Observational, Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05735561
Acronym
PHF-D
Enrollment
25
Registered
2023-02-21
Start date
2023-02-15
Completion date
2023-08-31
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular Necrosis, Avascular Necrosis of Humerus, Dislocation, Dislocation Shoulder, Proximal Humeral Fracture

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTX-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.

Sponsors

Fraser Orthopaedic Research Society
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients 18 years of age or older * Patients who underwent operative fixation of proximal humerus fracture dislocation at Royal Columbian Hospital between January 2011 and July 2021 * Willing and able to consent and complete patient reported outcome measures * Willing and able to follow the protocol and attend a follow-up visit * Able to read and understand English or have an interpreter available

Exclusion criteria

* Skeletally immature patients * Patient with pathological fractures * Patients who have had previous operative fixation of proximal humerus * Patients treated non-operatively * patients presenting outside of the study duration window * Patients treated by a non-participating surgeon * Deceased patients * Patients unable to complete patient reported outcome measures * Patients declining to come back to the clinic for updated x-rays * Dementia * Incarceration

Design outcomes

Primary

MeasureTime frameDescription
Rates of Avascular NecrosisAt least 2 years post fracture fixationThe presence and advancement of avascular necrosis (as classified by the Cruess Classification System) and as assessed on radiographs.
Direction of the Humeral Fracture DislocationAt least 2 years post fracture fixationAs characterized by the direction of the humeral head in relation to the glenoid, based on AP, Lateral, or Axillary x-ray views.

Secondary

MeasureTime frameDescription
DASH (functional outcome)At least 2 years post fracture fixationAsking participants to complete the Disabilities of the Arm, Shoulder, and Hand outcome measure as a way of assessing function.
Constant Score (functional outcome)At least 2 years post fracture fixationAsking participants to complete the Constant Score patient reported outcome measure as a way of assessing participant function.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026