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Completed

NCT Number: NCT05735561

Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

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.

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Key information

Conditions

Proximal Humeral Fracture Avascular Necrosis Avascular Necrosis of Humerus Bone Diseases Dislocation Dislocation Shoulder Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shoulder Dislocation Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Columbian Hospital/Fraser Health Authority

New Westminster, British Columbia, V3L 3W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

X-RAY

Diagnostic Test

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.

Primary outcomes

  1. Rates of Avascular Necrosis

    Time frame: 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.

  2. Direction of the Humeral Fracture Dislocation

    Time frame: 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 outcomes

  1. DASH (functional outcome)

    Time frame: 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.

  2. Constant Score (functional outcome)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fraser Orthopaedic Research Society

Network

Registry information

Official study title

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

Acronym: PHF-D

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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