CompletedNot Applicable

Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

Canada25 participantsStarted 2023-02-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rates of Avascular Necrosis

Timeframe: At least 2 years post fracture fixation

Direction of the Humeral Fracture Dislocation

Timeframe: At least 2 years post fracture fixation

Trial details

NCT IDNCT05735561

SponsorFraser Orthopaedic Research Society

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2023-07-31

View on ClinicalTrials.gov More Proximal Humeral Fracture trials