Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

Completed

• Conditions: Dislocation Shoulder; Avascular Necrosis; Avascular Necrosis of Humerus; Proximal Humeral Fracture; Dislocation
• Interventions: Diagnostic Test: X-Ray

• Registration Number: NCT05735561
• Lead Sponsor: Fraser Orthopaedic Research Society

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.

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-09
• Study Start: 2023-02-15
• Study First Posted: 2023-02-21
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proximal Humerus Fracture Posterior Dislocation	X-Ray	The study doesn't provide any intervention. This group is defined as having a dislocation that is posterior to the glenoid.
Proximal Humerus Fracture Varus Dislocation	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.
Proximal Humerus Fracture Valgus Dislocation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Royal Columbian Hospital/Fraser Health Authority; 🇨🇦 New Westminster, British Columbia, Canada