PHF-D: Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

Sponsor

Fraser Orthopaedic Research Society (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05735561

Collaborator

(none)

Enrollment

Location

6.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Proximal Humeral Fracture Dislocation Dislocation Shoulder Avascular Necrosis Avascular Necrosis of Humerus	Diagnostic Test: X-Ray

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

65 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Proximal Humerus Fracture Anterior Dislocation The study doesn't provide any intervention. This group is defined as having a dislocation that is anterior to the glenoid.
Proximal Humerus Fracture Posterior Dislocation 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 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.
Proximal Humerus Fracture Varus Dislocation 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 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.
Proximal Humerus Fracture Valgus Dislocation 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.

Outcome Measures

Primary Outcome Measures

Rates of Avascular Necrosis [At least 2 years post fracture fixation]
The presence and advancement of avascular necrosis (as classified by the Cruess Classification System) and as assessed on radiographs.
Direction of the Humeral Fracture Dislocation [At least 2 years post fracture fixation]
As characterized by the direction of the humeral head in relation to the glenoid, based on AP, Lateral, or Axillary x-ray views.

Secondary Outcome Measures

DASH (functional outcome) [At least 2 years post fracture fixation]
Asking 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 fixation]
Asking participants to complete the Constant Score patient reported outcome measure as a way of assessing participant function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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